Prostate Cancer

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Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate


Condition: Locally Recurrent Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03073278

Sponsor: Royal North Shore Hospital

Eligibility:

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

Inclusion Criteria:

  • Men > 4yrs from external beam radiotherapy (EBRT) meeting the Phoenix definition of biochemical failure or men > 5yrs from EBRT if neo-adjuvant and/or adjuvant androgen deprivation therapy (ADT) also used
  • Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric MRI (less than equal to cT2a)
  • Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI suspicious region.
  • Life expectancy at least 10yrs from time of SBRT
  • PSA < 10

Exclusion Criteria:

  • Recurrence in immediate proximity to rectum (unless able to have hydrogel)
  • Grade 3 or more toxicity from previous EBRT
  • Contra-indicated for fiducial insertion
  • GS 8,9 or 10 disease previously (relative
  • consider if decent disease free interval)

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Phase I Study of In Situ Autologous Vaccination Against Prostate Cancer With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Prior To Radical Prostatectomy


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03262103

Sponsor: Ashutosh Kumar Tewari

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • 1. Written informed consent and HIPAA authorization for release of personal health information. 2. Age > 18 years at the time of consent. 3. ECOG Performance Status of 0-1 within 14 days prior to being registered for protocol therapy (Study Procedure Manual). 4. Histologically confirmed adenocarcinoma of the prostate (with previous diagnostic tissue available for tumor marker analysis). 5. Gleason 7
  • 10, cT2a
  • cT3b adenocarcinoma of the prostate with plans for radical prostatectomy 6. PSA ≥ 4 ng/ml 7. Tumor visible on multiparametric MRI 8. Tolerated previous transrectal ultrasound guided biopsy procedure under local anesthetic a. Uncomplicated previous TRUS biopsy procedure (i.e., no prior hospitalization due to sepsis, prostatic abscess or severe hemorrhage following TRUS prostate biopsy) 9. Willing to undergo the intra-tumoral (IT) injection of the Poly-ICLC into the prostatic tumor as per the protocol 10. No prior hormonal therapy with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Patients who have received prior oral anti-androgen therapies (bicalutamide, flutamide, nilutamide, etc.) must be off treatment for at least 6 weeks prior to enrollment. Patients who have received prior LHRH agonist or antagonist therapy (leuprolide, goserelin acetate, etc.) are eligible provided serum testosterone is > 50 mg/dl. 11. No prior radiation therapy (external beam or brachytherapy) to the pelvis or prostate. 12. No clinically significant infections as judged by the treating investigator. 13. No characteristics suggesting a potential higher risk of infection with intraprostatic injections: 1. Recurrent urinary tract infections or history of prostatitis within 3 months prior to enrollment into the study. 2. Urine analysis positive for nitrites and leucocyte esterase. Such patients could be considered for the study after treatment and resolution of the infection. 3. Active proctitis 4. History of prostatic abscess 5. Taking immunosuppressive medication including systemic corticosteroids 6. Active hematologic malignancy 14. No uncontrolled angina, congestive heart failure or MI within 6 months. 15. Patients with history of HIV (if CD4+ T cell counts are ≥350 cells/µL on established ART therapy), Hepatitis B (with viral load below limits of quantification) or Hepatitis C (who have completed a curative therapy and have a viral load below the limit of quantification) are eligible for this study. 16. No treatment with any investigational agent for any medical condition within 28 days prior to being registered for protocol therapy. 17. Adequate end organ function as determined by the following laboratory values:
  • White blood cell count (WBC) > 2.5 k/mm3
  • Absolute neutrophil count (ANC) > 1.5 k/mm3
  • Hemoglobin (Hgb) > 8.0 g/dL
  • Platelets > 100 k/mm3
  • Calculated creatinine clearance of > 60 cc/min using the Cockcroft-Gault formula: Males: (140
  • Age in years) × Actual Body Weight in kg 72 × Serum Creatinine (mg/dL)
  • Bilirubin < 2.0 x ULN
  • Aspartate aminotransferase (AST) < 2.5 x ULN
  • Alanine aminotransferase (ALT) < 2.5 x ULN 18. Able to speak, read and write in English.

