Localized Prostate Cancer Articles

Articles

  • HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

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    HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03085095

    Sponsor: Myovant Sciences GmbH

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Key Inclusion Criteria:

    1. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
    2. Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with 1 of the following clinical disease state presentations:
    3. Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery; or
    4. Newly diagnosed androgen-sensitive metastatic disease; or
    5. Advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent.
    6. Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nanomoles [nmol]/liter [L]).
    7. Has a serum PSA concentration at the Screening visit of > 2.0 ng/milliliter (mL) (2.0 microgram [μg]/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 μg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 μg/L) above the post interventional nadir.
    8. Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at initial screening and at baseline.

    Key Exclusion Criteria:

    1. In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy.
    2. Previously received gonadotropin-releasing hormone analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for ≤ 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot.
    3. Previous systemic cytotoxic treatment for prostate cancer (for example, taxane-based regimen).
    4. Metastases to brain per prior clinical evaluation.
    5. Participants with myocardial infarction, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months.
    6. Active conduction system abnormalities.
    7. Uncontrolled hypertension.

    View trial on ClinicalTrials.gov


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    Published August 2, 2018
  • Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial.

    For prostate cancer treatment, treatment options with minimal side effects are desired. External beam radiation therapy (EBRT) is non-invasive, standard of care and delivered in either conventional fractionation over 8 weeks or with moderate hypo-fractionation over about 5 weeks.

    Published August 24, 2017
  • Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

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    Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01059513

    Sponsor: Jonsson Comprehensive Cancer Center

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level <10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).
    • The ability to understand and willingness to sign a written informed consent are necessary.

    Exclusion Criteria:

    • Patients with tumor parameters that fall outside of the inclusion criteria.
    • Patients with evidence on imagining (bone scan, CT, or MRI) suggestive of disseminated disease.
    • Patients who have had any form of prior prostate treatment (surgery, radiotherapy, cryotherapy, high intensity focused ultrasound, TURP).
    • A prior course of hormone therapy (androgen deprivation) of greater than 3 months duration.
    • The use of other concurrent investigational agents.
    • There are no exclusions due to co-morbid disease or illnesses except for patients with severe inflammatory bowel disease.
    • No life expectancy restrictions will apply.
    • Performance status will not be considered.

    View trial on ClinicalTrials.gov


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    Published January 21, 2018
  • Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate

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    Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00809991

    Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum 100 Years
    • Gender: Male

    Inclusion Criteria:

    • Histologically confirmed, locally confined adenocarcinoma of the prostate
    • Clinical stages T1a to T2b PSA of less than 10 ng per ml
    • Gleason score of less than 3+4=7
    • The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer
    • Signed study-specific consent form prior to registration

    Exclusion Criteria:

    • Stage T3 to 4 disease
    • Gleason 4+3=7 or higher score
    • PSA greater than 10 ng per ml
    • Clinical or Pathological Lymph node involvement N1
    • Evidence of distant metastases M1
    • Radical surgery for carcinoma of the prostate
    • Previous Chemotherapy or pelvic radiation therapy
    • Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years
    • History of inflammatory bowel disease
    • Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer: a Prospective Cohort.

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    Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer: a Prospective Cohort.


    Condition: Prostatic Neoplasms

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT02651896

    Sponsor: Hospital Sirio-Libanes

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate
    2. Patients older than 18 years old
    3. Patients who accept to perform follow up in the radiation oncology department
    4. Performance Status ≥ 70
    5. Written informed consent

    Exclusion Criteria:

    1. Prior pelvic radiotherapy, radical prostatectomy, brachytherapy, cryotherapy or other local treatment
    2. Presenting with positive pelvic lymph nodes or metastatic at the diagnosis (M1)

    View trial on ClinicalTrials.gov


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    Published July 27, 2018
  • Hypofractionated Radiosurgery for Localised Prostate Cancer

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    Hypofractionated Radiosurgery for Localised Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03795337

    Sponsor: University Hospital Schleswig-Holstein

    Eligibility:

    • Age: minimum 60 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0
    • Gleason-grade ≤7
    • Guideline-based staging
    • Age ≥ 60 years
    • PSA < 15 ng / ml
    • Volume of the prostate < 80 cm³
    • IPSS-Score ≤ 12
    • Written informed consent

    Exclusion Criteria:

    • Age ≤ 60 years
    • History of prior pelvic radiotherapy
    • Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),
    • Immunosuppressive therapy
    • Relevant comorbidity thought to adversely affect treatment compliance,
    • Legal incapacity or lack of informed consent

    View trial on ClinicalTrials.gov


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    Published March 4, 2020
  • Hypoxia and Stem Cell Content as Aggression Factors in Prostate Cancer

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    Hypoxia and Stem Cell Content as Aggression Factors in Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02095249

    Sponsor: University Health Network, Toronto

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Prostate cancer patients with bulky intermediate risk or high-risk disease who have already agreed to undergo an open radical prostatectomy at Princess Margaret Cancer Centre-UHN:
    • Clinical stage T2-T3 N0 M0
    • Pathology of adenocarcinoma of the prostate AND
    • Gleason score 7 with >/= 50 % biopsies involved with tumour; OR
    • Gleason score 8 or above (any percentage of biopsies)

    Exclusion Criteria:

    • Patients with clinical T4, N1 or M1 disease
    • Patients with histologies other than adenocarcinoma
    • Patients unable to ingest pimonidazole tablets

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • Impact of F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer

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    Impact of F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00963755

    Sponsor: University of Lausanne Hospitals

    Phase:

    Eligibility:

    • Age: minimum N/A maximum 80 Years
    • Gender: Male

    Inclusion Criteria:

    • Age ≤ 80 years
    • Karnofsky index ≥ 80
    • First prostate biopsy
    • Presence of at least one of the following:
    • Total PSA 10 ng/mL
    • Total PSA 2.5-10 ng/mL with free-PSA <20% and/or PSA velocity 0.75 ng/mL/year
    • Suspicious hypoechoic lesion at TRUS and/or suspicious finding at digital rec¬tal examination
    • Informed signed consent. Exclusion Criteria:
    • Impaired capacity to consent
    • Coexistence of clinically-proven prostate cancer
    • Neoadjuvant hormonal treatment (including 5-α reductase inhibitors)
    • Contraindications to surgery
    • Contraindications to MR Imaging (see below) PROSTATE CANCER RELAPSE Inclusion Criteria:
    • Age ≤ 90 years
    • Karnofsky index ≥ 80
    • Previous treatment for prostate cancer
    • No clinical recurrence based on standard work-up (abdominal / pelvic CT, MRI, and bone scintigraphy)
    • Biochemically proven relapse of prostate cancer (PSA > 0.2 ng/mL after prostatectomy, nadir PSA+2 ng/mL (Phoenix definition) or ≤ 3 successive rising PSA levels (ASTRO definition) after curative radiotherapy).
    • Informed signed consent.

    Exclusion Criteria:

    • Impaired capacity to consent
    • Coexistence of clinically-proven prostate cancer
    • Neoadjuvant hormonal treatment (including 5-α reductase inhibitors)
    • Contraindications to surgery
    • Contraindications to MR Imaging (see below) PROSTATE CANCER RELAPSE Inclusion Criteria:
    • Age ≤ 90 years
    • Karnofsky index ≥ 80
    • Previous treatment for prostate cancer
    • No clinical recurrence based on standard work-up (abdominal / pelvic CT, MRI, and bone scintigraphy)
    • Biochemically proven relapse of prostate cancer (PSA > 0.2 ng/mL after prostatectomy, nadir PSA+2 ng/mL (Phoenix definition) or ≤ 3 successive rising PSA levels (ASTRO definition) after curative radiotherapy).
    • Informed signed consent. Exclusion Criteria:
    • Coexistence of another clinically-proven cancer
    • Contraindications to surgery or radiation therapy treatment

    View trial on ClinicalTrials.gov


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    Published February 27, 2018
  • Integration of Cancer Health Activities Into African American Churches

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    Integration of Cancer Health Activities Into African American Churches


    Condition: Breast Cancer, Prostate Cancer, Colorectal Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03178383

    Sponsor: University of Maryland, College Park

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Advisory Panel members: adults ages 21+
    • Pastors, representing each of the 14 churches enrolled in the project: active pastor of churches enrolled in the study
    • Community Health Advisors
    • Self-identified African American
    • Adults ages 21+
    • Regularly attend church services
    • Able to complete Project HEAL training
    • Able to recruit 40+ participants for a breast, prostate, or colorectal cancer educational workshop
    • Able to lead the breast, prostate, and colorectal cancer workshops
    • Workshop Participants
    • Self-identified African American
    • Adults ages 21+
    • Have no history of breast, prostate, or colorectal cancer

    Exclusion Criteria:

    • Workshop Participants: Men and women who have had breast, prostate, or colorectal cancer

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer

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    Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02265159

    Sponsor: University of Zurich

    Phase: Phase 2/Phase 3

    Eligibility:

    • Age: minimum 40 Years maximum 99 Years
    • Gender: Male

    Inclusion Criteria:

    • Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies
    • Template biopsy:
    • unilateral disease (Gleason ≤4+3)
    • bilateral disease: presence of clinically significant cancer in both sides (Gleason ≤4+3) OR clinically insignificant disease with a burden of >50% of biopsy cores taken on that side, OR bilateral clinically insignificant disease and <50% of biopsy cores positive on any one side but with dominant disease burden on one side
    • Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted)
    • Serum PSA ≤15
    • Life expectancy of ≥10 years
    • Signed informed consent by patient
    • An understanding of the German language sufficient to understand written and verbal information about the trial and consent process

    Exclusion Criteria:

    • Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
    • Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
    • Men with an inability to tolerate a transrectal ultrasound
    • Men with latex allergies as the HIFU probe is covered with a latex condom sheath prior to insertion into the back passage
    • Men who have undergone prior significant rectal surgery preventing insertion of trans-rectal HIFU probe (decided on the type of surgery in individual cases)
    • Men who have had previous HIFU, cryosurgery, thermal or microwave therapy to the prostate.
    • Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.
    • Men not fit for major surgery as assessed by a Consultant Anaesthetist
    • Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
    • Presence of metal implants/stents in the urethra
    • Presence of prostatic calcification and cysts (on transrectal ultrasound) whose location will interfere with effective delivery of HIFU therapy
    • Men with renal impairment with a glomerular filtration rate of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

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    Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer


    Condition: Prostate Cancer, Sexual Dysfunction and Infertility, Sexuality

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01982058

    Sponsor: Rutgers, The State University of New Jersey

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Patient has a primary diagnosis of localized prostate cancer (T1, T2, N=0 M=0, T3 N=0 M=0)
    • Patient had surgery or initiated radiation treatment (brachytherapy or external beam radiation) or began pre-radiation Androgen deprivation therapy within the past 12 months.
    • Patient is currently married or living with a partner, with relationship duration at least 1 year
    • Patient and partner live within a 1 hour commuting distance to recruitment site
    • Patient and partner read and speak English
    • Patient has an Impact of Events Scale (IES) score greater than or equal to 16 and/or partner has an IES score greater than or equal to 17.

