Prostate Cancer

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A Multi-arm, Phase 2 Study to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed on Second Generation AR-Directed Therapy


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03725761

Sponsor: University of Wisconsin, Madison

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Documented histological or cytological evidence of adenocarcinoma of the prostate
  • Documented metastatic disease on bone scan and/or CT scans
  • Currently receiving enzalutamide, darolutamide, apalutamide and/or abiraterone. Subjects who have received combination enzalutamide/abiraterone or combination apalutamide/abiraterone as part of clinical trials are allowed but will need to be receiving only a single agent ARSI at the time of study enrollment. Subjects who have received any other therapeutic investigational product directed towards the AR or androgen biosynthesis are allowed. Prior treatment with first-generation AR antagonists (i.e., bicalutamide, nilutamide, flutamide) before second generation AR-directed therapy is allowed.
  • Demonstrated disease progression while on enzalutamide, darolutamide, apalutamide, and/or abiraterone. Progressive disease is defined by one or more of the following:
  • A rise in PSA on two successive determinations at least one week apart and PSA level ≥2 ng/mL
  • Soft-tissue progression defined by RECIST 1.1
  • Bone disease progression defined by PCWG2 with ≥2 new lesions on bone scan
  • A minimum serum PSA level of ≥2 ng/mL that is rising based on the PCWG2 criteria
  • ≥18 y ears of age
  • Castrate levels of testosterone (<50 ng/dL [1.74 nmol/L])
  • Undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 months prior to study treatment start. Subjects on LHRH agonists/antagonists must remain on these agents for the duration of the study
  • ECOG Performance Status of 0-1
  • Normal organ function with acceptable initial laboratory values within 30 days of study treatment start:
  • WBC ≥3000/μl
  • ANC ≥1000/μl
  • Platelet count ≥100,000/μl
  • HGB ≥9 g/dL
  • Adequate hepatic function as evidenced by AST/ALT levels <3X the ULN and bilirubin levels of <2.0 mg/dl.
  • Adequate renal function as evidenced by serum creatinine of <2.0 mg/dL
  • Able to provide written informed consent, or have a legal representative provide written informed consent
  • Subjects must have a previously-acquired biopsy from a metastatic site available
  • Subjects must be willing and able (in the opinion of the treating physician) to undergo one research biopsy for the investigational component of this study
  • Subjects who have partners of child-bearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) during the treatment period and for 90 days after last dose of IMMU-132. Subjects must also agree to not donate sperm through 90 days following the last dose of IMMU-132.

Exclusion Criteria:

  • Received prior cytotoxic chemotherapy such as docetaxel, cabazitaxel or platinum chemotherapy for metastatic prostate cancer, castration sensitive or castration resistant, within two years prior to study entry. Neoadjuvant chemotherapy is allowed.
  • Completed sipuleucel-T (Provenge ®) treatment within 30 days of study treatment start.
  • Received any therapeutic investigational agent within 2 weeks of study treatment start.
  • Received palliative radiotherapy within 4 weeks of study treatment start.
  • Received herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (e.g., saw palmetto, PC-SPES, PC-HOPE, St. John's wort, selenium supplements, grape seed extract, etc.) within 4 weeks of study treatment start or plans to initiate treatment with these products/alternative therapies during the entire duration of the study.
  • Active CNS metastases from prostate cancer. Subjects with treated epidural disease are eligible to enroll. Subjects with treated brain metastases can be included as long as >4 weeks have elapsed since last treatment (radiotherapy or surgery) for brain metastases, the subject is neurologically and radiographically stable, and is not receiving corticosteroids for brain metastases. Subjects with untreated brain metastases are excluded. Brain imaging (CT or MRI) is not required at baseline if brain metastases are not clinically suspected.
  • A history within the last 3 years of another invasive malignancy (excluding non-melanoma skin cancer).
  • A QTcF interval of >470 msec on the initial Screening ECG; if the Screening ECG QTcF interval is >470 msec, then it may be repeated two more times, and if the mean QTcF of the 3 ECGs is ≤470 msec, the subject may be enrolled.
  • A history of clinically significant cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes and second degree or third degree atrioventricular heart block without a permanent pacemaker in place. Subjects with resolved or rate-controlled atrial fibrillation/atrial flutter are allowed.
  • NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction/acute coronary syndrome within the preceding 6 months.
  • Diabetes mellitus with more than 2 episodes of diabetic ketoacidosis in the 12 months preceding study treatment start.
  • Inadequately controlled hypertension (defined as blood pressure >150mmHg systolic and/or >100 mmHg diastolic despite antihypertensive medication) or any history of hypertensive crisis or hypertensive encephalopathy.
  • History of loss of consciousness or transient ischemic attack within 12 months before study treatment start.
  • Known active HIV, Hepatitis B, or Hepatitis C infections.
  • Any other medical, psychiatric, or social condition, including substance abuse, which in the opinion of the Investigator would preclude safe participation in the study.

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A Pilot Study Comparing High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy in Localized Prostate Cancer


Condition: 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: NCT04253483

Sponsor: Rutgers, The State University of New Jersey

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the

Eligibility Criteria:

  • and have a recent prostate biopsy (within 9 months)
  • Low-risk and intermediate-risk patients are eligible according to the following guidelines:
  • Low and intermediate-risk disease defined as:
  • Clinical stage T1-T2 and Gleason =< 7 and prostate specific antigen (PSA) < 15 ng/ml
  • Lymph node evaluation by either computed tomography (CT) or magnetic resonance imaging (MRI) and bone scan are optional and are left at the discretion of the treating physician
  • Prostate MRI is recommended by not mandatory
  • No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization
  • Eastern Cooperative Oncology Group status 0-1
  • Judged to be medically fit for brachytherapy by a radiation oncologist
  • Concurrent, neoadjuvant and/or adjuvant androgen deprivation therapy (ADT) is not permitted
  • Prostate volume by trans-rectal ultrasound (TRUS) =< 60 cc
  • International Prognostic Scoring System (IPSS) =< 20 (alpha blockers allowed)
  • Patients must sign a study specific informed consent form prior to study entry
  • Patients must by accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating center. Investigators must assure themselves that patients enrolled in this trial will be available for complete documentation of the treatment, adverse events, and follow up
  • Protocol treatment is to begin within 4 weeks of patient randomization