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INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4): A Multicentre, Randomised, Controlled, Phase III Study


Condition: Metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02730338

Sponsor: Movember Foundation

Eligibility:

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

Inclusion Criteria:

  • mCRPC status:
  • mCRPC patients defined as; adenocarcinoma of the prostate with systemic metastatic disease despite castrate levels of testosterone (<50 ng/dL) due to orchiectomy or LHRH agonist. o Patients must have one or more of the following to be considered mCRPC
  • Metastatic Disease Progression: >20% increase in the sum of diameters of measurable lesions from the time of maximal regression or appearance of one or more new lesions.
  • Bone Scan Progression: Appearance of one or more new lesions on bone scan attributable to prostate cancer.
  • PSA Progression: PSA ≥2 ng/ml that has risen serially on at least two occasions, each at least one week apart (PSA1 < PSA2 < PSA3).
  • PSMA PET/CT scan progression: Appearance of one or more new lesions on PSMA PET/CT scan attributable to prostate cancer.
  • At enrolment, mCRPC patients must fit into one of the following 5 categories: 1. Treatment naïve for mCRPC (have not yet started approved therapies for CRPC ie: Abiraterone/Enzalutamide/Apalutamide / or Docetaxel, Cabazitaxel or other approved first line chemotherapy; less than 4 weeks on approved therapies is still considered to be treatment naïve) Or 2. Receiving Abi/Enza/Apa for mCRPC AND responding or stable (PSA values must be stable or declining after at least 4 weeks since starting Abi/Enza/Apa for mCRPC) Or 3. Patients with PSA progression while on Abi/Enza/Apa are eligible as long as they are asymptomatic AND there is no intent on starting chemotherapy within 6 months Or 4. Patients treated with Docetaxel, Cabazitaxel or other approved first line chemotherapy as first line for mCRPC who are asymptomatic without ANY evidence of progression Or 5. Patients may have progressed following first line Docetaxel, Cabazitaxel or other first line chemotherapy and are now receiving treatment with Abi/Enza/Apa. These patients must absolutely be responding or stable (PSA values must be stable or declining after starting Abi/Enza/Apa treatment) and have an estimated life expectancy of more than 1 year. mHSPC Status:
  • mHSPC patients must be classified as either high-risk or high-volume mHSPC. These groups are defined as adenocarcinoma of the prostate with systemic metastatic disease and patients also fit into one of the following 2 categories: 6. High-risk: defined as having at least 2 of three criteria: (i) Gleason score ≥8, (ii) presence of ≥3 lesions on bone scan, or (iii) presence of INTERVAL Protocol Version 5.0, 19 August 2019 4 measurable visceral lesions (PSMA PET imaging should not be used in the definition of high-risk disease) Or 7. High-volume: defined as having the presence of visceral metastases and/or ≥ four bone metastases with at least one outside of the vertebral column and pelvis (PSMA PET imaging should not be used in the definition of high-volume disease) Additional criteria for all groups:
  • All patients will be required to be on ADT during the study period or have had a prior bilateral orchiectomy.
  • Men with small cell neuroendocrine tumours or features of small cell disease are not eligible.
  • ≥4 weeks since last major surgery and fully recovered.
  • No known contraindications to high intensity exercise, including, but not limited to: brain metastases; current congestive heart failure (New York Heart Association Class II, III or IV); serious or non-healing wound, ulcer, or bone fracture; spinal cord compromise or instrumentation due to metastatic disease; peripheral neuropathy ≥grade 3. No serious cardiovascular events within 12 months including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI). Patients with a history of hypertension must be well-controlled (< 160/90) on anti-hypertensive therapy.
  • Halabi Nomogram score <1951 (Risk Category rated as low or intermediate risk)
  • Age ≥18 years
  • Required Baseline Laboratory Values: ANC ≥ 1500/uL; Platelet count ≥ 100,000/uL; Creatinine ≤ 1.5 x upper limits of normal; Bilirubin ≤ 1.5 x upper limits of normal; AST ≤ 1.5 x upper limits of normal; Serum testosterone ≤ 50 ng/dL
  • ECOG performance status 0-1
  • Medical clearance by treating physician to undergo a symptom-limited cardiopulmonary exercise test and vigorous aerobic and resistance exercise training, and able to complete an acceptable cardiopulmonary exercise test.
  • Exercise Coordination Centre (ECC) review and approval of subject's screening bone scan / areas with bone metastases.
  • Men participating in vigorous aerobic exercise for >60 min/week or structured resistance exercise ≥2 days/week, are not eligible.
  • Subject is willing and able to use technological aspects of the trial.
  • The subject is fluent in the language as designated by the institution at which he would be enrolled.