    Exclusion Criteria:

    • Patient had a previous definitive treatment for prostate cancer
    • Patient has a concurrent diagnosis of another cancer (other than non-melanoma skin cancer)
    • Partner is diagnosed with cancer (other than non-melanoma skin cancer)
    • Patient or partner have a significant hearing impairment

    View trial on ClinicalTrials.gov


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    Published October 13, 2018
  • Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy

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    Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy


    Condition: Circulating Tumor Cells

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT02449837

    Sponsor: UNC Lineberger Comprehensive Cancer Center

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum 99 Years
    • Gender: All

    Inclusion Criteria:

    • Histologically confirmed cancer, fitting one of the following cohorts: locally advanced head and neck cancer but no distant metastasis scheduled to receive radiotherapy to the head and neck region with or without chemotherapy/targeted therapy (palliative or curative intent); locally advanced cervical cancer without distant metastasis scheduled for radiotherapy to the pelvic region with or without chemotherapy/targeted therapy (palliative or curative intent); Stage I to III non-small cell lung cancer, without distant metastasis, scheduled to receive stereotactic body radiotherapy for early stage lung disease and/or external beam radiotherapy for locally advanced lung disease, with or without concurrent/sequential chemotherapy and/or targeted therapy (curative intent); metastatic prostate cancer scheduled for palliative radiotherapy, or biochemically recurrent prostate cancer following radical prostatectomy; scheduled for salvage prostatic fossa radiotherapy, with or without androgen deprivation or with high risk prostate cancer; locally advanced rectal cancer (no distant metastasis) scheduled to receive neoadjuvant chemoradiotherapy (curative intent); oligometastatic cancer, defined as any solid malignancy with< 5 measurable sites of metastatic disease, limited to a maximum of 3 anatomic organ systems, excluding the primary tumor and regional lymph nodes. At least 1 site of metastatic disease, but as many as all 5 sites, in addition to the primary tumor and regional lymph nodes, is amenable to local ablative therapy with external beam radiation, stereotactic cranial radiosurgery (SRS) or stereotactic body radiotherapy (SBRT). Treatment will be guided by multi-disciplinary evaluation and may also include surgery, chemotherapy or target agents at the discretion of the primary oncologists. Patients may present with oligometastatic disease or have oligometastatic disease recurrence after definitive therapy for localized disease; Melanoma or metastatic NSCLC scheduled to receive ipilimumab, nivolumab, and/or pembrolizumab.; Locally advanced head and neck cancer (HNSCC) scheduled to receive induction chemotherapy followed by radiotherapy; Metastatic breast cancer scheduled to receive any treatment, including radiation therapy and/or systemic/hormonal therapy; Stage III endometrial cancer scheduled to receive radiation therapy
    • Scheduled to initiate radiation for management of their disease, and schedule accommodates blood sample collection prior to radiation
    • Male and female of ≥18 years of age
    • Male and female patients capable of reproduction must agree to use medically acceptable methods of contraception, such as an intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence during radiation therapy. Inclusion of females of childbearing potential requires a negative pregnancy test within 14 days prior to study initiation (part of standard of care in radiation oncology).
    • Written informed consent obtained and signed
    • Able to have blood collection without excessive difficulty

    Exclusion Criteria:

    • Patient unwilling or unable to complete informed consent
    • Physical or psychological inability to complete sample collection for any reason including but not limited to: inability to tolerate any study procedures, any physical limitation that would undermine the safety of the subject in the study, or any psychiatric or neurological condition that inhibits full comprehension of study requirements and inability to complete informed consent, as determined by treating physician
    • Currently pregnant or lactating women

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy

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    Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00375687

    Sponsor: Kaunas University of Medicine

    Eligibility:

    • Age: minimum 40 Years maximum 80 Years
    • Gender: Male

    Inclusion Criteria:

    • preoperative PSA>20ng/ml
    • postoperative PSA >0.2 ng/ml
    • Gleason > 7
    • pT3b
    • signated infomed consent

    Exclusion Criteria:

    • neoadjuvant hormonaltherapy before RP
    • R1 RP
    • N+ RP
    • unstable cncomitant conditions

    View trial on ClinicalTrials.gov


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    Published February 6, 2017
  • Is More Always Better? An Assessment of the Impact of Lymph Node Yield on Outcome for Clinically Localized Prostate Cancer with Low/Intermediate Risk Pathology (pT2-3a/pN0) Managed with Prostatectomy Alone.

    The clinical impact of lymph node dissection extent remains undetermined in the contemporary setting, as reflected in care pattern variations. Despite some series demonstrating a direct relationship between number of lymph nodes identified and detection of nodal involvement, the correlation between lymph node yield and disease control or survival outcomes remains unclear.

    Published October 30, 2017
  • Is There a Role for Using NMR Urine Metabolomics as a New Method of Screening for Colorectal Cancer?

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    Is There a Role for Using NMR Urine Metabolomics as a New Method of Screening for Colorectal Cancer?


    Condition: Colorectal Cancer, Colorectal Polyps

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01486745

    Sponsor: University of Alberta

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum 90 Years
    • Gender: All

    Inclusion Criteria:

    • For Screening group (normal colonoscopy & colonic polyps):
    • asymptomatic, 50-75 year old, without personal or family history of CRC/polyps
    • asymptomatic, 40-75 year old, known personal or first-degree family history of either CRC or polyps For Cancer group:
    • any patient with diagnosis of colorectal cancer
    • any patient with diagnosis of prostate cancer
    • any patient with diagnosis of breast cancer

    Exclusion Criteria:

    • For screening group:
    • hematochezia
    • inflammatory bowel disease
    • on anticoagulation for reasons other than atrial fibrillation
    • significant co-morbidities For Cancer group:
    • already had neoadjuvant treatment at time of urine collection
    • no invasive cancer at time of urine collection

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • LCCC 1636: Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients

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    LCCC 1636: Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients


    Condition: Prostate Cancer, Bladder Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT03156244

    Sponsor: UNC Lineberger Comprehensive Cancer Center

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • 18 years or older
    • Non-Hispanic Black and White patients with a known pathologic diagnosis of prostate or bladder cancer and intent to undergo treatment.
    • Signed, IRB approved written informed consent.

    Exclusion Criteria:

    • Initiation of cancer-directed treatment
    • Race/ethnicity other than Non-Hispanic Black or Non-Hispanic White
    • Inability to read and speak English
    • Inability to comply with study for any other reason than language
    • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Localised Cancer of Prostate and Androgen Deficiency.

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    Localised Cancer of Prostate and Androgen Deficiency.


    Condition: Cancer of Prostate

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02235142

    Sponsor: Hopital Foch

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Male patients over than 18 years of age, with localized, stage I or II prostate cancer, not receiving local treatment (radiation, phototherapy, thermotherapy,…) or hormonal therapy, showing indication of radical prostatectomy.

    Exclusion Criteria:

    • Absence of radical prostatectomy indication
    • Patient received local or hormonal therapy prior to surgery
    • Patients already enrolled in other clinical study incompatible with the study
    • Patients on a treatment which can affect hormonal level (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride)

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer

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    Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer


    Condition: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02163317

    Sponsor: Case Comprehensive Cancer Center

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Patients must have a histologically confirmed diagnosis of adenocarcinoma of the prostate
    • Patient must have a history/physical examination with digital rectal examination of the prostate within 90 days prior to screening
    • Eastern Cooperative Oncology Group (ECOG) performance status must be level 0 or 1 within 60 days prior to registration
    • Patient must have a histological evaluation of the prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores ≤ 7(3+4)
    • Serum creatinine ≤ 1.5 times upper limit of institutional normal (normal: ≤ 1.17 mL/min/1.73 m^2)
    • Clinical stage a ≤ T1-T2a (American Joint Committee on Cancer [AJCC] 7th edition)
    • Prostate specific antigen (PSA) ≤ 10 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
    • Subjects must have the ability to understand and the willingness to sign a written informed consent document
    • Patient willing and able to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire (baseline, 6, 12 and 24 months post end of radiation therapy)
    • Patients must be able to undergo an MRI with contrast
    • Bone scan completed within 90 days

    Exclusion Criteria:

    • Evidence of distant metastases
    • Regional lymph node involvement
    • Previous radical surgery (prostatectomy), cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer
    • Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
    • Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol [DES]), or surgical castration (orchiectomy)
    • Use of finasteride within 30 days prior to registration; PSA should not be obtained prior to 30 days after stopping finasteride
    • Use of dutasteride within 90 days prior to registration; PSA should not be obtained prior to 90 days after stopping dutasteride
    • Previous or concurrent cytotoxic chemotherapy for prostate cancer
    • Severe, active co-morbidity, defined as follows:
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study)
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
    • Patients unable to undergo an MRI with contrast

    View trial on ClinicalTrials.gov


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    Published October 13, 2018
  • Molecular biomarkers to guide precision medicine in localized prostate cancer.

    Major advances through tumor profiling technologies, that include next-generation sequencing, epigenetic, proteomic and transcriptomic methods, have been made in primary prostate cancer, providing novel biomarkers that may guide precision medicine in the near future.

    Published June 29, 2017
  • Molecular Mechanisms Underlying Prostate Cancer Disparities.

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    Molecular Mechanisms Underlying Prostate Cancer Disparities.