Exclusion Criteria:

  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumors curatively treated with no evidence of disease for >= 5 years
  • Prior or current bleeding diathesis
  • Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior transurethral resection of the prostate (TURP), prior cryosurgery of the prostate
  • Stage T3b and evidence of nodal or distant metastatic disease on diagnostic CT, MRI or bone scan
  • Subjects who have plans to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as part of the treatment of 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 for 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 within 30 days before registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulations defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immumo-compromised patients
  • Patients with history of inflammatory colitis (including Crohn's disease and ulcerative colitis) or collagen vascular diseases including rheumatoid arthritis and lupus are not eligible
  • Subjects who have a history of significant psychiatric illness
  • Men of reproductive potential who do not agree that they or their partner will use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills

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A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]


Condition: Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03784755

Sponsor: Canadian Cancer Trials Group

Eligibility:

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

Inclusion Criteria:

  • Histologic diagnosis/confirmation of prostate adenocarcinoma and no evidence of small cell cancer.
  • Stage IV at presentation or relapse after curative intent therapy, classification per AJCC 8th edition: M1 disease with ≤ 5 metastases
  • ≤ 3 metastases in any non-bone organ system
  • Zoladex must commence within 12 weeks prior to randomization or within 12 weeks after randomization.
  • Radiology (CT/MRI chest/abdomen/pelvis) within 42 days of randomization
  • Bone scan within 42 days of randomization
  • All tumours (Primary prostate and metastases) must be amenable to local ablative therapy (radiation and/or surgery).
  • Age ≥ 18
  • ECOG performance 0-1
  • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and economics questionnaires in either English or French
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
  • Patients must be medically suitable for study treatments as assessed by the appropriate specialties: medical, radiation, and surgical
  • 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
  • Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
  • In accordance with CCTG policy, ablative therapy to metastases is to begin within 6 weeks after patient randomization
  • Men of childbearing potential must have agreed to use a highly effective contraceptive method to prevent pregnancy while on study
  • Patient must consent to provision of, and Investigator must confirm location of and commit to obtain a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative studies described in the protocol may be conducted. Where tissue exists but local centre regulations prohibit submission of blocks of tumour tissue, the approval of the CCTG must be sought prior to randomization of the first patient to allow cores (two 2 mm cores of tumour from the block) and slides (20 x 5 micron thick unstained slides) of representative tumour tissue to be substituted
  • Patient must consent to provision of samples of whole blood (for cfDNA) in order that the specific correlative studies described in the protocol may be conducted.

Exclusion Criteria:

  • Prior treatment with ADT in the neoadjuvant or adjuvant setting, unless treatment was discontinued ≥ 12 months prior to randomization AND total duration of treatment was ≤ 36 months (including expiry of last depot injection).
  • Previously diagnosed recurrent/metastatic disease which has been already treated with any systemic therapy or radiotherapy
  • Castration resistant prostate cancer, defined as rising PSA (per PCWG3) or radiographic progression in the setting of castrate levels of serum testosterone (< 1.7 nmol/L).
  • Patients who present with de novo stage IV disease with pelvic lymphadenopathy as their only site of metastases (N1 M0), where the primary prostate has never been treated with curative intent prostate surgery or radiotherapy in the past.
  • Inability to treat all sites of disease with local ablative therapy
  • Patients with parenchymal brain metastases

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Radioablation +/- Hormonotherapy for Prostate Cancer Oligorecurrences (RADIOSA Trial): Potential of Imaging and Biology


Condition: Oligometastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03940235

Sponsor: European Institute of Oncology

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically proven initial diagnosis of adenocarcinoma of the prostate;
  • Biochemical relapse of PCa following radical local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant/salvage radiotherapy) +/- ADT according to the European Association of Urology (EAU) guidelines 2016 [18] or after any salvage therapy if biochemical progression is diagnosed in the context of castration sensitive PCa;
  • Nodal relapse in the pelvis, extra-regional nodal relapse (M1a), bone metastases (M1b) on Ch-PET/CT or WBMRI with a maximum of 3 lesions;
  • Serum testosterone level >50 ng/dl at the time of randomization (castration sensitive PCa)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • Age ≥18 years;
  • Written informed consent signed

Exclusion Criteria:

  • Serious concomitant comorbidities or contraindication to SBRT and/or ADT;
  • Previous invasive cancer (within 3 years before the prostate cancer diagnosis) apart from non-melanoma skin malignancies;
  • No ability to complete questionnaires about QoL;
  • Presence of mental diseases that cannot ensure valid informed consent;

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Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04004312

Sponsor: Fabio Cury

Eligibility:

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

Inclusion Criteria:

  1. Histologically proven adenocarcinoma of the prostate. Tl-2b (AJCC 7th edition) Gleason score 6 or 7 (3+4)) or Gleason 7(4+3) and recent PSA < 10 (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride) Recent PSA under 15 ng/dL (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride) OR Gleason 7(4+3) and recent PSA < 10 (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride) International Prostate Symptom Score <16 Prostate gland volume< 80cc Zubrod Performance Status 0-1 within 60 days prior to registration Age >: 18 Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion Criteria:

  1. Patients who opt to receive another treatment modality, such as surgery, or undergo active surveillance. Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer). Evidence of distant metastases Regional lymph node involvement Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy Previous hormonal therapy, such as LHRH agonists or antagonists, anti-androgens, estrogens, 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 CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.