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Fluorine-18 - 2-(3-(1-carboxy-5-[(6-[18F]Fluoro-pyridine-3-carbonyl)-Amino]-Pentyl)-Ureido)-Pentanedioic Acid (18F-DCFPyL) Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of Recurrent Prostate Cancer


Condition: Prostatic Neoplasms, Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02899312

Sponsor: British Columbia Cancer Agency

Phase:

Eligibility:

  • Age: minimum 19 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Known PC with a biochemical recurrence (BR) after initial curative therapy with radical prostatectomy, with a documented history of failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increased on 2 or more determinations (PSA recurrence). The patient may have received treatment following documentation of PSA persistence or PSA recurrence. The most recent PSA measurement must be greater than 0.4 ng/mL.
  • Participants with findings on other examinations (such as plain x-ray, CT, MRI or bone scintigraphy and others) that are suspicious for metastatic disease but not conclusively diagnostic of metastatic disease.
  • Known PC with BR after initial curative therapy with radiation therapy (including brachytherapy), with a PSA level >2 ng/mL above the nadir after radiation therapy.
  • Castration resistant PC with a minimum PSA of 2.0 ng/mL with 2 consecutive rises above the nadir and castrate levels of testosterone (<1.7 nmol/L). Treatment does not need to be discontinued before the 18F-DCFPyL scan.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.

Exclusion Criteria:

  • Medically unstable (eg. acute illness, unstable vital signs)
  • Unable to lie supine for the duration of imaging
  • Unable to provide written consent
  • Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)

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Hereditary Leiomyomatosis Renal Cell Cancer (HLRCC): Identification of the Disease Gene, and Characterization of the Predisposition to Renal Cancer


Condition: Renal Tumor Histology, Cutaneous Leiomyoma, Kidney Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00050752

Sponsor: National Cancer Institute (NCI)

Phase:

Eligibility:

  • Age: minimum 2 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Patients suspected or known to have phenotype or genotype suggestive of Hereditary Leiomyomatosis and Renal Cell Cancer Syndrome (HLRCC), such as:
  • Cutaneous leiomyoma and kidney cancer
  • Cutaneous leiomyoma and uterine leiomyoma
  • Multiple cutaneous leiomyoma
  • Kidney cancer and uterine leiomyomata
  • Renal tumor histology consistent with HRLRCC including, but not limited to: Collecting Duct and/or Papillary, Type II
  • All patients and parents/guardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed. Patients under the age of 18 but who are age 13 or older will be asked to sign an assent document prior to participation.
  • Participants must be (Bullet) 2 years of age.
  • A relative (related by blood) of a patient with a confirmed or suspected diagnosis of HLRCC.

Exclusion Criteria:

  1. -Pregnant women are excluded from enrollment onto this study because there is no direct benefit for participating in the study.

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Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases


Condition: Malignant Neoplasms, Hereditary Neoplastic Syndromes, Kidney Cancer, Renal Cancer, Bladder Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00026884

Sponsor: National Cancer Institute (NCI)

Phase:

Eligibility:

  • Age: minimum 2 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Adult and minor patients with biopsy-proven malignant disease
  • Adult and minor patients suspected of having a malignant disease
  • Patients who have or are suspected of having an inherited genitourinary malignant disorder
  • Participants must be >= 2 years of age
  • Family members (related by blood) of patients who have or are suspected of having a malignant disease or an inherited genitourinary malignant disorder
  • All patients and guardians, for adults unable to consent or children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed. Patients under the age of 18 but who are age 13 or older will be asked to sign an assent document prior to participation.