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02229565

    Sponsor: Duke University

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Suspected malignancy of prostate cancer
    • Self-reported race of African American or Caucasian American
    • Age >/= 18 years
    • Able to read, understand and sign an informed consent document

    Exclusion Criteria:

    • Collected tumor tissue is inadequate for DNA and RNA analysis and/or is not positive for adenocarcinoma of the prostate.
    • Patients with prior systemic therapy will not be eligible for the study, i.e. radiation or chemo or immunotherapy.

    View trial on ClinicalTrials.gov


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    Published April 11, 2018
  • Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy

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    Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy


    Condition: Cancer, Fatigue

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00852111

    Sponsor: National Institute of Nursing Research (NINR)

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • To be included, patients must meet all of the following criteria:
    • Clinically localized prostate cancer with or without prior prostatectomy;
    • Scheduled to receive EBRT either by 3D conformal or IMRT techniques that is not anticipated to change during the course of the study, with or without ADT;
    • No known medical history of tuberculosis (TB);
    • Able to provide written informed consent by passing at least 80% of the consent quiz;
    • Greater than or equal to18 years of age; The control group must meet all the inclusion criteria mentioned above except for number 2. The control group must not be receiving any form of treatment for their prostate cancer to include hormone, immune, radiation, or chemotherapy.

    Exclusion Criteria:

    • All participants with any one of the following criteria will be excluded: Progressive or unstable disease of any body system causing clinically significant fatigue, including cardiovascular, pulmonary, gastrointestinal, central nervous system, psychiatric, endocrine, hematologic, renal, or immunologic disorders, and including patients with any of the following broad disease categories:
    • Systemic infections (e.g., human immunodeficiency virus (HIV), active hepatitis);
    • Documented history of major depression, bipolar disease, psychosis, or alcohol dependence/abuse within the past 5 years;
    • Uncorrected hypothyroidism and anemia;
    • Chronic inflammatory disease that may be anticipated to alter the proinflammatory cytokine profile (i.e. rheumatoid arthritis, systemic lupus erythematosus, and cirrhosis). Patients taking tranquilizers, steroids, and nonsteroidal anti-inflammatory agents because these medications are known to affect cytokine production; Patients who have second malignancies or those receiving chemotherapy with their EBRT. In addition to the above criteria, participants with the following conditions will be excluded from participating in the exercise interventions: 1. Significant Restrictive or Obstructive Lung Disease 2. Ischemic heart disease 3. Left ventricular dysfunction 4. Acute corpulmonale 5. Cardiomyopathy (dilated, hypertrophic, or non-idiopathic) 6. Significant renal or hepatic dysfunction 7. Disabling stroke 8. Uncontrolled diabetes mellitus with a history of diabetic ketoacidosis 9. Mitochondrial disease Participants unable to pass the English comprehension test will be unable to take the Computer Assessment of Mild Cognitive Impairement (CAMCT) test but will be asked to complete the other outcome measures of the study. Self report of color-blindness, verified by taking the Ishihara card test and scoring greater than 14 (more or less than 10 minutes), will exclude a participant from taking the STROOP test, but will be asked to complete the other outcome measures of the study. This card test will be administered only if the patient states they are color blind.
    • Individuals capable of becoming pregnant.

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • MRI (Magnetic Resonance Imaging) Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

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    MRI (Magnetic Resonance Imaging) Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon


    Condition: Prostate Cancer, Hypothermia, Urinary Incontinence, Erectile Dysfunction

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01979848

    Sponsor: University of California, Irvine

    Phase:

    Eligibility:

    • Age: minimum 21 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. A male older than 21 years of age and under age of 80 who does not have prostate cancer and is not enrolled in UCI HS# 2008‐6397 (2 male adults to test the MR Temperature Mapping calibration). a. CONTROLS: Option for two non‐cancer adult male volunteers > 21 years old, to test MR Temperature Mapping calibration. These men are not scheduled for / will not undergo the prostatectomy and related thermometry MRI.
    2. A male older than 40 years of age who has confirmed prostate cancer and has decided to receive prostatectomy; and have enrolled in UCI HS# 2008‐6397 or will be receiving the Endorectal Cooling balloon outside of UCI HS# 2008‐6397 as part of a compassionate use.

    Exclusion Criteria:

    1. Have implanted prosthetic heart valves, pacemaker, neuro‐stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
    2. Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
    3. Have a history of renal disease and determined by the doctor not suitable for receiving injection of MR contrast agent,
    4. Unable to lie down still for 60 minutes.
    5. Woman or minor

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

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    MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness


    Condition: Prostatic Neoplasms, Genital Neoplasms, Male, Prostatic Diseases

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01464216

    Sponsor: Oslo University Hospital

    Phase:

    Eligibility:

    • Age: minimum N/A maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Patients suitable for surgery with confirmed prostate cancer, Gleason grade ≥ 3
    • Patient has received no prior treatment for prostate cancer.
    • Patient has adequate renal function: Estimated creatinine clearance ≥ 60 ml/minute.
    • Patient must sign written informed consent according to the protocol approved by the Regional Ethics Committee.

    Exclusion Criteria:

    • Patient with contraindication to MR or MR contrast media according to clinical practice.
    • Patients who want to withdraw for any reason during the study.
    • Patients previously undergone pelvic surgery or radiation therapy

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial

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    Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial


    Condition: Prostate Cancer Early Risk Treated by Radiosurgery, Prostate Cancer Intermediate Risk Treated by Radiosurgery

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01226004

    Sponsor: Florida Robotic Radiosurgery Association

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum 90 Years
    • Gender: Male

    Inclusion Criteria:

    • pathological diagnosis of prostate cancer
    • early or intermediate risk

    Exclusion Criteria:

    • high risk prostate cancer

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Multicenter Prospective Evaluation of a Predictive Test of Late Toxicities After Radiotherapy by the Rate of Radiation Induced CD8 T-Lymphocyte Apoptosis: Application to Breast and Prostate Cancers.

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    Multicenter Prospective Evaluation of a Predictive Test of Late Toxicities After Radiotherapy by the Rate of Radiation Induced CD8 T-Lymphocyte Apoptosis: Application to Breast and Prostate Cancers.


    Condition: Breast Cancer, Prostate Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00893035

    Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum 80 Years
    • Gender: All

    Inclusion Criteria:

    • for prostate cancer patients:
    • localised prostate cancer, histologically proven
    • Absence of metastases (M0) : normal bone scintigraphy
    • Absence of radiological lymph node invasion (N0).
    • Clinical Stage : T ≥ T1c-T2a and < T3b Or T1b or c with PSA ≤ 10 ng/ml . Or T1b or c with Gleason ≥ 6
    • PSA < 30 ng/ml.
    • Signs and symptoms according to NCI/CTC v3.0 < grade 2
    • ECOG Performance status ≤ 1
    • Absence of hip prothesis
    • Absence de endopenian stent
    • Patient aged > 18 and < 80
    • Patient affiliated with social security
    • Written informed consent, dated and signed Exclusion Criteria for prostate cancer patients:
    • Antecedents of invasive cancer (unless if treated more than 5 years ago without evolution) except basocellular carcinoma
    • positive biopsy of seminal vesicle
    • PSA ≥ 30 ng/ml for two successive dosages
    • Previous pelvic irradiation
    • Previous radical prostatectomy for cancer
    • Patients with another systemic disease (cardiovascular, renal, hepatic, pulmonary embolism, etc.) non stabilised or generalised sclerodermitis.
    • Patients known to be HIV seropositive (no specific test is necessary for defining eligibility)
    • Known homozygote ATM (Ataxy telangiectasy) mutation
    • Impossibility for a correct follow up (for social family or geographical reasons)
    • Patients incapable of providing consent, protected majors, vulnerable persons
    • Patients participating in other clinical trials Inclusion Criteria for breast cancer patients:
    • Breast Conservative surgery
    • Non metastatic, M0
    • negative surgical margins
    • T1, T2; negative sentinel lymph node N0, N1 or N2.
    • Signs and symptoms according to NCI/CTC v3.0 < grade 2
    • Patient aged over 18 years and less than 60 or more than 60 with an indication for boost irradiation.
    • Patient affiliated with social security
    • Written informed consent, dated and signed

    Exclusion Criteria:

    • for prostate cancer patients:
    • Antecedents of invasive cancer (unless if treated more than 5 years ago without evolution) except basocellular carcinoma
    • positive biopsy of seminal vesicle
    • PSA ≥ 30 ng/ml for two successive dosages
    • Previous pelvic irradiation
    • Previous radical prostatectomy for cancer
    • Patients with another systemic disease (cardiovascular, renal, hepatic, pulmonary embolism, etc.) non stabilised or generalised sclerodermitis.
    • Patients known to be HIV seropositive (no specific test is necessary for defining eligibility)
    • Known homozygote ATM (Ataxy telangiectasy) mutation
    • Impossibility for a correct follow up (for social family or geographical reasons)
    • Patients incapable of providing consent, protected majors, vulnerable persons
    • Patients participating in other clinical trials Inclusion Criteria for breast cancer patients:
    • Breast Conservative surgery
    • Non metastatic, M0
    • negative surgical margins
    • T1, T2; negative sentinel lymph node N0, N1 or N2.
    • Signs and symptoms according to NCI/CTC v3.0 < grade 2
    • Patient aged over 18 years and less than 60 or more than 60 with an indication for boost irradiation.
    • Patient affiliated with social security
    • Written informed consent, dated and signed Exclusion Criteria for breast cancer patients:
    • Metastatic patients
    • Bilateral breast cancer (concomitant or previous) except in situ
    • T4 or N3 or treated by mastectomy
    • Patients with chemotherapy or neoadjuvant hormonotherapy
    • Patients with a previous other cancer within the last 5 years EXCEPT basocellular carcinoma of the skin or in situ cancer of the uterus.
    • Patients with another systemic disease (cardiovascular, renal, hepatic, pulmonary embolism, etc.) non stabilised or generalised sclerodermia.
    • Pregnant or breast feeding women
    • Patients known to be HIV seropositive (no specific test is necessary for defining eligibility)
    • Known homozygote ATM (Ataxy telangiectasy) mutation
    • Impossibility for a correct follow up (for social family or geographical reasons)
    • Patients incapable of providing consent, protected majors, vulnerable persons
    • Patients participating in other clinical trials

    View trial on ClinicalTrials.gov


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    Published March 5, 2017
  • Multiparametric MRI for Prostate Cancer Localization and Characterization Using Hyperpolarized Pyruvate (13C) Injection