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Phase II Study of Single-Dose Image-Guided Radiotherapy (SDRT) With Urethral Sparing for Localized Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04035642

Sponsor: Fundacao Champalimaud

Eligibility:

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

Inclusion Criteria:

  • Signed study specific informed consent form;
  • Histologic confirmation of adenocarcinoma of the prostate by biopsy;
  • Up to 6 months of previous hormonal therapy is allowed (but not required)
  • PSA ≤ 20 prior to hormone therapy (if given);
  • Biopsy Gleason score ≤ 7
  • No direct evidence of regional or distant metastases after appropriate staging studies
  • Age ≥ 18
  • Performance Status 0-2
  • American Urological Association (AUA) score must be ≤ 20 (alpha blockers allowed)
  • Computerized Tomography (CT) or Ultrasound-based volume estimation of prostate gland ≤ 100 grams

Exclusion Criteria:

  • Positive lymph nodes or metastatic disease from prostate cancer on imaging studies
  • Prior invasive malignancy unless disease free for a minimum of 3 years
  • MRI evidence of radiographic T3, T4 or N1 disease
  • Tumour Clinical stage T3 or T4 on MRI
  • PSA > 20 ng/mL
  • Gleason score > 7
  • Previous pelvic radiotherapy
  • Previous surgery for prostate cancer
  • Recent transurethral resection of the prostate (TURP) (less than 3 months)
  • Previous hormonal therapy given for more than 6 months prior to therapy
  • Previous significant urinary obstructive symptoms;
  • Significant psychiatric illness
  • Ultrasound or CT estimate of prostate volume > 100 grams
  • Severe, active co-morbidity.

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Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04167969

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Primary RP + PLND
  • Age ≥18 years
  • Patients meeting one of the following criteria:
  • Tumor clinical stage T3a or higher
  • Gleason score 8-10, or
  • PSA level > 20 ng/mL
  • Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
  • Patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance) Salvage PLND
  • Age ≥18 years
  • Patients with presence of suspicious lymph node on CT or MRI (of a pelvic node => 10mm in short axis or a node with abnormal morphology such as roundness irregularity or loss of fatty hilum, or PSMA-avid on PSMA PET imaging
  • Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
  • Patient is scheduled for standard of care salvage pelvic lymph node dissection (with or without robotic assistance)

Exclusion Criteria:

  • Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia)
  • Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
  • Prior pelvic radiotherapy (N/A for Salvage PLND )
  • Medical illness unrelated to the tumor that, in the opinion of the attending physician and principal investigator, will preclude administration of the tracer °This includes patients with uncontrolled infection, chronic renal insufficiency (EGFR < 60 mL/min/1.73m2), myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease
  • Weight greater than the 400-lb weight limit of the PET scanner
  • Unmanageable claustrophobia
  • Inability to lie in the scanner for 30 min

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A Phase II Single Arm Study of Fecal Microbiota Transplant (FMT) in Men With Metastatic Castration Resistant Prostate Cancer Whose Cancer Has Not Responded to Enzalutamide + Pembrolizumab


Condition: Prostate Cancer, Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04116775

Sponsor: Julie Graff, MD

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Be willing and able to provide written informed consent/assent for the trial prior to the performance of any protocol-related procedures that are not part of normal care. 2. Be ≥ 18 years of age at the time the informed consent is signed. 3. Histologically or cytologically documented adenocarcinoma of the prostate. Patients without histologically confirmed adenocarcinoma may be eligible if both the treating physician and the study PI agree that the patient's history is unambiguously indicative of advanced adenocarcinoma. 4. Receive care through a Veterans Affairs Hospital or is eligible for care at VHA. 5. Have metastatic castration resistant prostate cancer with castrate-level testosterone (<50 ng/dL). a. Participants must maintain a castrate-level testosterone during the study. 6. Have disease progression defined by one or more of the following three criteria: 1. PSA > 2.0 ng/mL at time of screening and rising PSA by at least 2 consecutive measurements a minimum of 1-week apart. 2. Soft tissue progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 3. Bone disease progression as defined by the PCWG3. 7. Have measurable disease based on RECIST v.1.1 modified as described by the PCWG3 or non-measurable disease with bone metastases. a. Participants with measurable disease must have at least one lesion that is ≥10 mm in longest diameter for a soft tissue lesion, or ≥15 mm in short axis for a lymph node. 8. Have a metastatic lesion that can be safely biopsied and be willing to undergo the tumor biopsy. If the participant is on anticoagulation, it must be safe to hold the anticoagulation for the biopsy. 9. Have had a PSA response to enzalutamide (defined as a PSA decline of 50% or more), but now showing signs of PSA and/or radiographic progression per PCWG3 and/or RECIST 1.1. (Patients must be continuously on enzalutamide prior to joining the main study. They may not have had progression on enzalutamide and then challenge with new therapy and then restarted on enzalutamide.) 10. Participants must discontinue antiandrogen therapy (ie, bicalutamide, flutamide, nilutamide) at least 4-6 weeks prior to registration with no evidence of PSA decline after washout. 1. Bicalutamide: Washout period at least 6 weeks 2. Flutamide and nilutamide: Washout period at least 4 weeks 11. Participants must discontinue therapies for mCRPC, with the exception of enzalutamide and a GnRH agent, for 5 half-lives or 28 days, whichever is shorter. 1. Prior treatment with sipuleucel-T, radium-223, or abiraterone is allowed. 2. Tissue biopsy may be performed during washout period. 12. Have a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. 13. Demonstrate adequate organ function on screening laboratory tests performed within 14 days of treatment initiation and as evidenced by: 1. Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within ≤ 7 days of assessment) 2. WBC > 2,000/mm3 without growth factor support (within ≤ 7 days days of assessment) 3. Absolute neutrophil count ≥ 1,500/mm3 without growth factor support or transfusion (within < 28 days of assessment) 4. Platelet count ≥ 100,000/mm3 5. Serum creatinine < 1.5 x upper limit of normal (ULN) or measured or calculated (calculated per institutional standard) creatinine clearance ≥ 60 mL/min for participant with creatinine levels > 1.5 x institutional ULN. GFR can also be used in place of creatinine or CrCl. 6. Serum total bilirubin < 1.5 x ULN or ≤ 2.0 x ULN for participants with liver metastases
  • Participants with Gilbert's syndrome must have ≤ 3 x ULN and no liver lesions 7. Aspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT) ≤ 2.5 x ULN or ≤ 5.0 x ULN for participants with liver metastases. 8. Albumin ≥ 2.5 mg/dL. 9. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, as long as PT is within therapeutic range of intended use of anticoagulants. 10. Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, as long as PTT is within therapeutic range of intended use of anticoagulants. 14. Male participants of reproductive potential must agree to use an adequate method of contraception, starting with the first dose of study intervention and through 120 days after the last dose of study therapy. Contraception is not required if the patient's partner is a woman who is post-menopausal. Subjects of reproductive potential must agree to avoid impregnating a partner by complying with one of the following: Practice abstinence from heterosexual activity; abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject's preferred and usual lifestyle. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception. OR Have their partner use acceptable contraception during heterosexual activity. Acceptable methods of contraception are: Single method (one of the following is acceptable):
  • Intrauterine device (IUD)
  • Contraceptive rod implanted into the skin. Combination method (requires use of two of the following):
  • Diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)
  • Cervical cap with spermicide (nulliparous women only)
  • Contraceptive sponge (nulliparous women only)
  • Male condom or female condom (cannot be used together)
  • Hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection. 15. Participants must be able and willing to comply with the study visit schedule and study procedures.