Exclusion Criteria:

  • Subjects whose co-morbidities preclude surgical intervention.

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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

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A Phase II Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial


Condition: Prostate Cancer, Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01411345

Sponsor: University of Miami

Phase: Phase 2/Phase 3

Eligibility:

  • Age: minimum 35 Years maximum 85 Years
  • Gender: Male

Inclusion Criteria:

  1. Prostate cancer patients with a PSA after prostatectomy of at least 0.1 ng/mL and up to 4.0 ng/mL within 3 months prior to enrollment.
  2. Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible.
  3. Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing.
  4. Imaging detectable lesion or lesions in prostate bed or regional lymph node (LN). Each lesion should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months prior to protocol entry or enrollment.
  5. No evidence of metastatic (distant) disease (pelvic nodes are allowed up to common iliac).
  6. Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to protocol entry or enrollment.
  7. No previous pelvic radiotherapy.
  8. Serum total testosterone taken within 3 months prior to enrollment.
  9. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 3 years then the patient is eligible.
  10. Ability to understand and the willingness to sign a written informed consent document.
  11. Zubrod performance status <
  12. Patients must agree to fill out quality of life/psychosocial questionnaires.
  13. Age ≥ 35 and ≤ 85 years.

Exclusion Criteria:

  1. a. Prior androgen deprivation therapy is not permitted if it was within 6 months previous to signing consent form. (NOTE: Therapy given as part of the planned course of radiation is allowed).

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Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00969111

Sponsor: Proton Collaborative Group

Eligibility:

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

Inclusion Criteria:

  • Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
  • Maximum PSA value of 20 ng/ml.

Exclusion Criteria:

  • Evidence of distant metastasis (M1).
  • Prior systemic chemotherapy for any reason.
  • Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
  • History of hip replacement.
  • Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

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A Randomized Trial of Modifications to Radical Prostatectomy


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01407263

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Patients do not have to be eligible for both modifications to be included in the study. Lymphadenectomy vs no lymphadenectomy:
  • Patients 21 years or older scheduled for radical prostatectomy for treatment of prostate cancer with one of the consenting surgeons at MSKCC

Exclusion Criteria:

  • Lymphadenectomy vs no lymphadenectomy
  • Presence of positive/suspicious pelvic nodes on MRI, CT or PSMA scan (positive/suspicious defined as a pelvic node >15mm in short axis or a node with abnormal morphology such as roundness or irregularity or loss of fatty hilum
  • Any prior pelvic radiation therapy used to treat prostate cancer

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Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Analysis of Genetic Differences in Drug Disposition


Condition: Prostate Cancer, Breast Cancer, Lung Cancer, Ovarian Cancer, Lymphoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01441089

Sponsor: National Cancer Institute (NCI)

Phase:

Eligibility:

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

Inclusion Criteria:

  1. Patients with cancer, other tumors, or tumor predisposition syndromes currently enrolled in NIH intramural research program therapeutic trials . Ability of patient to understand and be willing to sign the informed consent document. Must be greater than or equal to

Exclusion Criteria:

  1. N/A

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Biospecimen Acquisition From Human Subjects


Condition: Prostate Cancer, Breast Cancer, Colon Cancer, Lung Cancer, Liver Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00034216

Sponsor: National Cancer Institute (NCI)

Phase:

Eligibility:

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

Inclusion Criteria:

  1. Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible. Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol. Ability to understand and the willingness to sign a written informed consent document. INCLUSION FOR APHERESIS: Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference. Hemoglobin greater than or equal to 10 mg/dL and platelet count > 75,000/mm(3) Weight greater than 25 kg HIV negative Prothrombin Time within normal limits Partial Thromboplastin Time within normal limits Medically indicated central line in place or adequate peripheral venous access

Exclusion Criteria:

  1. Children will not be eligible.

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Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer


Condition: Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02739659

Sponsor: Shanghai Proton and Heavy Ion Center

Eligibility:

  • Age: minimum 20 Years maximum 85 Years
  • Gender: Male

Inclusion Criteria:

  • Pathologically confirmed adenocarcinoma of the prostate
  • No lymph node and distant metastasis
  • Age ≥ 20 and < 85 years of age
  • Karnofsky Performance Score ≥70
  • No previous pelvic radiation therapy (RT)
  • No previous prostatectomy
  • No previous invasive cancer (within 5 years before the prostate cancer diagnosis)except for skin non-melanoma cancer
  • Ability to understand character and individual consequences of the clinical trial
  • Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

  • No pathologically confirmed adenocarcinoma of the prostate
  • Pelvic lymph node metastasis (N1)
  • Distant metastasis (M1)
  • Urinary obstructive symptoms (IPSS > 20)
  • Previous pelvic radiotherapy
  • Previous prostatectomy
  • Severe systemic disorders
  • Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
  • Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer
  • Non conformity of the radiotherapy dose distribution when compared to the dose constraints
  • Psychiatric disorders or any other condition that can make unreliable the informed consent

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The Role of Stereotactic Body Radiotherapy in the Management of Castration-Resistant Prostate Cancer With Oligometastases: An Adaptive Phase II/III Randomized Trial.


Condition: Castration-resistant Prostate Cancer Patients With Oligometastases

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02685397

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Phase: Phase 2/Phase 3

Eligibility:

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

Inclusion Criteria:

  1. Age 18 or older and willing and able to provide informed consent;
  2. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
  3. Ongoing androgen deprivation therapy with a Gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy (i.e., surgical or medical castration);
  4. Patients who have not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the trial;
  5. Serum testosterone level ≤ 1.7 nmol/L (50 ng/dL) at the Screening visit;
  6. Patients receiving bisphosphonate therapy/Xgeva must have been on stable doses for at least 4 weeks;
  7. Progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy as defined in eligibility criterion #3:
  8. PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should be ≥ 2 μg/L (2 ng/mL);
  9. Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by CT/MRI. Patients whose disease spread is limited to regional pelvic lymph nodes, and previously radiated, are not eligible; i. Up to 5 metastatic sites ii. ≤ 4 tumours within any given organ system, excluding brain and liver (e.g. up to 4 bone metastases, or 4 lung metastases) iii. All sites of disease must be amenable to SBRT with no history of the metastases being irradiated; iv. In the case of a suspicious lesion in an unusual location such as lung or thoracic lymph nodes (without other abdominal lymph nodes), a biopsy should confirm prostate cancer origin.
  10. No prior cytotoxic chemotherapy for prostate cancer;
  11. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or Karnofsky performance status of > 70% or higher;
  12. Patients and their female partners of childbearing potential must be willing to use two forms of contraception (one of which must include a condom as a barrier method of contraception during sexual activity) throughout the duration of the study starting at screening and continuing for 3 months after the last dose of study drug or per local guidelines where these require additional description of birth control methods. These contraceptive methods must include the following:
  13. The use of condoms (barrier method) AND one of the following:
  14. the use of oral, injected or implanted hormonal methods of contraception by a female partner;
  15. placement of an intrauterine device (IUD) or intrauterine system (IUS) by a female partner;
  16. additional barrier method, such as occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/suppository by a female partner;
  17. tube ligation in the female partner;
  18. vasectomy or other procedure resulting in infertility (eg. bilateral orchiectomy) for ≥ 6 months. If the patient's partner is a pregnant woman, the patient must use a condom during sexual activity during and for 3 months after treatment with enzalutamide.
  19. Patients must agree to not donate sperm while taking study drug
  20. Estimated life expectancy of ≥ 6 months;
  21. Ability to swallow the study drug whole and comply with study.