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    Multiparametric MRI for Prostate Cancer Localization and Characterization Using Hyperpolarized Pyruvate (13C) Injection


    Condition: Prostatic Neoplasms

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02647983

    Sponsor: Sunnybrook Health Sciences Centre

    Phase: Phase 1

    Eligibility:

    • Age: minimum 50 Years maximum 80 Years
    • Gender: Male

    Inclusion Criteria:

    • Absolute neutrophil count (ANC) ≥1500 cells/µl
    • Hemoglobin ≥9.0 gm/dL
    • Platelets ≥100,000 cells/µL
    • Estimated creatinine clearance* ≥60 mL/min
    • by the Cockcroft Gault equation
    • Bilirubin within normal range
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within normal range
    • Negative test for hepatitis B and hepatitis C
    • Eastern Cooperative Oncology Group Status of 0 or 1

    Exclusion Criteria:

    • Unable to give valid informed consent
    • Contraindications to MRI or MRI contrast agents
    • A high risk factor for nephrogenic systemic fibrosis (NFS), including being on dialysis
    • Suffering from heart disease, diabetes, single kidney, hypertension/hypotension, a history of renal disease, multiple myeloma, peripheral vascular disease
    • Taking specific medications (loop diuretics, NSAIDs, aminoglycosides, vancomycin, amphotericin B or immunosuppressants)
    • Claustrophobia
    • Prior hormonal or radiation therapy for prostate cancer
    • Active prostatitis, moderate to severe rectal inflammation, previous rectal surgery, or prostate biopsy within 12 weeks of planned MRI
    • Currently or previously taking androgen deprivation therapy (however, use of a 5-α reductase inhibitor is allowed, provided it was discontinued at least 1 month prior to and 1 month following study entry)
    • Have received, or are scheduled to receive, another IMP from 1 month prior to 1 month after inclusion in this study
    • BMI of less than 18.5 or greater than 32
    • Congestive heart failure, a past or present medical history of clinically significant electrocardiogram (EKG) abnormalities, which may include QT prolongation, a family history of prolonged QT interval syndrome, or a myocardial infarction (MI) within the past 12 months with ensuing unstable EKG, or ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer

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    Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03886493

    Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • To be eligible for this study, patients must meet all of the following criteria:
    • Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs
    • Initial prostate biopsy is available for central pathologic review, and is confirmed to show at least 2 positive cores and a Gleason sum of ≥7
    • Radical prostatectomy has been scheduled at Johns Hopkins Hospital
    • Age ≥18 years
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1, or Karnofsky score ≥ 70%
    • Adequate bone marrow, hepatic, and renal function:
    • WBC >3,000 cells/mm3
    • ANC >1,500 cells/mm3
    • Hemoglobin >9.0 g/dL
    • Platelet count >100,000 cells/mm3
    • Serum creatinine <3 × upper limit of normal (ULN)
    • Serum bilirubin <3 × ULN
    • ALT <5 × ULN
    • AST <5 × ULN
    • Alkaline phosphatase <5 × ULN
    • Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
    • Willingness to use barrier contraception from the time of first dose of DUPILUMAB until the time of prostatectomy.

    Exclusion Criteria:

    • To be eligible for this study, patients should not meet any of the following criteria:
    • Presence of known lymph node involvement or distant metastases
    • Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors
    • Prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for prostate cancer
    • Prior immunotherapy/vaccine therapy for prostate cancer
    • Concomitant treatment with other hormonal therapy or 5α-reductase inhibitors
    • Current use of systemic corticosteroids or use of corticosteroids within 4 weeks of enrollment (inhaled corticosteroids for asthma or COPD are permitted)
    • Use of experimental agents for prostate cancer within the past 3 months from time of screening
    • History or presence of autoimmune disease requiring systemic immunosuppression (including but not limited to: inflammatory bowel disease, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis, hemolytic anemia, Sjögren syndrome, and sarcoidosis)
    • History of malignancy within the last 3 years, with the exception of non-melanoma skin cancers and superficial bladder cancer
    • Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate
    • Known prior or current history of HIV and/or hepatitis B/C
    • Significant eye disease

    View trial on ClinicalTrials.gov


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    Published March 22, 2019
  • Open-Label, Pilot Study of Olaparib as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

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    Open-Label, Pilot Study of Olaparib as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer


    Condition: Prostate Adenocarcinoma Without Neuroendocrine Differentiation, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03570476

    Sponsor: University of Washington

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Provision of informed consent prior to any study specific procedures.
    • Histologically confirmed adenocarcinoma of the prostate without morphologic neuroendocrine differentiation or small cell features.
    • The presence of homologous recombination deficiency defined by either; A) Inherited pathogenic variant of BRCA2, ATM, BRCA1, PALB2 by a Clinical Laboratory Improvement Act (CLIA) level germline assay or B) have evidence by somatic sequencing using a CLIA level assay of biallelic inactivation of BRCA1, BRCA2, PALB2, FANCA or biallelic inactivation or monoallelic inactivating mutation of ATM. It is anticipated that the majority of patients will be germline carriers of a pathogenic variant of BRCA1, BRCA2 or ATM. Other germline mutations will be considered at investigator's discretion.
    • Must be candidates for radical prostatectomy and considered surgically resectable by urologic evaluation.
    • No evidence of metastatic disease or nodal disease as determined by radionuclide bone scans and computed tomography (CT)/magnetic resonance imaging (MRI); non-pathological lymph nodes must be less than 20 mm in the short (transverse) axis.
    • Provided written authorization for use and release of health and research study information.
    • Hemoglobin >= 10.0 g/dL with no blood transfusion in the past 28 days.
    • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (within 28 days prior to administration of study treatment).
    • Platelet count >= 100 x 10^9/L (within 28 days prior to administration of study treatment).
    • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment).
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be =< 5 x ULN (within 28 days prior to administration of study treatment).
    • Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of >= 51 mL/min (within 28 days prior to administration of study treatment).
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
    • Patients must have a life expectancy >= 16 weeks.
    • Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for 3 months after last dose of study drug(s) to prevent pregnancy in a partner.
    • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.

    Exclusion Criteria:

    • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
    • Any previous treatment with PARP inhibitor, including olaparib.
    • Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for >= 5 years.
    • Resting electrocardiogram (ECG) with corrected QT interval (QTc) > 470 msec on 2 or more time points within a 24-hour period or family history of long QT syndrome.
    • Patients receiving any systemic chemotherapy, hormonal therapy or radiotherapy.
    • Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
    • Concomitant use of known strong (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents.
    • Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML).
    • Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
    • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
    • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
    • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
    • Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
    • Patients with known active hepatitis (i.e., hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
    • Previous allogenic bone marrow transplant or cord blood transplantation.
    • Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable).

    View trial on ClinicalTrials.gov


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    Published August 19, 2019
  • Optical Coherence Tomography for Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer

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    Optical Coherence Tomography for Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer


    Condition: Lung Cancer, Pleural Cancer, Prostate Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00581503

    Sponsor: University of California, Irvine

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Adult 18 years and older
    • Having procedure of endobronchial, transbronchial, and / or pleural biopsy

    Exclusion Criteria:

    • Currently participating in any other investigational drug or device evaluation.
    • Currently taking drugs that are sensitive to light.

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study

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    Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study


    Condition: Prostate Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01376661

    Sponsor: St. Joseph Hospital of Orange

    Phase:

    Eligibility:

    • Age: minimum 18 Years maximum 90 Years
    • Gender: Male

    Inclusion Criteria:

    • At least 18 years of age
    • Histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. Subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated.
    • PSA < 10 ng/ml within 1 month of program enrollment
    • Clinical stage less than or equal to T2a
    • Biopsy sampling with at least 10-12 cores
    • Gleason score less than or equal to 3 + 3
    • No more than 2 cores involved
    • No core more than 50% involved
    • Eligible for definitive therapy
    • Able to provide informed consent
    • Able to complete a QOL questionnaire
    • Able to comply with the scheduled follow-up appointments

    Exclusion Criteria:

    • See inclusion criteria for eligibility

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Paired CAP: Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer

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    Paired CAP: Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer


    Condition: Elevated PSA, Prostate Cancer

    Study Type: Observational [Patient Registry]

    Clinical Trials Identifier NCT 8-digits: NCT02425228

    Sponsor: Jonsson Comprehensive Cancer Center

    Phase:

    Eligibility:

    • Age: minimum N/A maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Men undergoing a first-time prostate biopsy driven by PSA elevation to rule out cancer.
    • PSA 2.5
    • 20 ng/mL
    • Prostate volume 20
    • 100 cc
    • No prior ablation or TURP
    • Able to tolerate MRI
    • T1c suspect
    • Signed informed consent

    Exclusion Criteria:

    • Any prior prostate biopsy
    • Active bleeding disorder or concurrent use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily stopped for at least 7 days before and 7 days after the biopsy
    • Any prostate ablative procedure, including transurethral resection, photovaporization, or electrovaporization
    • Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis) ,
    • Palpable prostate mass lesion (i.e., Stage >T1c suspected)
    • Any condition that would preclude the subject from getting the required biopsy as stated in the protocol

    View trial on ClinicalTrials.gov


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    Published October 5, 2018
  • Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)

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    Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)


    Condition: Metastatic Malignant Neoplasm in the Bone, Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT04513717