Exclusion Criteria:

  1. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy. Superficial bladder cancer is also permitted provided it is monitored and treated locally.
  2. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study intervention. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
  3. Uncontrolled disease-related bone pain or other symptoms that suggest the participant should imminently go onto chemotherapy.
  4. Those with tumors having known microsatellite instability will be excluded. Participants found to have microsatellite instability in their tumors after analysis of the on-study biopsy will not be eligible to serve as FMT donors, but will be permitted on the study.
  5. Prior taxane-based chemotherapy (in any setting- castration sensitive or resistant).
  6. Has had prior therapy with an anti-CTLA4, anti-PD-1 or anti-PD-L1 antibody.
  7. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first dose of study treatment or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  8. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  9. Has had prior targeted small molecule therapy within 2 weeks prior to the first dose of study treatment or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  10. Note: Participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  11. Note: If a participant received major surgery, he must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  12. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  13. Has received broad-spectrum antibiotics within 3 months of first dose of pembrolizumab.
  14. Has a history of seizure, unless he had a mass in his brain that has been removed, such as a meningioma.
  15. Has a diagnosis of immunodeficiency or conditions that need systemic corticosteroid replacement therapy > 10 mg/day prednisone (or equivalent) or other immunosuppressive medications within 28 days prior to the first dose of study intervention. Inhaled steroids are permitted if necessary.
  16. Has any active known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, controlled autoimmune hypothyroidism, psoriasis not requiring systemic treatment, or other conditions under control are permitted to enroll. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy < 10 mg of prednisone/day for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  17. Has a known history of active TB (Bacillus Tuberculosis).
  18. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis .
  19. Has an active infection requiring systemic therapy.
  20. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  21. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  22. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients Testing positive for any of the following infectious diseases (criteria 21-22).
  23. Evidence of the following infectious agents:
  24. Stool pathogens: Clostridium difficilie toxin B by PCR, Giardia antigen, Cryptosporidium antigen, Acid-fast stan for Cyclospora or Isospora, Ova and parasites, Helicobacterial pylori antigen positivity, Salmonella spp., Shigella spp., Campylobacter spp., Shiga-toxin producing Escherichia coli, Methicillin Resistant Staphylococcus aureus, Vancomycin Resistant Enterococcus spp., Carbapenem Resistant Enterobacteriaceae, ESBL producing E. coli, Aeromonas spp., Plesiomonas spp., Yersinia spp., Vibrio spp., Entamoeba histolytica, Rotavirus, Adenovirus, Norovirus
  25. Blood pathogens: Positive for HIV, type 1 or 2; Hepatitis A IgM; Hepatitis B antigen, anti-HBC (both IgG and IgM), and anti-HBs; Hepatitis C antigen; T. pallidum antibody; FTA-ABS (if positive T. pallidum screen)
  26. COVID-19 (unless vaccinated against COVID-19)
  27. Risk factors for contracting an illness:
  28. Ongoing high-risk behaviors (e.g. men who have sex with men, men who have sex for money, men who use intravenous drugs)
  29. Tattoo or body piercing within 6 months
  30. Risk factors for Creutzfeldt-Jakob disease
  31. Travel within the past 6 months to areas of the world where diarrheal illnesses are endemic or risk of traveler's diarrhea is high
  32. Known current communicable disease (e.g. upper respiratory infection).
  33. Gastrointestinal co-morbidities: history of inflammatory bowel disease, history of irritable bowel syndrome or idiopathic chronic constipation, history of chronic diarrhea related to inflammatory bowel disease with current diarrheal symptoms, history of gastrointestinal malignancy or known polyposis.
  34. Major immunosuppressive medications, e.g., calcineurin inhibitors, exogenous glucocorticoids, biologic agents, etc.
  35. Systemic antineoplastic agents other than enzalutamide and LHRH agonist or antagonist in the past 4 weeks.
  36. Has received a live vaccine within 30 days of planned start of study intervention. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are not allowed.

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The EXOPRO Study: How Does Prostate Cancer Metastasize? Understanding the Role of Exosomal Communication in Lean vs Obese Patients


Condition: Prostate Cancer, Obesity

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04167722

Sponsor: Imperial College London

Phase:

Eligibility:

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

Inclusion Criteria:

  • All men undergoing radical prostatectomy at Charing Cross Hospital

Exclusion Criteria:

  • Patients unable to consent

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Phase II Trial of pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer


Condition: Castration-resistant Prostate Cancer, Metastatic Cancer, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04090528