Exclusion Criteria:

  1. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
  2. Known or suspected brain metastasis or active leptomeningeal disease;
  3. History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer;
  4. Absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, or hemoglobin < 5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic laboratory values obtained at the Screening visit);
  5. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal at the Screening visit;
  6. Creatinine > 177 μmol/L (2 mg/dL) at the Screening visit;
  7. Albumin < 30 g/L (3.0 g/dL) at the Screening visit;
  8. History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of enrollment (Day 1 visit);
  9. Clinically significant cardiovascular disease including:
  10. Myocardial infarction within 6 months;
  11. Uncontrolled angina within 3 months;
  12. Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is ≥ 45%;
  13. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
  14. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
  15. Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mmHg) at the Screening visit;
  16. Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG;
  17. Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening visit.
  18. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
  19. Major surgery within 4 weeks of enrollment (Day 1 Visit);
  20. Use of opiate analgesics (eg. morphine, fentanyl, etc.) for pain from prostate cancer within 4 weeks of enrollment (Day 1 visit). This does not apply to non-morphine drugs like codeine;
  21. Radiation therapy for treatment of the primary tumour within 3 weeks of enrollment (Day 1 visit);
  22. Radiation or radionuclide therapy for treatment of metastasis;
  23. Primary disease not treated
  24. More than 5 metastases
  25. Hormone naïve prostate cancer patients
  26. Treatment with flutamide within 4 weeks of enrollment (Day 1 visit);
  27. Treatment with bicalutamide or nilutamide within 6 weeks of enrollment (Day 1 visit);
  28. Treatment with 5-α reductase inhibitors (finasteride, dutasteride), estrogens, cytproterone within 4 weeks of enrollment (Day 1 visit)
  29. Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents and GnRH-analogue therapy) or other agents with anti-tumour activity within 4 weeks of enrollment (Day 1 visit);
  30. History of prostate cancer progression on ketoconazole;
  31. Prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., BMS 641988);
  32. Participation in a previous clinical trial of enzalutamide;
  33. Use of an investigational agent within 4 weeks of enrollment (Day 1 visit);
  34. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within four weeks of enrollment (Day 1 visit);
  35. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.

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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 N/A
  • 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)

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HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02918253

Sponsor: University Health Network, Toronto

Eligibility:

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

Inclusion Criteria:

  • Age ≥ 18 years
  • ECOG performance status 0
  • 2
  • Histological evidence of prostate adenocarcinoma
  • Low- and favorable intermediate-risk prostate cancer
  • Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
  • No contraindications to MRI:
  • Absent or unifocal intraprostatic disease (<2 separate/distinct lesions), on multiparametric MRI
  • Prostate gland size <80cc
  • Baseline IPSS <18
  • No TRUP within the past 6 months, nor large TURP defect
  • Absence of radiological evidence of regional or distant metastases (optional evaluation, at physician discretion)
  • No previous pelvic and/or prostate EBRT and/or brachytherapy
  • No contraindications to general anesthesia, or spinal/epidural anesthesia
  • Absence of bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily ceased during brachytherapy
  • No contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery
  • Negative past medical history of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE
  • Absence of latex allergy
  • No other medical conditions deemed by the PI to make patient ineligible for prostate HDR brachytherapy

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Phase II Study: [18F]DCFPyL PET/MRI for Personalizing Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy (MRgRT)


Condition: Post Prostatectomy

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03160794

Sponsor: University Health Network, Toronto

Eligibility:

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

Criteria: - ECOG performance status of 0-2 - Absence of significant comorbidities rendering patient nor suitable for curative ablative approaches - No history of non-skin malignancy - Histological evidence of prostate adenocarcinoma on previous radical prostatectomy. - No use of any form of hormonal therapy in the previous 12 months, or intention to start HT at time of enrollment. - Normal serum testosterone level ascertained within 4-6 weeks of enrollment - Absence of known metastatic disease - Radiological studies without evidence of regional or distant metastases: CT abdomen-pelvis and bone scan within previous 3 months - Able to lie supine at least 60 minutes to comply with imaging and treatment. - Absence of impaired renal function (calculated GFR > 30mL/min) - Absence of sickle cell disease or other hemoglobinopathies - No other medical conditions deemed by the PI to make patient ineligible for PET/MR scanning or SABR No contraindications to MRI: - Subject must weigh <136kg (scanner weight limit) - Subject must not have pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices not compatible with MRI - Prior anaphylactic reaction to gadolinium Rising PSA after maximal local therapies (radical prostatectomy and either adjuvant or salvage radiotherapy): - Three documented PSA rises, at least 1 month apart from post radiotherapy. - PSA value >0.1 and < 3 ng/mL, within 4-6 weeks of enrollment - No use of any forms of ADT in the previous 12 months nor contemplated to be used at time of study enrollment. Salvage ADT to be started when PSA reaches a value of 6.0ng/ml or greater.

