Prostate Cancer

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A Phase I Study to Evaluate PSCA-Targeting Chimeric Antigen Receptor (CAR)-T Cells for Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer


Condition: Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03873805

Sponsor: City of Hope Medical Center

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • All participants must have the ability to understand and the willingness to sign a written informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0
  • 2.
  • Documented castration resistant prostate cancer (mCRPC) (Note: castration will be defined by a testosterone < 50 ng/dL achieved by orchiectomy or luteinizing hormone-releasing hormone [LHRH] agonist/antagonist therapy)
  • Documented PSCA+ tumor expression as evaluated by City of Hope (COH) Pathology Care
  • Progression of disease manifest by one of the following means during treatment with at least one advanced androgen targeted therapy (e.g., abiraterone or enzalutamide)
  • Rising PSA documented on 2 occasions at least 7 days apart, with absolute increase > 2 ng/dL despite testosterone < 50 OR
  • Radiographic evidence of new metastatic foci on computed tomography (CT) or bone scan, or soft tissue progression by Response Evaluation Criteria in Solid Tumors (RECIST)
  • Prior chemotherapy with cabazitaxel and/or docetaxel is allowed but not required. If there has been prior chemotherapy, at least 2 weeks must have elapsed prior to leukapheresis
  • Prior radiotherapy is allowed provided it was not administered to the only evaluable site of disease and was > 14 days prior to leukapheresis
  • No known contraindications to leukapheresis, steroids or tocilizumab
  • Total serum bilirubin =< 2.0 mg/dL (to be performed within 42 days of signing the main study consent)
  • Patients with Gilbert syndrome may be included if their total bilirubin is =< 3.0 x upper limit of normal (ULN) and direct bilirubin =< 1.5 x ULN
  • Aspartate aminotransferase (AST) < 3 x ULN (to be performed within 42 days of signing the main study consent)
  • Alanine aminotransferase (ALT) < 3 x ULN (to be performed within 42 days of signing the main study consent)
  • Creatinine clearance of >= 50 mL/min per the Cockcroft-Gault formula (to be performed within 42 days of signing the main study consent)
  • Cardiac function (12 lead-electrocardiography [ECG]) (to be performed within 42 days of signing the main study consent)
  • Left ventricular ejection fraction > 40% (to be performed within 42 days of signing the main study consent)
  • Participants of reproductive potential must agree to use acceptable birth control methods throughout study therapy and for 3 months after final dose of study treatment

Exclusion Criteria:

  • Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of signing the main consent
  • Participants with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition or other agents used in this study
  • Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
  • History of stroke or intracranial hemorrhage within 6 months prior to signing the main consent
  • History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for >= 3 years
  • Uncontrolled active infection
  • Active hepatitis B or hepatitis C infection
  • Human immunodeficiency virus (HIV) infection
  • Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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A Study to Evaluate the Safety and Efficacy of IMMU-132 (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
  • Received enzalutamide, abiraterone, or apalutamide. Subjects who have received combination enzalutamide/abiraterone or combination ARN-509/abiraterone as part of ongoing clinical trials are allowed. Subjects who have received TAK-700 (Orteronel®), TOK-001 (Galeterone®), or 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, 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 (Appendix A)
  • 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
  • Discontinued enzalutamide, apalutamide, or abiraterone ≥4 weeks prior to study drug initiation
  • 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 for CRPC. Prior docetaxel for castration-sensitive disease is permitted.
  • Received more than one second generation, FDA approved, AR-directed line of therapy: i.e., sequential enzalutamide-abiraterone or abiraterone-enzalutamide will not be 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 Randomized, Phase II Study of Apalutamide +/- Stereotactic Body Radiotherapy (SBRT) in Castration-Resistant Prostate Cancer Patients With Oligometastatic Disease on PSMA-PET Imaging


Condition: Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, PSA Progression, Stage IV Prostate Adenocarcinoma AJCC v7