Sponsor: University of Wisconsin, Madison

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
  • Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT of abdomen/pelvis, bone scintigraphy)
  • Castrate-resistant disease, defined as follows:
  • All participants must have received (and be receiving) standard of care androgen deprivation treatment (surgical castration versus GnRH analogue or antagonist treatment); subjects receiving Gonadotropin-releasing hormone (GnRH) analogue or antagonist must continue this treatment throughout the time on this study.
  • Participants may or may not have been treated previously with a nonsteroidal antiandrogen. For participants previously treated with an antiandrogen, they must be off use of anti-androgen for at least 4 weeks (for flutamide, apalutamide, enzalutamide, or other 2nd generation AR antagonists) or 6 weeks (for bicalutamide or nilutamide) prior to registration. Moreover, participants who demonstrate an anti-androgen withdrawal response, defined as a > 25% decline in PSA within 4-6 week of stopping a nonsteroidal antiandrogen, are not eligible until the PSA rises above the nadir observed after antiandrogen withdrawal.
  • Participants must have a castrate serum level of testosterone (< 50 ng/dL) within 6 weeks of day 1
  • Progressive disease while receiving androgen deprivation therapy defined by any one of the following as per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) bone scan criteria or RECIST 1.1 during or after completing last therapy:
  • PSA: At least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, with the final value > 2.0 ng/mL.
  • Measurable disease: > 50% increase in the sum of the cross products of all measurable lesions or the development of new measurable lesions. The short axis of a target lymph node must be at least 15 mm by spiral CT to be considered a target lesion
  • Non-measurable (bone) disease: The appearance of two or more new areas of uptake on bone scan (or Sodium Fluoride (NaF) positron emission tomography-computed tomography (PET/CT)) consistent with metastatic disease compared to previous imaging during castration therapy. The increased uptake of pre-existing lesions on bone scan will not be taken to constitute progression, and ambiguous results must be confirmed by other imaging modalities (e.g. X-ray, CT or MRI).
  • Prior treatment with abiraterone or enzalutamide is permitted, but participants must have weaned to a daily corticosteroid dose equivalent of no more than 5 mg prednisone daily for at least 28 days prior to day 1.
  • Life expectancy of at least 6 months
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Adequate hematologic, renal, liver, and coagulation function as evidenced by the following within 6 weeks of day 1:
  • White Blood Cells (WBC) >/= 2000 / mm3
  • Absolute Neutrophil Count (ANC) >/= 1500 / mm3
  • Hemoglobin (HgB) >/= 9.0 gm/dL (Participants must not have received a blood transfusion within 14 days)
  • Platelets >/= 100,000 / mm3
  • Creatinine
  • Total bilirubin 1.5 x ULN
  • Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT)
  • Prothrombin Time (PT) or International Normalized Ratio (INR)
  • Partial Thromboplastin Time (PTT)
  • No known history of human immunodeficiency viruses (HIV 1 and 2), Human T-cell leukemia virus type 1 (HTLV-1), or active Hepatitis B or Hepatitis C
  • Participants must be at least 4 weeks from any prior treatments and have recovered (to < Grade 2) from acute toxicity attributed to this prior treatment, unless considered chronic
  • A subset of participants (6 participants per treatment arm) treated at the lead University of Wisconsin (UW) site must be willing and able (in the opinion of the treating physician) to undergo two research biopsies for the investigational component of this trial.
  • A subset of participants (6 participants per treatment arm) treated at the lead UW site must be willing to undergo NaF PET/CT scans for the investigational component of this trial.
  • For those participants who are sexually active, they must be willing to use barrier contraceptive methods, and refrain from donating sperm, during the period of treatment on this trial and for four weeks after the last DNA immunization treatment
  • Participants must be informed of the experimental nature of the study and its potential risks, and must sign an Institutional Review Board (IRB)-approved written informed consent form indicating such an understanding

Exclusion Criteria:

  • Small cell or other variant (non-adenocarcinoma) prostate cancer histology, unless there is evidence that the tumor expresses PAP
  • Participants may not be receiving other investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy
  • Concurrent bisphosphonate therapy is not excluded, however participants should not start bisphosphonate therapy while on this study; those participants already receiving bisphosphonate therapy should continue at the same dosing and schedule as prior to study entry
  • Rapidly progressive symptomatic metastatic disease, as defined by the need for increased opioid analgesics within one month of registration for the treatment of pain attributed to a prostate cancer metastatic lesion; participants receiving opioids must receive approval from the PI for eligibility
  • Treatment with any of the following medications within 28 days of day 1, or while on study, is prohibited:
  • Systemic corticosteroids (at doses over the equivalent of 5 mg prednisone daily); inhaled, intranasal or topical corticosteroids are acceptable
  • Prostate Cancer and spes (PC-SPES)
  • Megestrol
  • Ketoconazole
  • 5-α-reductase inhibitors
  • participants already taking 5-α-reductase inhibitors prior to 28 days prior to registration may stay on these agents throughout the course of therapy, but these should not be started while participants are on study
  • Diethyl stilbesterol
  • Abiraterone
  • Enzalutamide
  • Apalutamide
  • Radium 223 (Xofigo®)
  • Any other hormonal agent or supplement being used with the intent of cancer treatment must be reviewed by the PI for eligibility
  • External beam radiation therapy within 4 weeks of registration is prohibited, or anticipated need for radiation therapy (e.g. imminent pathological fracture or spinal cord compression) within 3 months of registration. Participants must have recovered from all radiation-related toxicities and not have had radiation pneumonitis.
  • Major surgery within 4 weeks of registration is prohibited
  • Prior cytotoxic chemotherapy (for example, but not limited to, docetaxel, mitoxantrone, cabazitaxel) within 28 days of registration is prohibited
  • Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with any agent directed to another T-cell stimulatory or inhibitory receptor (e.g. CTLA-4, OX-40, CD137).
  • Participants with a history of life-threatening autoimmune disease
  • Participants with a history of non-infectious pneumonitis that required corticosteroid treatment, or has current pneumonitis
  • Participants with a history of allergic reactions to the tetanus vaccine
  • Participants who have undergone splenectomy or who have a diagnosis of immunodeficiency
  • Participants must not have other active malignancies other than non-melanoma skin cancers or superficial (non-muscle-invasive) carcinoma of the bladder. Participants with a history of other cancers who have been adequately treated and have been recurrence-free for > 3 years are eligible.
  • Participants with known brain metastases and/or carcinomatous meningitis
  • Participants who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette
  • Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
  • Any antibiotic therapy within 1 month of day 1, or anticipated need for antibiotic therapy within 1 month of beginning treatment
  • Participants with active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Any other medical intervention or condition, which, in the opinion of the PI or treating physician, could compromise participant safety or adherence with the study requirements (including biopsies), or confound results of the study, over the treatment period.
  • Any known psychiatric or substance abuse disorders that would interfere with cooperation with the requirement of the trial.
  • Participants cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies.