    Sponsor: NRG Oncology

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • PRIOR TO STEP 1 REGISTRATION
    • Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration
    • High-risk disease defined as having at least one or more of the following:
    • PSA > 20 ng/mL prior to starting ADT Note: Patients receiving a 5-alpha reductase inhibitor (ex. finasteride) at the time of enrollment are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors and the medication should be discontinued prior to randomization but a washout period is not required.
    • cT3a-T4 by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.])
    • Gleason score of 8-10
    • Node positive by conventional imaging with a short axis of at least 1.0 cm
    • Appropriate stage for study entry based on the following diagnostic workup:
    • History/physical examination within 120 days prior to registration;
    • Bone imaging within 120 days prior to registration;
    • Note: To be eligible, patient must have no definitive evidence of bone metastases (M0) on bone scan or sodium fluoride (NaF) PET within 120 days prior to registration (negative NaF PET/CT or negative Axumin or choline PET or negative fluciclovine, choline or prostate-specific membrane antigen (PSMA) PET within 120 days prior to registration is an acceptable substitute if they have been performed). Patients who have bone metastases established only fluciclovine, choline, or PSMA PET but not definitive on bone scan or NaF PET will still be eligible
    • CT or MRI of the pelvis within 120 days prior to registration (negative fluciclovine, choline, or PSMA PET within 120 days prior to registration is an acceptable substitute). As with bone staging, nodal staging for trial purposes will be based off of conventional imaging findings only
    • Patients with confirmed N1 metastases on conventional imaging (CT/MRI) as defined by ≥10 mm on short axis are eligible but will be automatically assigned to the intensification study. Patients who are positive by fluciclovine, choline, or PSMA PET (i.e. N1), but whose nodes do not meet traditional size criteria for positivity (i.e. they measure ≥ 10 mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 for the trial and will not automatically be assigned to the intensification study
    • Age ≥ 18
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
    • Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
    • Platelet count ≥ -100 x 10^3/uL independent of transfusion and/or growth factors (within 120 days prior to registration)
    • Creatinine clearance (CrCl) ≥ 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)
    • For Black patients whose renal function is not considered adequate by Cockcroft-Gault formula, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) may be used for calculating creatinine clearance for trial eligibility
    • Either a CrCl ≥ 30 ml/min or calculated glomerular filtration rate (GFR) ≥ 30 will make a patient eligible
    • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 120 days prior to registration)
    • Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject is eligible
    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (within 120 days prior to registration)
    • Serum albumin ≥ 3.0 g/dL (within 120 days prior to registration)
    • The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count ≥ 200 cells/microliter within 60 days prior to registration. Note: HIV testing is not required for eligibility for this protocol. Of note, for patients with HIV in the intensification trial randomized to apalutamide, highly active antiretroviral therapy (HAART) may need to be adjusted to medications that do not interact with apalutamide
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable after or on suppressive therapy within 60 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol
    • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the principal investigator
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
    • PRIOR TO STEP 2 RANDOMIZATION
    • Confirmation of Decipher score
    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 60 days prior. Note: Apalutamide may interfere with HCV drugs. Patients on HCV medications should alert their infectious diseases physician if they get randomized to apalutamide due to the possibility that apalutamide can affect the bioavailability of some HCV medications. HCV viral testing is not required for eligibility for this protocol
    • For patients entering the Intensification Cohort ONLY: Patients must discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to Step 2 randomization

    Exclusion Criteria:

    • PRIOR TO STEP 1 REGISTRATION:
    • Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI)
    • Prior systemic chemotherapy within ≤ 3 years prior to registration; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration
    • Prior radical prostatectomy
    • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
    • Current use of 5-alpha reductase inhibitor. NOTE: If the alpha reductase inhibitor is stopped prior to randomization the patient is eligible
    • History of any of the following:
    • Seizure disorder
    • Current severe or unstable angina
    • New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
    • History of any condition that in the opinion of the investigator, would preclude participation in this study
    • Evidence of any of the following at registration:
    • Active uncontrolled infection requiring IV antibiotics
    • Baseline severe hepatic impairment (Child Pugh Class C)
    • Inability to swallow oral pills
    • Any current condition that in the opinion of the investigator, would preclude participation in this study
    • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone-releasing hormone [LHRH] agonist and oral anti-androgen) is ≤ 60 days prior to registration; Please note: baseline PSA must be obtained prior to the start of any ADT
    • PRIOR TO STEP 2 RANDOMIZATION:
    • Evidence of known gastrointestinal disorder affecting absorption of oral medications at registration
    • For patients entering the Intensification Cohort ONLY: Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] ≥ 160 mmHg or diastolic BP ≥ 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment

    View trial on ClinicalTrials.gov


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    Published July 9, 2022
  • Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

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    Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)


    Condition: Prostate Adenocarcinoma

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT05050084

    Sponsor: NRG Oncology

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration
    • Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria:
    • Has at least one intermediate risk factor (IRF):
    • PSA 10-20 ng/mL
    • Clinical stage T2b-c (digital rectal examination [DRE] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition
    • Gleason score 7 (Gleason 3+4 or 4+3 [ International Society of Urological Pathology (ISUP) Grade Group 2-3])
    • Has ONE or more of the following 'unfavorable' intermediate-risk designators:
    • > 1 immature reticulocyte fraction (IRF)
    • Gleason 4+3=7 (ISUP Grade Group 3)
    • >= 50% of biopsy cores positive
    • Biopsies may include 'sextant' sampling of right/left regions of the prostate, often labeled base, mid-gland and apex. All such 'sextant' biopsy cores should be counted. Men may also undergo 'targeted' sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s)
    • Absence of high-risk features
    • Appropriate stage for study entry based on the following diagnostic workup:
    • History/physical examination within 120 days prior to registration;
    • Negative bone imaging (M0) within 120 days prior to registration; Note: Tc-99m bone scan or sodium fluoride (NaF) positron emission tomography (PET) are allowed. Equivocal bone scan findings are allowed if plain films X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) are negative for metastasis at the concerned site(s). While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for bone imaging, any suspicious findings must be confirmed and correlated with conventional imaging (Tc-99m bone scan, NaF PET, CT, X-ray, or MRI) to determine eligibility based on the latter modalities (e.g. M0 based on conventional imaging modalities)
    • Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +/- abdominal CT or MR), within 120 days prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.0 cm in short axis and/or if biopsy is negative. Note: While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for pelvic imaging, any suspicious findings must be confirmed by conventional imaging (CT, MRI or biopsy). If the findings do not meet pathological criteria based on the latter modalities (e.g. node =< 10 mm in short axis, negative biopsy), the patient will still be eligible
    • Age >= 18
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
    • Non-castrate testosterone level (> 50 ng/dL) within 120 days prior to registration
    • Absolute neutrophil >= 1,000 cells/mm^3 (within 120 days prior to registration)
    • Hemoglobin >= 8.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
    • Platelet count >= 100,000 cells/mm^3 independent of transfusion and/or growth factors (within 120 days prior to registration)
    • Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)
    • For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate
    • Total bilirubin: 1.5 =< institutional upper limit of normal (ULN) (within 120 days prior to registration) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin. If direct bilirubin is less than or equal to 1.5 x ULN, subject is eligible)
    • Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]): =< 2.5 x institutional ULN (within 120 days prior to registration)
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; Note: HIV testing is not required for eligibility for this protocol
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
    • Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
    • For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
    • Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

    Exclusion Criteria:

    • Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, high intensity focused ultrasound [HIFU], laser thermal ablation, etc.) for prostate cancer
    • Definitive clinical or radiologic evidence of metastatic disease (M1)
    • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. History of or current diagnosis of hematologic malignancy is not allowed
    • Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields
    • Previous bilateral orchiectomy
    • Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed
    • Prior use of 5-alpha-reductase inhibitors is allowed, however, it must be stopped prior to enrollment on the study with at least a 30 day washout period before baseline study PSA measure and registration
    • Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration
    • Severe, active co-morbidity defined as follows:
    • Current severe or unstable angina;
    • New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
    • History of any condition that in the opinion of the investigator, would preclude participation in this study
    • Inability to swallow oral pills
    • High risk features, which includes any of the following:
    • Gleason 8-10 [ISUP Grade Group 4-5]
    • PSA > 20
    • cT3-4 by digital exam OR gross extra-prostatic extension on imaging [indeterminate MRI evidence will not count and the patient will be eligible]

    View trial on ClinicalTrials.gov


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    Published June 29, 2023
  • Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent

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    Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02876237

    Sponsor: Institut Cancerologie de l'Ouest

    Eligibility:

    • Age: minimum 75 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. Man with a histologically proven prostate cancer
    2. Indication of a curative intent radiotherapy
    3. Age ≥ 75 years
    4. Patient who signed an informed consent

    Exclusion Criteria:

    1. Patient with metastatic prostate cancer
    2. Patient unable to submit to monitoring of the protocol for social, geographical or family reasons
    3. A person who is not affiliated to a social security scheme or of such a scheme
    4. Patient under trusteeship

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • Perioperative Atezolizumab With MVA-BN-Brachyury and PROSTVAC For Intermediate-Risk And High-Risk Localized Prostate Cancer

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    Perioperative Atezolizumab With MVA-BN-Brachyury and PROSTVAC For Intermediate-Risk And High-Risk Localized Prostate Cancer


    Condition: Prostate Adenocarcinoma

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT04020094

    Sponsor: University of Utah

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Male subjects aged ≥ 18 years.
    • Clinical staged unfavorable intermediate, high-risk or very high-risk prostate cancer per NCCN guidelines.
    • Histologically proven prostate adenocarcinoma
    • Patient must be a surgical candidate
    • ECOG Performance Status ≤ 1.
    • Adequate organ function as defined as:
    • Hematologic:
    • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (without granulocyte colony-stimulation factor support within 2 weeks of screening blood test)
    • Platelet count ≥ 100 × 109/L (without platelet transfusion within 2 weeks of screening)
    • Hemoglobin ≥ 9 g/dL (may not have been transfused within 2 weeks of study treatment initiation)
    • White blood cell count (WBC) ≥ 2.5 × 109/L.
    • Hepatic:
    • Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) (≤ 3 × ULN for subjects with Gilbert's disease)
    • AST and ALT levels ≤ 2.5 × ULN. Patient with a history of unconjugated hyperbilirubinemia with otherwise acceptable liver enzyme levels (as per above criteria) may have higher bilirubin levels.
    • Renal:
    • Urine protein/creatinine ratio (UPCR) ≤ 2 mg/mg (≤ 113.2 mg/mmol) UPCR can be calculated with either a random spot urine test or a 24 hour test. The 24-hour urine collection test is more accurate, so it is the definitive test if there is a discrepancy between the urnialysis and the UPCR. A 24-hour urine test is not required, but may be obtained.
    • Serum creatinine ≤ 2.0 × ULN or calculated creatinine clearance ≥ 30 mL/min (≥ 0.5 mL/sec) using the Cockcroft-Gault equation.
    • Highly effective contraception for male subjects throughout the study and for at least 6 months after last study treatment administration if the risk of conception exists.
    • Patients must have archival prostate biopsy tissue available with identified prostate cancer. If none is available, a repeat prostate biopsy is mandatory to be eligible for this study. The repeat biopsy if performed must have documented prostate adenocarcinoma. The archival tissue must not have been obtained more than 4 months before enrollment.
    • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
    • Prostate MRI must be performed within the past 8 months.