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03503344

Sponsor: University of California, San Francisco

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Progressive, castration-resistant prostate cancer demonstrated during continuous antiandrogen therapy (ADT), defined as 3 PSA rises at least 1 week apart, with a minimum PSA > .05 ng/mL obtained during screening.
  • At least one but no more than 5 discrete PSMA-avid radiation fields on baseline PSMA-PET scan; all PSMA-avid lesions in radiation fields must be amenable to SBRT in judgment of treating radiation oncologist; there are no restrictions on site of lesion/radiation fields (e.g. bone, lymph node, prostate, visceral). Equivocal lesions/radiation fields on PSMA PET scan that are not definitive for metastasis will not count towards the limit of 5 radiation fields and will not undergo SBRT
  • Surgically or medically castrated, with testosterone levels of < 50 ng/dL during screening; if the patient is medically castrated, continuous dosing with luteinizing hormone-releasing hormone (LHRH) analogue must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study to maintain castrate levels of testosterone including post-treatment follow up period
  • No prior systemic treatment initiated for the treatment of castration resistant prostate cancer, including abiraterone acetate, enzalutamide, apalutamide, darolutamide, other novel AR or CYP17 antagonist, or docetaxel.
  • Patients receiving bone loss prevention treatment with bone-modifying agents (e.g. denosumab, zoledronic acid) must be on stable doses for at least 4 weeks prior to randomization
  • Patients who received a first generation anti-androgen (e.g., bicalutamide, flutamide, nilutamide) as most recent treatment must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after washout
  • At least 4 weeks or 5 half-lives, whichever is shorter, must have elapsed from the use of any anti-cancer therapy, other than Luteinizing hormone-releasing hormone (LHRH) analog or first generation antiandrogen, prior to randomization
  • At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization
  • Age > 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1
  • Resolution of all acute toxic effects of prior therapy or surgical procedure to grade 1 or baseline prior to randomization
  • 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 normal (ULN)
  • Total serum bilirubin ≤ 1.5 x ULN; in subjects with known or suspected Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, direct bilirubin is ≤ 1.5 x ULN
  • Glomerular filtration rate ≥ 45 ml/min based on Cockcroft-Gault equation
  • Absolute neutrophil count (ANC) ≥ 1500/microliter
  • Platelets ≥ 75,000/microliter without transfusion and/or growth factors in the 3 months prior to randomization
  • Hemoglobin ≥ 9.0 g/dL without transfusion and/or growth factors in the 3 months prior to randomization
  • Serum albumin ≥ 3.0 g/dL
  • Signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial prior to randomization
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures, including ability to swallow study drug tablets and long-term follow-up
  • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug

Exclusion Criteria:

  • Presence of visceral lesions (e.g. lung, liver) detectable on baseline imaging or bone lesions requiring focal radiation treatment at the time of study entry
  • 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 central nervous system (CNS) or meningeal disease which may require treatment with surgery or radiation therapy
  • Concurrent therapy with any of the following (all must have been discontinued or substituted for at least 1 week prior to randomization, except for medications known to lower seizure threshold which must be discontinued or substituted at least 4 weeks prior to randomization)
  • Medications known to lower the seizure threshold
  • Herbal (e.g., saw palmetto) and non-herbal (e.g., pomegranate) products that may decrease PSA levels
  • Systemic (oral/intravenous (IV)/intramuscular (IM)) corticosteroids; patients on chronic stable dose of steroids at an equivalent dose of prednisone ≤ 10 mg daily may be permitted to enroll at the discretion of principal investigator
  • Any other experimental treatment on another clinical trial
  • Any of the following within 6 months 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
  • Uncontrolled hypertension at study entry; patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by antihypertensive treatment
  • Gastrointestinal disorder affecting absorption
  • Secondary malignancy requiring active treatment except for non-melanoma skin cancer and superficial bladder cancer
  • Any medical condition that would be a contra-indication to radiation therapy, such as inflammatory bowel disease
  • Spinal cord compression or impending spinal cord compression
  • 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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Phase 2, Multicenter, Prospective Cohort Study, Estimating the Efficacy of Focused HIFU Therapy in Patients With Localized Intermediate Risk Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03568188

Sponsor: Hospices Civils de Lyon

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

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

Exclusion Criteria:

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

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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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F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer, Comparison With 18F-Fluciclovine


Condition: Prostate Cancer Recurrent

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04239742

Sponsor: Radboud University

Eligibility:

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

Inclusion Criteria:

  • Males ≥ 18 years
  • Histologically proven adenocarcinoma of the prostate
  • Prior local treatment with curative intent
  • Biochemical recurrence with (rising) PSA-levels of 0.2-5.0 ug/L
  • Referred by urologist for PET/CT for localization of the recurrence
  • PSA level determined <8 weeks before study participation
  • Willing to sign informed consent

Exclusion Criteria:

  • Contra-indications for PET-CT: claustrophobia or inability to lay still for the duration of the exam.
  • Other cancer <2 years prior to biochemical recurrence of prostate cancer

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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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The Impact of Continuous Versus Intermittent Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients: A Multicenter, Randomized Clinical Trial


Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04248621

Sponsor: Wonju Severance Christian Hospital

Phase: Phase 4

Eligibility:

  • Age: minimum 50 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Men aged over 50 yrs old with histologically diagnosed prostate cancer (localized, locally advanced, metastatic prostate cancer) who are treated with primary ADT for newly diagnosed prostate cancer or salvage ADT at biochemical recurrence following radical prostatectomy. .