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Reducing Prostate Cancer Disparities Among African Americans


Condition: Cancer Survivor, Partner, Spouse, 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, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04215029

Sponsor: M.D. Anderson Cancer Center

Eligibility:

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

Inclusion Criteria:

  • To be eligible, prostate cancer survivors must self-identify as black or African American
  • Prostate cancer survivors must have 0-III stage prostate cancer
  • Prostate cancer survivors must have completed therapy (e.g., surgery, chemotherapy [chemo] and/or radiation)
  • Prostate cancer survivors must enroll with a spouse or a romantic partner
  • Prostate cancer survivors must not meet physical activity recommendation (i.e., 150 minutes of moderate intensity physical activity per week)
  • Prostate cancer survivors must be willing and able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q)
  • Prostate cancer survivors must not participate in another physical activity, diet, or lifestyle program
  • Prostate cancer survivors must have a valid home address and telephone number
  • Prostate cancer survivors must be able to access internet over a smartphone or a computer at home or other location (e.g., work, church, library, community center, etc.)
  • To be eligible, spouses or romantic partners must be >=18 years of age
  • Spouses or romantic partners must enroll with a spouse or a romantic partner with prostate cancer
  • Spouses or romantic partners must live together with the survivors
  • Spouses or romantic partners must not have major health problems (e.g., cancer, dementia, stroke, and heart and lung diseases)
  • Spouses or romantic partners must be willing and able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q)
  • To be eligible, healthcare providers must be currently providing care with individuals diagnosed with prostate cancer
  • Any professionals such as surgical and medical oncologists, fellows, nurse practitioners, physical assistants, and primary care physicians will be eligible Exclusion Criteria:
  • Prostate cancer survivors will be excluded if they are not married or partnered
  • Prostate cancer survivors will be excluded if they have an active noncutaneous malignancy at any site
  • Prostate cancer survivors will be excluded if they had a prior history of other cancer or have metastatic cancer
  • Prostate cancer survivors will be excluded if they have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period
  • Prostate cancer survivors will be excluded if they are on active surveillance
  • Prostate cancer survivors will be excluded if they enrolled in a protocol #: 2017-0556
  • Prostate cancer survivors will be excluded if they are not able to understand and speak English
  • Spouses or romantic partners who are not able to understand and speak English will be excluded
  • Also, spouses or romantic partners who enrolled in a protocol (#2017-0556) will be excluded
  • There are no

Exclusion Criteria:

  • Prostate cancer survivors will be excluded if they are not married or partnered
  • Prostate cancer survivors will be excluded if they have an active noncutaneous malignancy at any site
  • Prostate cancer survivors will be excluded if they had a prior history of other cancer or have metastatic cancer
  • Prostate cancer survivors will be excluded if they have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period
  • Prostate cancer survivors will be excluded if they are on active surveillance
  • Prostate cancer survivors will be excluded if they enrolled in a protocol #: 2017-0556
  • Prostate cancer survivors will be excluded if they are not able to understand and speak English
  • Spouses or romantic partners who are not able to understand and speak English will be excluded
  • Also, spouses or romantic partners who enrolled in a protocol (#2017-0556) will be excluded
  • There are no exclusion criteria for healthcare providers

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An Exploratory proof-of Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients, a Single Center Study


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03408964

Sponsor: Andrea Alimonti

Phase:

Eligibility:

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

Inclusion Criteria:

  • General inclusion criteria (for entering all groups)
  • Age ≥ 18 years
  • Histological diagnosis of prostate adenocarcinoma at different stages of disease (see Section 6.2) for which a treatment is indicated
  • Written Informed Consent Inclusion criterion only for entering Group 0 • Patients with a known diagnosis of CSPC or CRPC Inclusion criterion only for entering Group 1a • Patients that underwent biopsies for a suspect of PC, but resulted negative for cancer Exclusion Criteria: General exclusion criteria (for entering all groups)
  • Active infection requiring treatment
  • Decrease of general condition
  • Concomitant severe comorbities
  • Difficult socioeconomic conditions making regular follow up unfeasible.
  • Need of concomitant steroids at study entry and during the study
  • Diagnosis of second tumor in the previous 5 years Exclusion criterion only for entering Group 0 • No antibiotic treatments in the previous 2 months before enrollment Exclusion criteria only for entering Group 1
  • Previous radical surgery and / or radical radiotherapy
  • Previous hormonal treatments

Exclusion Criteria:

  • General exclusion criteria (for entering all groups)
  • Active infection requiring treatment
  • Decrease of general condition
  • Concomitant severe comorbities
  • Difficult socioeconomic conditions making regular follow up unfeasible.
  • Need of concomitant steroids at study entry and during the study
  • Diagnosis of second tumor in the previous 5 years Exclusion criterion only for entering Group 0 • No antibiotic treatments in the previous 2 months before enrollment Exclusion criteria only for entering Group 1
  • Previous radical surgery and / or radical radiotherapy
  • Previous hormonal treatments Exclusion criteria only for entering Group 2
  • No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics)
  • Previous hormonal treatments for advanced disease Exclusion criterion only for entering Group 3 • No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics analyses)

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Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry


Condition: Neoplasms Prostate, Cancer of the Prostate

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT02381990

Sponsor: Urological Research Network, LLC

Phase:

Eligibility:

  • Age: minimum 55 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Men between 55 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and <50% positive core rate by prostate lobe
  • Men older than 65 years of age with clinical diagnosis of prostate cancer <50% positive core rate by prostate lobe
  • Absence of extra-capsular extension
  • Absence of seminal vesicle invasion
  • Absence of regional or distant metastatic disease
  • Multiparametric MRI of the prostate performed either before the biopsy or >10 weeks after prostate biopsy
  • Treated with Cryotherapy of the prostate
  • Treatment based on co-registration between MP-MRI and Prostate Ultrasound