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Phase 2 Trial Pembrolizumab or Pembrolizumab in Combination With Intratumoral SD-101 Therapy in Patients With Hormone-Naïve Oligometastatic Prostate Cancer Receiving Stereotactic Body Radiation Therapy and Intermittent Androgen Deprivation Therapy


Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03007732

Sponsor: Lawrence Fong

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Be willing and able to provide written informed consent/assent for the trial. 2. Be >=18 years of age on day of signing informed consent. 3. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. 4. Histologically documented adenocarcinoma of the prostate 5. Oligometastatic disease. In order to be eligible, the patient must have a total of <4 metastatic bone and/or metastatic lymph node sites based on bone and/or soft tissue lesions as defined by any of the following: 1. Bone metastases will be defined by bone imaging. If the patient has technetium bone scan, and/or sodium fluoride (NaF) PET performed, either study may be used for documenting metastases; both scans do not need to show the number of metastases required for study entry. For patients undergoing PSMA PET, only PSMA avid lesions that are consistent with metastasis will be counted as a site of metastasis. 2. Distant metastatic lymph node disease. A lymph node ≥1 cm in shortest dimension will be noted as involved with disease. Distant metastatic lymph nodes will be determined as any lymph nodes outside the confines of the true pelvis. For patients undergoing PSMA PET, only PSMA avid lesions that are consistent with metastasis will be counted as a site of metastasis. 3. Any other soft tissue lesion deemed by the physician to be consistent with distant metastatic disease. For patients undergoing PSMA PET, only PSMA avid lesions that have a CT or MRI correlate consistent with metastasis will be counted as a site of metastasis.
  • Note: Radiographic imaging performed as standard of care prior to obtaining informed consent and within 60 days of initiating study treatment may be used to assess oligometastatic disease during screening, rather than repeating scans. For patients who have started on ADT, they must have had imaging prior to initiation of hormonal therapy 6. Treatment naïve, defined as less than 2 months of standard of care ADT (e.g. GnRH agonist or antagonist with or without antiandrogen, including abiraterone) for metastatic hormone-sensitive prostate cancer prior to enrollment (at the time of consent) 7. No prior chemotherapy for prostate cancer 8. Not a candidate for or refuse chemotherapy 9. No prior prostatectomy or prostatic radiation 10. PSA >2 ng/mL at baseline or prior to initiation of hormonal therapy 11. Baseline testosterone >150 ng/dL if patient has not initiated hormonal therapy, for those patients who have already initiated hormonal therapy, baseline testosterone is not required 12. Consent to undergo mandatory prostatic core biopsies at the time of fiducial marker placement and 1-3 weeks after Cycle 1 Day 1 of pembrolizumab. 13. The effects of pembrolizumab on the developing human fetus is unknown. Men treated or enrolled on this protocol must agree to use adequate contraception prior to the first dose of study therapy, for the duration of the study participation, and for 120 days after the last dose of study therapy. Their partners should also be encouraged to use proper method of contraception. Their partners should also be encouraged to use proper method of contraception. 14. Demonstrate adequate organ function defined as: Adequate Organ Function Laboratory Values (Performed within 10 days of treatment initiation):
  • Absolute neutrophil count (ANC) ≥1,500 /microliter (mcL)
  • Platelets >=100,000 / mcL
  • Hemoglobin >=9 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
  • Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) <=1.5 X upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN. Creatinine clearance should be calculated per institutional standard
  • Serum total bilirubin <= 1.5 X ULN OR Direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN
  • Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
  • Albumin >2.5 mg/dL
  • International Normalized Ratio (INR) or Prothrombin Time (PT)
  • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Creatinine clearance should be calculated per institutional standard.