    Exclusion Criteria:

    • Prostate cancer histology other than adenocarcinoma.
    • Previous treatment for prostate cancer.
    • Metastatic disease on imaging (CT, MRI, or NM bone scan) or through tissue biopsy. This includes nodal metastatic disease. A biopsy is not required to rule out metastasis.
    • Use of immunosuppressive medication within 28 days of study treatment initiation, EXCEPT for the following:
    • Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
    • Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
    • Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication).
    • Known history of and/or active autoimmune disease requiring systemic treatment. Patients with diabetes mellitus, thyroid disease, vitiligo, or other diseases determined to be not clinically meaningful (per the treating physician) will not be excluded for these conditions.
    • Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent per treating physician's clinical judgment. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid diseases, or other conditions are eligible as per 5.2.5.
    • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: o Cardiovascular disorders:
    • Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias within 3 months of study enrollment.
    • Uncontrolled hypertension defined as sustained blood pressure (BP) > 180 mm Hg systolic or > 120 mm Hg diastolic despite optimal antihypertensive treatment within 2 weeks of starting treatment.
    • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before first dose.
    • Uncontrolled tumor-related pain.
    • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
    • Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium >ULN).
    • Active Tuberculosis
    • Prior allogeneic stem cell or solid organ transplantation.
    • Known history of acquired immunodeficiency syndrome.
    • Prior or concurrent malignancy whose natural history or treatment, in the opinion of the enrolling investigator, may have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
    • Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Patients with a history of HBV or HCV infection are eligible if the viral load is documented as undetectable at screening. Screening tests for HBV, HCV or HIV are not mandatory by the study but will be performed per the discretion of the study investigators.
    • Known history of atopic dermatitis or active skin condition (acute chronic, or exfoliative) that disrupts the epidermis that is clinically significant less than or equal to 180 days before study enrollment.
    • Known history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
    • Known history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
    • Live, attenuated (e.g., FluMist) and inactive vaccinations within 28 days of study treatment initiation. Live, attenuated vaccinations are generally discouraged for the duration of the investigational treatment phase of the study. Inactive vaccinations are acceptable after the prostatectomy is performed but cannot be given within 1 week of the study vaccine administration. Live vaccinations require PI approval.
    • Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 5.0 Grade ≥ 3).
    • Known allergy to eggs, egg products, or aminoglycoside antibiotics (for example gentamicin or tobramycin).
    • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.
    • Known allergy or hypersensitivity to any component of the PROSTVAC or MVA-BN-Brachyury formulation.
    • Subjects taking prohibited medications as described in Section 6.6. A washout period of prohibited medications for a period of at least 14 days or as clinically indicated should occur prior to the start of treatment.

    View trial on ClinicalTrials.gov


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    Published February 11, 2020
  • Perioperative Pelvic Floor Muscle Training May Improve Recovery of Continence in Men With Localized Prostate Cancer Undergoing Robot-Assisted Radical Prostatectomy

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    Perioperative Pelvic Floor Muscle Training May Improve Recovery of Continence in Men With Localized Prostate Cancer Undergoing Robot-Assisted Radical Prostatectomy


    Condition: Prostate Cancer, Urinary Incontinence, Pelvic Floor Physical Therapy

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02558946

    Sponsor: Indiana University

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Patients scheduling to undergo robot-assisted radical prostatectomy
    • Patients willing and able to complete the EPIC questionnaire in its entirety
    • Ability to provide informed consent

    Exclusion Criteria:

    • Previous prostate surgery
    • Radiation treatment
    • History of incontinence defined as any pad use for urinary leakage in the past 6 months

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • Pharmacogenetic Study in Castration-resistant Prostate Cancer Patients Treated With Abiraterone Acetate

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    Pharmacogenetic Study in Castration-resistant Prostate Cancer Patients Treated With Abiraterone Acetate


    Condition: Pharmacogenetic Study

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01858441

    Sponsor: Centre Antoine Lacassagne

    Eligibility:

    • Age: minimum 18 Years maximum 90 Years
    • Gender: Male

    Inclusion Criteria:

    1. Age > 18 years. Histologically confirmed prostate adenocarcinoma. ECOG ≤
    2. Evidence of metastatic disease by the presence of documented locoregional or distant metastases on CT scan of the abdomen and/or pelvis, or bone scintigraphy. Patients who have had disease progression during or after prior docetaxel chemotherapy regimen, defined as: Progressive measurable disease : At least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed -or- the appearance of one or more new measurable lesions as assessed by CT scan. Soft tissue disease progression defined by modified RECIST 1.1 criteria (baseline lymph node size must be ≥ 2.0 cm to be considered target or evaluable lesion). OR Bone Scan Progression: appearance of 2 or more new lesions on bone scan. OR Increasing serum PSA level: Two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required. If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA is acceptable. A minimum starting value of 2.0 ng/mL is required for study entry. NOTE: Androgen ablative therapy may have included either medical or surgical castration. At least one prior chemotherapy regimen of docetaxel. At least 28 days had to have elapsed between the withdrawal of antiandrogens and enrolment, except LH-RH agonist therapy that must be continued throughout this study for patients who were already treated by it. Hormonal castration confirmed biologically (testosterone < 0.5 ng/ml). Patient with adequate organ function
    3. Patient able to swallow abiraterone acetate whole as a tablet. Information delivered to patient and informed consent signed by the patient or legal representative. Patient affiliated with a health insurance system.

    Exclusion Criteria:

    1. Patients already treated with abiraterone acetate. Known hypersensitivity or allergy to abiraterone or any of the excipients Patients suffering from severe or moderate hepatic impairment (Child-Pugh Class B or C), active or symptomatic viral hepatitis or renal impairment. Any radiation within 28 days prior to study entry. Patient with central nervous system (CNS) metastasis or with history of CNS metastasis. Patient treated for a cancer other than prostate cancer, with the exception of basal cell carcinoma, within the past 5 years. Treatment on another therapeutic clinical trial within 28 days before enrolment Prior treatment with novel hormonal agents including enzalutamide, orteronel, ARN509, EPI100 and novel non hormonal treatments including cabozantinib, alpharadin. Patients with uncontrolled hypertension, heart disease clinically significant (such as myocardial infarction or recent arterial thrombotic events, severe or unstable angina, heart failure class III-IV NYHA (appendix 5) or with a measurement of the cardiac ejection fraction <50%), within 6 months of randomization. Any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy. Permanent contraindication to corticosteroids. Patients who have partners of childbearing potential who are not willing to use refusing 2 methods of birth control with adequate barrier protection during the study and for 13 weeks after last study drung administration. Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol. Patient enables to give informed consent.

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

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    Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care


    Condition: Adenovirus, Anesthesia, Anxiety, Anxiolysis, Autism, Autistic Disorder, Bacterial Meningitis, Bacterial Septicemia, Benzodiazepine, Bipolar Disorder, Bone and Joint Infections, Central Nervous System Infections, Convulsions, Cytomegalovirus Retinitis, Early-onset Schizophrenia Spectrum Disorders, Epilepsy, General Anesthesia, Gynecologic Infections, Herpes Simplex Virus, Infantile Hemangioma, Infection, Inflammation, Inflammatory Conditions, Intra-abdominal Infections, Lower Respiratory Tract Infections, Migraines, Pain, Pneumonia, Schizophrenia, Sedation, Seizures, Skeletal Muscle Spasms, Skin and Skin-structure Infections, Treatment-resistant Schizophrenia, Urinary Tract Infections, Withdrawal, Sepsis, Gram-negative Infection, Bradycardia, Cardiac Arrest, Cardiac Arrhythmia, Staphylococcal Infections, Nosocomial Pneumonia, Neuromuscular Blockade, Methicillin Resistant Staphylococcus Aureus, Endocarditis, Neutropenia, Headache, Fibrinolytic Bleeding, Pulmonary Arterial Hypertension, CMV Retinitis, Hypertension, Chronic Kidney Diseases, Hyperaldosteronism, Hypokalemia, Heart Failure, Hemophilia, Heavy Menstrual Bleeding, Insomnia

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01431326

    Sponsor: Daniel Benjamin

    Phase:

    Eligibility:

    • Age: minimum N/A maximum 21 Years
    • Gender: All

    Inclusion Criteria:

    • 1) Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver

    Exclusion Criteria:

    • 1) Failure to obtain consent/assent (as indicated)
    • 2) Known pregnancy as determined via interview or testing if available.

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Pharmacological Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute

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    Pharmacological Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute


    Condition: Leukemia, Myeloid, Neoplasm Metastasis, Leukemia, Lymphoid, Prostate Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00339664

    Sponsor: National Cancer Institute (NCI)

    Phase:

    Eligibility:

    • Age: minimum N/A maximum 100 Years
    • Gender: All

    Inclusion Criteria:

    1. Any patients entered on approved trials of cancer therapeutics or agents that are commonly administered to patients with cancer at institutions outside of the intramural NCI are eligible for inclusion, provided that they have consented to pharmacological analysis in the original consent form.

    Exclusion Criteria:

    1. None anticipated at this time.

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer

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    Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01094665

    Sponsor: University Health Network, Toronto

    Eligibility:

    • Age: minimum 45 Years maximum 80 Years
    • Gender: Male

    Inclusion Criteria:

    • Men 45-80 years of age;
    • Histologically proven prostate carcinoma;
    • Prostate cancer clinical stage T1c and T2a
    • Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy;
    • Prostate specific antigen (PSA) level less than 15 ng/mL
    • 12 cores biopsy, with histologically proven prostate carcinoma, in the suspicious region on MRI.
    • IPSS and IIEF complete prior to procedure
    • Life expectancy of greater than 5 years, based on co-morbidity not related to prostate cancer.