Exclusion Criteria:

  • Prior treatment of prostate cancer in the form of surgery.
  • Performance status greater than 0 based on ECOG criteria
  • Mental status impairment

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Using Breath,Cell Free DNA and Image Analysis to PRedIct Normal TissUe and Tumour Response During Prostate Cancer SBRT With RayPilot® Motion Management


Condition: Prostate Cancer, Radiotherapy Side Effects, Volatile Organic Compounds, DNA Damage

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04081428

Sponsor: NHS Lothian

Phase:

Eligibility:

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

Inclusion Criteria:

  • Low risk prostate cancer T1-2, PSA<10ng/ml, Gleason score (GS) 3+3=6
  • Intermediate risk prostate cancer T1-T2, PSA 10-20ng/ml,GS ≤7(3+4=7 only)
  • World Health Organisation (WHO) performance status 0-2
  • Prostate volume ≤90cc
  • International Prostate Symptom Score (IPSS) ≤20
  • Peak urinary flow rate (Q-max) >10cc/sec
  • Urinary residual <250mls total
  • No prior Trans Urethral Resection of the Prostate (TURP)
  • No previous pelvic radiotherapy
  • Able to give informed consent
  • Aged between 18-85 years of age

Exclusion Criteria:

  • Inflammatory bowel disease
  • Previous androgen deprivation therapy
  • History of urinary retention

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Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)


Condition: Prostate Cancer, PSA, Infection

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04081636

Sponsor: Albany Medical College

Eligibility:

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

Inclusion Criteria:

  • All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care
  • Either with or without an MRI

Exclusion Criteria:

  • Patients with no access to rectum (due to previous rectal surgery)
  • Any abnormalities of the perineal skin (e.g. infection)
  • Patients whose procedure requires sedation or general anesthesia

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Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04083937

Sponsor: University Hospital Heidelberg

Eligibility:

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

Inclusion Criteria:

  • histology-proven prostate cancer with Gleason Score and PSA-value;
  • indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy;
  • Karnofsky-Index ≥ 70%
  • age ≥ 18 years

Exclusion Criteria:

  • androgen deprivation therapy
  • lymphatic spread
  • macroscopic tumor/ R2
  • stage IV (M1)
  • previous irradiation

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Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study


Condition: Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04175431

Sponsor: University of Washington

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Patient must have histologically or cytologically documented evidence of prostate adenocarcinoma
  • Patient must previously have undergone radical prostatectomy
  • Patient must previously have undergone either adjuvant or salvage radiation therapy to the prostatic fossa +/- whole pelvis
  • Patient must have a prostate specific antigen (PSA) >= 0.2 and < 10 ng/mL. If there is only one PSA value that has risen to >= 0.2 with this biochemical recurrence, a second PSA value must be confirmed to be within >= 0.2 and < 10 ng/mL at least 2 weeks from the first value and within 28 days of enrollment
  • PSA doubling time must be calculated utilizing either all PSA measurements > 0.1 ng/mL from most recent biochemically-recurred (BCR) or the most recent 3 PSA measurements > 0.1 ng/mL (if the latter, all 3 PSA measurements must be > 2 weeks apart to be used in the calculation). PSA doubling time must be > 3 months and < 18 months. The Memorial Sloan Kettering PSA doubling time calculator should be used
  • Patient must have no previous evidence of radiographically detectable metastatic prostate cancer by conventional CT and bone scan imaging
  • Patient must have total testosterone level > 120 ng/dL demonstrated within 42 days of enrollment
  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Absolute neutrophil count (ANC) >= 1.0 X 10^9/L
  • Platelet count >= 100 X 10^9/L
  • Hemoglobin >= 9 g/dL
  • Potassium >= 3.5
  • Serum bilirubin =< 1.5 X upper limit of normal (ULN) or =< 3 X ULN for patients with documented Gilbert's syndrome
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 X ULN
  • Creatinine clearance (Cr Cl) >= 30 mL/min as estimated by the Cockcroft-Gault criteria or as determined by 24 hour Cr Cl measurement
  • Patient must be >= 18 years of age on day of signing informed consent
  • Patient must be able to understand and authorize informed consent

Exclusion Criteria:

  • Chronic active hepatitis B or C
  • History of a second, non-prostate malignancy that required systemic therapy in the last 2 years except cancer in situ of bladder and non-melanomatous cancers of the skin
  • Patient with a serious underlying medical condition that would otherwise impair the patient's ability to undergo fluciclovine or PSMA PET/CT imaging or receive subsequent treatment
  • Any condition that would alter the patient's mental status, prohibiting understanding and/or authorization of informed consent
  • Expected lifespan of less than 12 weeks
  • Inability to lay still for imaging
  • Weight > 300 lbs. (due to equipment specifications)
  • Any other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and/or follow up

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A Feasibility Study of Hypoxia Imaging in Patients With Prostate Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01567800

Sponsor: University Health Network, Toronto

Eligibility:

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

Inclusion Criteria:

  • Age => 18 years
  • Histologic diagnosis of adenocarcinoma of the prostate
  • Bulky intermediate risk, high risk or metastatic prostate cancer Bulky intermediate risk: cT1-2 with >50% of diagnostic biopsy cores containing cancer and Gleason 6 or 7 and prostate specific antigen (PSA) >10 and ≤20 OR High risk: cT1-2 with Gleason score ≥8; or cT1-2 with PSA >20; or cT3 OR N+ and/or M1 disease OR Newly diagnosed hormone-refractory prostate cancer
  • Intention to treat using radiotherapy +/- concurrent and adjuvant hormonal therapy
  • Intention to treat with radiotherapy, hormonal therapy, other systemic treatment for prostate cancer, or a combination of these according to the Princess Margaret Genitourinary Site policies.
  • Previous or concurrent anti-cancer therapy for the PET FAZA target lesion allowed
  • Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  • Inability to lie supine for more than 60 minutes
  • Patients taking the drug disulfiram (Antabuse)
  • Contraindications for MRI: only applicable in cases where the PET FAZA target lesion is identified as the prostate gland. Patients with target lesions at other anatomic sites will not undergo MR imaging.
  • Patients weighing > 136 kg