Exclusion Criteria:

  • 1. Patients who are not appropriate candidates for prostate or oligometastasis-directed SBRT 2. Patients with neuroendocrine or small cell features are not eligible. 3. Patients with evidence of liver metastasis are excluded. 4. Gonadotropin-releasing hormone (GnRH) agonists or GnRH antagonists (e.g., leuprorelin, degarelix) for > 2 months prior to consenting 5. Antiandrogens (e.g., bicalutamide, flutamide, nilutamide, abiraterone, enzalutamide) for > 2 months prior to consenting. Patients on 5-alpha reductase inhibitors are allowed on study. 6. Estrogen containing compounds for > 2 months prior to consenting 7. PC-SPES or PC-x products. Other herbal therapies or supplements will be considered by the Principle Investigator on a case-by-case basis based on their potential for hormonal or anti-cancer therapies. 8. Prior immunotherapy or chemotherapy for prostate cancer 9. Prior radiation therapy to the prostate 10. Prior prostatectomy 11. 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. 12. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of trial treatment, with the exception of steroids for adrenal insufficiency in which case prednisone =<10mg/day or its equivalent is allowed. 13. Has a known history of active Bacillus Tuberculosis (TB) 14. Hypersensitivity to pembrolizumab or any of its excipients. 15. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 16. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Note: Subjects with <= Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting 17. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include carcinoid, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 18. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroid treatment for at least 14 days prior to the first dose of study treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. 19. Has 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 (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 20. Has known history of, or any evidence of active, non-infectious pneumonitis. 21. Has an active infection requiring systemic therapy. 22. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 23. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 24. Expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 25. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 26. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 27. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (HCV) (i.e. HCV RNA [qualitative] is detected). 28. Has received a live vaccine within 30 days of planned start of study therapy. a. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed within 30 days.

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Development of Tissue Predictors of Abiraterone Benefit in Men With mCRPC


Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03176381

Sponsor: Tianjin Medical University Second Hospital

Phase:

Eligibility:

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

Inclusion Criteria:

  1. Participants who have given consent form;
  2. Patients with a confirmed diagnosis of mCRPC according to EAU 2017 guideline;
  3. Serum testosterone must reach castration level: <50 ng per deciliter;
  4. Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment.

Exclusion Criteria:

  1. Participants who are allergic to contrast medium;
  2. Patients were excluded if they planned to receive additional concurrent anticancer therapies;
  3. Patients doesn't sign an informed consent form.

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Neoadjuvant Degarelix +/- Apalutamide (ARN-509) Followed by Radical Prostatectomy for Intermediate and High-risk Prostate Cancer: a Randomized, Placebo-controlled Trial


Condition: Prostate Cancer, Neoadjuvant Therapy, Androgen Antagonists, Prostatectomy

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03080116

Sponsor: Universitaire Ziekenhuizen Leuven

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 2. Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations 3. Male aged 18 years or older (within 80 years) 4. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features 5. Diagnosis of intermediate (at least 2 of the following factors: cT2b, biopsy GS 7, PSA 10-20ng/ml) or high-risk prostatic adenocarcinoma (clinical stage≥T2c and/or biopsy GS≥8 and/or PSA>20ng/ml), cN0-cN1, cM0. 6. Patient amenable for open or robotic radical prostatectomy + pelvic lymph node dissection 7. ECOG performance status: 0-1 8. Adequate organ function as defined by the following criteria:
  • White blood cells (WBC) ≥ 4.0 x109/L
  • Platelet count ≥ 100 x109/L
  • Hemoglobin ≥9 g/dl
  • Creatinine ≤ 2 x ULN
  • Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x upper limit of normality (ULN)
  • Total serum bilirubin ≤1.5 x ULN.

Exclusion Criteria:

  • 1. Previous surgical/endoscopic treatments for prostatic disease 2. Herbal and non-herbal products that in the opinion of the investigator may decrease PSA levels 3. cM1 disease 4. Any contraindication for PET or MR investigations 5. History of seizure or condition that may pre-dispose to seizure (e.g., prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy) 6. Medications known to lower the seizure threshold 7. History of:
  • Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer currently in complete remission) within 5 years prior to randomization
  • Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
  • Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic BP ≥100 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
  • Gastrointestinal disorder affecting absorption 8. Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.

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