    Exclusion Criteria:

    • Medically unfit for focal therapy of the prostate
    • Patients who are unwilling or unable to give informed consent;
    • Patients who have received androgen suppression therapy
    • Patients who have received or are receiving chemotherapy for prostate carcinoma;
    • Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including HIFU, TUNA, RITA, microwave, TURP, cryotherapy or any curative treatment
    • Patients who have undergone radiation therapy for prostate cancer or to the pelvis
    • Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies);
    • Patients with a history of non compliance with medical therapy and/or medical recommendations;
    • Patients who are unwilling or unable to complete the patient self-assessment questionnaires;
    • Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
    • Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days;
    • If the patient is unable to undergo regional anesthesia
    • Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)
    • Any condition, or history of illness that, in the opinion of the investigator will confound or increase the patient risk during the study

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage

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    Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00969202

    Sponsor: San Diego Radiosurgery

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum 99 Years
    • Gender: Male

    Inclusion Criteria:

    • Histologically confirmed adenocarcinoma of the prostate
    • Gleason score ≤ 6 and low volume Gleason 7 (3+4)
    • PSA < 10
    • Clinical Stage of T2a or less
    • Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    • Prior radiation treatment for prostate cancer
    • Gleason score > 7
    • PSA > 10
    • Clinical Stage of T2b or greater

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Phase 1 Trial of the Mammalian Target of Rapamycin (mTOR) Inhibitor Everolimus Plus Radiation Therapy (RT) for Salvage Treatment of Biochemical Recurrence in Prostate Cancer Patients Following Prostatectomy

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    Phase 1 Trial of the Mammalian Target of Rapamycin (mTOR) Inhibitor Everolimus Plus Radiation Therapy (RT) for Salvage Treatment of Biochemical Recurrence in Prostate Cancer Patients Following Prostatectomy


    Condition: Prostate Cancer Patients With Detectable PSA Following Prostatectomy

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01548807

    Sponsor: Abramson Cancer Center of the University of Pennsylvania

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Patient must have a history of prostatectomy (Open Radical or Robotic Assisted) with histopathologic documentation of adenocarcinoma of the prostate
    • Patient must have biochemical evidence of PSA including one of the following: a). biochemical recurrence (defined as nadir + 2 rises measured at least 2 weeks apart) and b). PSA doubling time of less than or equal to 6 months; OR c). persistently elevated PSA(PSA post prostatectomy of 0.2 ng/mL if standard assay or greater than 0.05 if ultrasensitive PSA assay)
    • Patient must be a candidate for salvage radiotherapy to the prostate bed
    • Age greater or equal to 18 years
    • ECOG performance status less than or equal to 1
    • Adequate bone marrow function
    • Adequate liver and renal function Adequate renal function: serum creatinine 1.5 x ULN
    • Signed informed consent
    • Patient must have archival prostate tumor block available for analysis of correlatives

    Exclusion Criteria:

    • Indication for lymph node radiation (i.e. evidence of LB node metastases)
    • Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
    • Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
    • Prior treatment with any investigational drug within the preceding 4 weeks
    • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
    • Patients should not receive immunization with attenuated liver vaccines within one week of study entry or during study period. Close contact with those who have received attenuated liver vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines.
    • Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
    • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: 1. . Symptomatic congestive heart failure of New York heart Association Class III or IV 2. . unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease 3. . severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air 4. . uncontrolled diabetes 5. . active (acute or chronic) or uncontrolled severe infections 6. . liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C). Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
    • A known history of HIV seropositivity as everolimus has immunosuppressant properties
    • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
    • Patients with an active, bleeding diathesis
    • Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
    • Patients with a known hypersensitivity to everolimus (RAD001) or other rapamycins (sirolimus, temsirolimus) or to its excipients
    • History of noncompliance to medical regimens
    • Patients unwilling to or unable to comply with the protocol
    • Male patient whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Phase 2 Study of 11C- and 18F-Choline PET/MR Imaging in Patients With Unfavorable Intermediate to High-Risk Prostate Cancer

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    Phase 2 Study of 11C- and 18F-Choline PET/MR Imaging in Patients With Unfavorable Intermediate to High-Risk Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02397408

    Sponsor: University of California, San Francisco

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Age: Patients must be ≥18 years of age
    • Diagnosis: Patients must have a diagnosis of prostate cancer by histologic verification and a hypoechoic lesion seen on ultrasound.
    • Disease Status: Unfavorable intermediate to high-risk prostate Cancer (CAPRA 5-10)
    • Karnofsky Performance Status ≥70
    • Metastatic workup: Whole Body Sodium Fluoride (NaF) PET/CT or 99mTc Bone Scan
    • Planned to undergo radical prostatectomy and extended pelvic lymph node dissection
    • Adequate bone marrow and organ function defined as follows:
    • Adequate bone marrow function:
    • Leukocytes ≥ 3,000/mcL
    • Absolute neutrophil count ≥ 1,500/mcL
    • Platelets ≥ 100,000/mcL
    • Adequate hepatic function:
    • Total bilirubin
    • within normal institutional limits
    • AST (SGOT) ≤ 2.5 X institutional upper limit of normal
    • ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
    • Adequate renal function:
    • Creatinine
    • within normal institutional limits OR
    • Creatinine clearance ≥ 60 mL/min/1.73m2 for patients with creatinine levels above institutional normal
    • Ability to understand a written informed consent document, and the willingness to sign it

    Exclusion Criteria:

    • Participation would significantly delay the scheduled standard of care therapy
    • Karnofsky performance status of < 60
    • Inadequate venous access
    • Administered a radioisotope within 5 physical half lives prior to study enrollment
    • Have a medical condition or other circumstances which, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the study.

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • Phase 2 Study of Enzalutamide and GnRH Agonist Before, During and After Radiation Therapy in Treatment of Patients With High-risk Localized Prostate Cancer

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    Phase 2 Study of Enzalutamide and GnRH Agonist Before, During and After Radiation Therapy in Treatment of Patients With High-risk Localized Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02064582

    Sponsor: University of Texas Southwestern Medical Center

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum 90 Years
    • Gender: Male

    Inclusion Criteria:

    • histologically proven adenocarcinoma of the prostate within 6 months of screening
    • Eastern Cooperative Oncology Group(ECOG) score 0-2
    • adequate organ and and blood marrow function
    • must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer
    • patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment
    • men who are sexually active with female partners of child-bearing potential mush agree to use adequate contraception

    Exclusion Criteria:

    • prior treatment with agents known to have endocrine effects on prostate cancer
    • treatment with corticosteroids within 4 weeks of enrollment
    • treatment with androgens within 6 months of enrollment
    • may not be receiving any other investigational agents
    • Prostate specific antigen greater than 160ng/dL
    • history of malignancy( other than non-melanoma skin cancer) within 5 years
    • uncontrolled intercurrent illness
    • cardiovascular event within 6 months of enrollment
    • seizure or seizure disorder history
    • contraindications to MRI- pacemakers, clips, etc

    View trial on ClinicalTrials.gov


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    Published March 22, 2019
  • Phase 2, Multicenter, Prospective Cohort Study, Estimating the Efficacy of Focused HIFU Therapy in Patients With Localized Intermediate Risk Prostate Cancer

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    Phase 2, Multicenter, Prospective Cohort Study, Estimating the Efficacy of Focused HIFU Therapy in Patients With Localized Intermediate Risk Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03568188

    Sponsor: Hospices Civils de Lyon

    Phase: Phase 2

    Eligibility:

    • Age: minimum 50 Years maximum 80 Years
    • Gender: Male

    Inclusion Criteria:

    • Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
    • Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have a G8 score > 14.
    • Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
    • A multiparametric MRI showing a single invasive tumor focus at most two contiguous sextants confirmed by biopsies (index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by targeted biopsies.
    • Gleason score= 7 (3+4).
    • Tumor accessible to a Focal-HIFU treatment. For apical tumor, it must be localized more than 9 mm from the external sphincter
    • PSA ≤ 15ng / ml.
    • Patient affiliated with health insurance or beneficiary of an equivalent plan.

    Exclusion Criteria:

    • Contraindications to treatment with HIFU-F:
    • Tumor not accessible.
    • Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
    • History of pelvic irradiation
    • Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
    • Fistula of the urinary tract or rectum.
    • Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
    • Anatomical abnormality of the rectum or rectal mucosa.
    • Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
    • History of intestinal inflammatory pathology.
    • Uro-genital infection in progress (the infection to be treated before HIFU treatment).
    • Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
    • Allergy to latex.
    • Thickness of the rectal wall> 10mm.
    • TURP indication. Bladder neck incision is allowed.
    • Patient with a medical contraindication to Sonovue® injection.
    • Patient with a medical contraindication on MRI.
    • Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
    • History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
    • History of pelvic radiotherapy.
    • History of sclerosis of the bladder neck or urethral stenosis.
    • Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy).
    • Patients with unstable neurological pathology.
    • Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
    • Legal person protected by law.
    • Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.

    View trial on ClinicalTrials.gov


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    Published February 13, 2020
  • Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer

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    Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03531099

    Sponsor: Hospices Civils de Lyon

    Phase: Phase 3

    Eligibility:

    • Age: minimum 50 Years maximum 80 Years
    • Gender: Male

    Inclusion Criteria:

    • Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
    • Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have G8 score > 14.
    • Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
    • Only one Target tumor on MRI on a maximum of 2 contigous sextants. Case allowed:
    • If more than one target tumor on MRI, only one of them must be confirmed by targeted prostate biopsies.
    • If no target tumor on MRI, only 2 contigous sextants must be positive on prostate biopsies
    • A maximum tumor length> 3 mm or at least 3 positive biopsies on all biopsies performed (randomized biopsies and/or MRI/Ultrasound Fusion-Guided Prostate Biopsy).
    • Gleason 6 score (risk group 1 of the D'Amico classification).
    • Tumor positioned so that a safety distance of at least 9 mm from external sphincter can be defined during HIFU-FOCAL treatment in prostate tissue around the target.
    • PSA ≤ 15ng / ml.
    • Patient affiliated with health insurance or beneficiary of an equivalent plan.

    Exclusion Criteria:

    • Contraindications to treatment with HIFU-F:
    • Tumor not accessible.
    • Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
    • History of pelvic irradiation
    • Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
    • Fistula of the urinary tract or rectum.
    • Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
    • Anatomical abnormality of the rectum or rectal mucosa.
    • Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
    • History of intestinal inflammatory pathology.
    • Uro-genital infection in progress (the infection to be treated before HIFU treatment).
    • Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
    • Allergy to latex.
    • Thickness of the rectal wall> 10mm.
    • TURP indication. Bladder neck incision is allowed .
    • Patient with a medical contraindication to Sonovue® injection.
    • Patient with a medical contraindication on MRI.
    • Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
    • History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
    • History of sclerosis of the bladder neck or urethral stenosis.
    • Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy if randomized in HIFU-F arm).
    • Patients with unstable neurological pathology.
    • Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
    • Legal person protected by law.
    • Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.