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PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer


Condition: Prostate Cancer, Prostate Neoplasm

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03232164

Sponsor: University of Wisconsin, Madison

Phase: Early Phase 1

Eligibility:

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

Inclusion Criteria:

  • Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for Sub-Study 1 and 4)
  • Prostate biopsy histology grade ≥ Gleason 1, 6, 3+4, or 4+3; positive biopsy >2 cores
  • Any PSA permitted
  • Two consecutive rising PSA values (Sub-Study 3 only)
  • Castrate-levels of testosterone
  • total testosterone < 50 ng/dL (Sub-Study 3 only)
  • Patients considered as candidates for and medically fit to undergo prostatectomy
  • At least 7 days after most recent prostate biopsy
  • Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities (Sub-Study 3 only)
  • New diagnosis of prostate cancer undergoing additional biopsy evaluation (Sub--Study 4 only)
  • Karnofsky performance status of at least 70 (Sub-Study 4 only)
  • General health and anatomy suitable to undergo transrectal ultrasound-MRI fusion biopsy of the identified lesions and standard 12 core sextent biopsy (Sub-Study 4 only)

Exclusion Criteria:

  • Prior pelvic external beam radiation therapy or brachytherapy
  • Chemotherapy for prostate cancer
  • Androgen deprivation therapy for prostate cancer
  • Investigational therapy for prostate cancer (Sub-Study 3 Only)
  • Unable to lie flat during or tolerate PET/CT
  • Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
  • No prostatectomy scheduled more than 12 hours post imaging (Sub-Study 1 only)
  • Serum creatinine > 2 time the upper limit of normal
  • Total bilirubin > 3 times the upper limit of normal
  • Liver Transaminases > 5 times the upper limit of normal

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The BARCODE 2 Study - The Use of Genetic Profiling to Guide Prostate Cancer Treatment


Condition: Hormone Refractory Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02955082

Sponsor: Institute of Cancer Research, United Kingdom

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. All study participants will be assessed according to the part 1 and/ or part 2 inclusion criteria depending on which part of the study they enter initially. For Part 1 (genetic screening) of the study:
  2. Age ≥ 18 years.
  3. Recorded diagnosis of prostate cancer with or without histological confirmation. Patients who have not previously undergone a prostate (or metastatic) biopsy but are confirmed to have a raised PSA (>80ng/ml at any time), metastatic disease on imaging and have undergone treatment for mCRPC are eligible.
  4. Castration-resistant disease defined as biochemical or radiological progression on/after treatment with orchidectomy or LHRH analogues as per PCWG3 criteria.
  5. Confirmed metastatic disease on conventional imaging methods such as CT, bone scan or PET imaging.
  6. Current or previous treatment includes at least one of the following:
  7. Docetaxel (either in hormone sensitive or resistant setting; Patients who have completed treatment with or are currently undergoing Cabazitaxel chemotherapy are also eligible)
  8. Androgen receptor-directed therapy (e.g., Enzalutamide, Abiraterone)
  9. Adequate renal function measured by calculated GFR (Cockcroft-Gault) >30ml/min. If a participant had renal dysfunction that is expected to improve, they may be considered for part 1 of the study.
  10. Adequate haematological function to allow study entry in line with local hospital practice or at the investigator's discretion.
  11. WHO performance status 0-2 as assessed and documented by study doctor.
  12. Life expectancy >12 weeks
  13. Participants with stable, treated brain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present
  14. The subject is capable of understanding and complying with the protocol requirements and has signed the BARCODE 2 informed consent form. In addition to the above, for Part 2 of the study:
  15. Confirmed pathogenic germline mutation in a DNA repair gene. (Participants with a known germline mutation will need to provide a report from the external laboratory where genetic testing was carried out)
  16. Previous treatment with docetaxel and androgen receptor-directed therapy (e.g., abiraterone or enzalutamide) with documented disease progression prior to entry to part 2 (rising PSA and/or radiographic progression). Patients previously treated with cabazitaxel and who have documented disease progression are also eligible.
  17. Adequate haematological function: Haemoglobin (Hb) ≥8.0g/dL, neutrophil count ≥1.5x109/L and platelets ≥100x109/L.
  18. Adequate liver function: Total bilirubin ≤1.5 x upper limit of normal (ULN) except for participants with known Gilbert's syndrome; AST and ALT ≤ 2.5x ULN in the presence of liver metastases.
  19. Adequate renal function: creatinine clearance >30ml/min measured by a glomerular filtration rate (GFR) clearance test. If a measured GFR test is not available, then calculated GFR is acceptable (measured GFR must be carried out by cycle 2 of carboplatin).

Exclusion Criteria:

  1. (for part 1 and 2):
  2. Critical organ metastases (e.g. spinal metastases with risk of cord compression) as documented on most recent imaging report.
  3. Participants with bleeding tumours.
  4. Previous treatment with a platinum chemotherapy drug for prostate cancer.
  5. Previous treatment with a PARP inhibitor
  6. Participants with a history of severe allergic reaction to carboplatin or other platinum-containing compounds
  7. Exposure to yellow fever vaccine in the previous 6 months.
  8. Participants unfit for chemotherapy or those with ongoing neuropathy >grade 1 (sensory or motor) according to NCI CTCAE V4.
  9. Known and documented hearing impairment
  10. Other active malignancies or previous malignancies likely, in the PI's opinion, to impact on management of mCRPC.
  11. Significant documented cardiovascular disease: severe/unstable angina, myocardial infarction less than 6 months prior to trial entry, arterial thrombotic events less than 6 months prior to trial entry, clinically significant cardiac failure requiring treatment (NYHA II-IV).
  12. Cerebrovascular disease (CVA or TIA) in the preceding 2 years to entry to Part 2 of study.
  13. Presence of symptomatic brain metastases.

View trial on ClinicalTrials.gov


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