    View trial on ClinicalTrials.gov


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    Published June 14, 2020
  • PHASE I STUDY OF PSMA-TGFβRDN CAR MODIFIED T CELLS IN PATIENTS WITH ADVANCED CASTRATE RESISTANT PROSTATE CANCER

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    Phase I Study of CART-PSMA-TGFβRDN Cells in Patients With Advanced Castrate Resistant Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03089203

    Sponsor: University of Pennsylvania

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • 1. Metastatic castrate resistant prostate cancer 2. ≥10% tumor cells expressing PSMA as demonstrated by immunohistochemistry analysis on biopsied tissue. RETIRED WITH PROTOCOL VERSION 15 3. Radiographic evidence of osseous metastatic disease and/or measurable, non-osseous metastatic disease (nodal or visceral) 4. Patients ≥ 18 years of age 5. ECOG performance status of 0
    • 1 6. Adequate organ function, as defined by: 1. Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 cc/min 2. Serum total bilirubin < 1.5x ULN 3. Serum ALT/AST < 2x ULN 7. Adequate hematologic reserve within 4 weeks of eligibility confirmation by physician-investigator as defined by: 1. Hgb > 10 g/dl 2. PLT > 100 k/ul 3. ANC > 1.5 k/ul Note: Subjects must not be transfusion dependent 8. Evidence of progressive castrate resistant prostate adenocarcinoma, as defined by: 1. Castrate levels of testosterone (< 50 ng/ml) with or without the use of androgen-deprivation therapy AND 2. Evidence of one of the following measures of progressive disease in the 12 weeks preceding eligibility confirmation by physician: i. soft tissue progression by RECIST 1.1 criteria ii. osseous disease progression with 2 or more new lesions on bone scan (as per PCWG2 criteria) iii. increase in serum PSA of at least 25% and an absolute increase of 2 ng/ml or more from nadir (as per PCWG2 criteria) 9. Prior therapy with at least one standard initial therapy for the treatment of metastatic castrate resistant prostate cancer (i.e. docetaxel chemotherapy, 17α lyase inhibitor, or second-generation anti-androgen therapy) 10. Provides written informed consent 11. Subjects of reproductive potential must agree to use acceptable birth control methods

    Exclusion Criteria:

    1. Treatment with immune checkpoint inhibitors and immunoconjugate therapies, including nivolumab, pembrolizumab, atezolizumab, ipilimumab, and/or durvalumab, within 2 months prior to eligibility confirmation by physician-investigator. Cancer vaccine therapies (such as Sipuleucel-T or PROSTVAC) are allowable as a prior line of therapy. Radium-223 is allowable as a prior line of therapy, provided laboratory complete blood counts meet all inclusion criteria as above, without transfusion support in the preceding 4 weeks.
    2. History of an active non-curative non-prostate primary malignancy within the prior 3 years
    3. Subjects with a rising PSA, but who have never had radiologic evidence of metastatic disease (i.e. 'biochemical recurrence') RETIRED WITH PROTOCOL VERSION 6
    4. Subjects who require the chronic use of systemic corticosteroid therapy. Patients may be on a low dose of steroids (≤10mg equivalent of prednisone).
    5. Subjects who have received > 4 prior therapies for the treatment of castrate resistant prostate cancer (excluding luteinizing hormone-releasing hormone agonists or antagonists, or first generation anti-androgen therapies). Note: Docetaxel or abiraterone/prednisone administered in the castration-sensitive setting will count as a prior line of therapy. RETIRED WITH PROTOCOL V13
    6. Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification
    7. Subjects with symptomatic vertebral metastases affecting spinal cord function (as determined by clinical history, physical exam, or MRI imaging)
    8. Active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy
    9. Patients with ongoing or active infection.
    10. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
    11. Active hepatitis B, hepatitis C or HIV infection.
    12. Active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS or CAR Neurotoxicity.

    View trial on ClinicalTrials.gov


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    Published October 30, 2018
  • Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer

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    Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00831623

    Sponsor: Loma Linda University

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically confirmed adenocarcinoma within 180 days of registration
    • History & Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration
    • Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment
    • Clinical stage, Tumor Stage (T1-T2C)
    • Prostatic Specific Angigen (PSA) less than 10 ng.ml within 180 days prior to registration

    Exclusion Criteria:

    • Prior or concurrent invasive malignancy
    • Evidence of distant metastasis

    View trial on ClinicalTrials.gov


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    Published March 5, 2017
  • Phase I/II Study of PROSTVAC in Combination With Nivolumab and / or Ipilimumab in Men With Prostate Cancer

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    Phase I/II Study of PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02933255

    Sponsor: National Cancer Institute (NCI)

    Phase: Phase 1/Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum 120 Years
    • Gender: Male

    Inclusion Criteria:

    • For the neoadjuvant cohort, patients must have histopathological documentation of adenocarcinoma of the prostate prior to starting this study and evaluable biopsy tissue (e.g., unstained slides or blocks) available for analysis. If evaluable tissue is not available, the patient must agree to undergo a pre-vaccination prostate biopsy on study. For the CRPC lead in cohort, if histopathological documentation is unavailable, a rising PSA and a clinical course consistent with prostate cancer would be acceptable.
    • Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of PROSTVAC in combination with nivolumab, ipilimumab or both in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
    • ECOG performance status of 0 or 1.
    • Participants must not have other active invasive malignancies within the past 2 years (with the exception of non-melanoma skin cancers) (for CRPC cohort only).
    • Participants must be willing to travel to the study site for follow-up visits
    • All participants who have received prior vaccination with vaccinia virus (for smallpox immunization) must not have a history of serious adverse reaction to the vaccine.
    • The effects of PROSTVAC in combination nivolumab, ipilimumab or both on the developing human fetus are unknown. For this reason men must agree to use adequate contraception (abstinence, vasectomy) or female partner must use (intrauterine device (IUD), hormonal [birth control, pills, injections, or implants], tubal ligation] prior to study entry and for up to 7 months after the last dose.
    • Participants must understand and sign informed consent that explains the neoplastic nature of their disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation.
    • Participants must have normal organ and marrow function as defined below:
    • hemoglobin greater than or equal to 8 g/dL
    • granulocytes greater than or equal to 1,500/mcL
    • platelets greater than or equal to 100,000/mcL
    • total bilirubin < 1.5 mg/dL (or less than or equal to 3.0 mg/dL in patients with Gilbert syndrome)
    • AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
    • creatinine less than or equal to 1.5 X ULN
    • For the lead in cohort:
    • Castrate testosterone level (<50ng/dl or 1.7nmol /L)
    • Progressive disease at study entry defined as one or more of the following criteria occurring in the setting of castrate levels of testosterone:
    • Radiographic progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer OR
    • PSA progression defined by sequence of rising values separated by >1 week (2 separate increasing values over a minimum of 2ng/ml (PCWG2 PSA eligibility criteria). If participants had been on flutamide, PSA progression is documented 4 weeks or more after withdrawal. For patients on bicalutamide or nilutamide disease progression is documented 6 or more weeks after withdrawal.
    • Participants must agree to continuation of androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone agonist/antagonist or bilateral orchiectomy
    • For all neoadjuvant cohorts:
    • Participants must be a surgical candidate for radical prostatectomy based on standard workup of PSA, biopsy results, and if necessary supplemental imaging.
    • Participants must have chosen radical prostatectomy as their definitive treatment of choice for management of their prostate cancer.
    • No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent IV contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed.

    Exclusion Criteria:

    • Prior splenectomy.
    • The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least 3 weeks after vaccination, their close household contacts (Close household contacts are those who share housing or have close physical contact):
    • persons with active or a history of eczema or other eczematoid skin disorders
    • those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves
    • pregnant or nursing women; children under 3 years of age
    • Participants should have no evidence, as listed below, of being immunocompromised:
    • HIV positivity due to the potential for decreased tolerance and risk for severe side effects.
    • Hepatitis B or C positivity.
    • Concurrent use of systemic steroids or steroid eye drops. This is to avoid immunosuppression which may lead to potential complications with vaccinia (priming vaccination). Nasal, topical or inhaled steroid use is permitted.
    • Participants with known allergy to eggs or to compounds with a similar chemical or biologic composition to PROSTVAC, ipilimumab or nivolumab.
    • No prior immune checkpoint inhibitors (e.g., anti-CTLA4, anti-PD-1 or anti-PDL1) are allowed.
    • Other serious intercurrent illness.
    • Participants with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Association class II IV congestive heart failure.
    • Participants with significant autoimmune disease that is active or potentially life threatening if activated.
    • Participants with clinically significant cardiomyopathy requiring treatment.
    • Participants with ongoing toxicities related to prior therapies targeting T cell coregulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody are excluded
    • No transfusion of blood or blood products within 2 weeks and no G-CSF or GM-CSF within 2 weeks prior to initiations of experimental therapy.
    • Contraindication to biopsy or prostatectomy (for sequential neoadjuvant cohorts only):
    • Bleeding disorders
    • Artificial heart valve
    • PT/PTT greater than or equal to 1.5 in participants not taking anticoagulation. Participants on anticoagulation (e.g. enoxaparin, oral anticoagulants) are eligible regardless of PT/PTT. Prior to biopsy, anticoagulation will be held per standard practice.
    • For participants with localized prostate cancer contraindication to MRI:
    • Participants weighing >136 kilograms (weight limit for the scanner tables)
    • Allergy to MR contrast agent
    • Participants with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices
    • History of radiation proctitis (for lead-in CRPC cohort only)

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate

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    Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate


    Condition: Prostatic Neoplasm

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01540994

    Sponsor: Sharp HealthCare

    Phase: Phase 1/Phase 2

    Eligibility:

    • Age: minimum 50 Years maximum 90 Years
    • Gender: Male

    Inclusion Criteria:

    • Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.

    Exclusion Criteria:

    • Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.

    View trial on ClinicalTrials.gov


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    Published June 29, 2017

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