Exclusion Criteria:

  1. men with double primary malignancies,
  2. men who have been treated with ADT or other drug therapy such as denosumab, bisphosphonate or steroid,
  3. men with osteoporosis at baseline (T-score ≤ -2.5),
  4. men with a known bone disease,
  5. men with poor performance status (i.e. Eastern Cooperative Oncology Group performance status 4),
  6. men with life expectancy < 12 months,
  7. men with increased serum PSA levels (≥ 4 ng/dL) or testosterone levels (≥ 50 ng/dL) even after 6 month ADT,
  8. men who are not able to understand trial information or informed consent,

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The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer


Condition: Prostate Cancer, Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04179968

Sponsor: Dana Mathews

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician
  • Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4
  • In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.
  • Patients must be scheduled for biopsy or radical prostatectomy
  • Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study
  • Patients must be medically stable as judged by the patient's physician
  • Patients must be able to lie still for a total of 60 minutes for the PET/CT scans
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study
  • Patients who have had a prior biopsy for prostate cancer cannot participate in the study
  • Patients who have been treated for cancers other than skin cancers
  • Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
  • Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (>200 kilograms or 440 pounds)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI
  • Prior TURP/BPH procedures, including steam/laser therapies

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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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A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04147806

Sponsor: Albert Einstein College of Medicine

Phase: Phase 2

Eligibility:

  • Age: minimum 50 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Signed study specific informed consent form;
  • Histologic confirmation of adenocarcinoma of the prostate by biopsy;
  • PSA ≤ 20 ng/mL;
  • Gleason score 7;
  • Staging MRI must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c;
  • No direct evidence of regional or distant metastases after appropriate staging studies;
  • Age ≥ 50;
  • Performance Status 0-2;
  • Internation Prostate Symptom Score score must be ≤ 15 (alpha blockers allowed);
  • CT scan 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 5 years
  • Tumour Clinical stage T3 or T4 on MRI
  • PSA > 20 ng/mL
  • Gleason score > 7
  • Previous pelvic radiotherapy
  • Previous surgery for prostate cancer
  • Previous transurethral resection of the prostate (TURP)
  • History of Crohn's Disease or Ulcerative Colitis
  • 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, or enzalutamide) 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
  • Platelets > 100,000 / mm3
  • Creatinine < 1.5 x institutional upper limit of normal (ULN)
  • Total bilirubin < 1.5 x institutional ULN OR direct bilirubin < ULN for participants with total bilirubin levels > 1.5 x ULN
  • Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT) < 2.5 x institutional upper limit of normal
  • Prothrombin Time (PT) or International Normalized Ratio (INR) < 1.5 x ULN unless participant is receiving anticoagulant therapy and PT is within therapeutic range of intended use of anticoagulant (only required for participants receiving biopsy)
  • Partial Thromboplastin Time (PTT) < 1.5 x ULN unless participant is receiving anticoagulant therapy and a PTT is within therapeutic range of intended use of anticoagulant (only required for participants receiving biopsy)
  • 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
  • 5. 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 3 months 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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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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A Phase I/IIa Study Evaluating the Safety and Tolerability of Intratumoral Administration of ORCA-010 in Treatment-Naïve Patients With Localized Prostate Cancer.


Condition: Adenocarcinoma of the Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04097002

Sponsor: Orca Therapeutics B.V.

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: Male

Inclusion Criteria:

  • 1. Histologically confirmed adenocarcinoma of the prostate, which is localized to the prostate ( within 24 months of screening) 2. Absence of lymph node, bone or other metastases as determined by MRI and CT scan, Bone Scan or nano-MRI (≤3 months prior to first administration) 3. Men between 18 and 75 years inclusive 4. ECOG status 0 or 1 5. Ability to understand and willingness to sign informed consent 6. Adequate liver, renal and bone marrow function: AST & ALT < 2.5 x ULN, total bilirubin < 1.5 x ULN, Alkaline phosphatase < 3 x ULN, Serum creatinine < 1.5 x ULN, Haemoglobin > 9.0 g/dL (5.59 mmol/L), Platelet count > 100x10*9/L, Neutrophils > 1.5x10*9/L, INR < 1.5xULN 7. eGFR ≥ 30 mL/min, using the Cockcroft
  • Gault Equation: Creatinine Clearance = [{(140
  • age in years) x (weight in kg)} x 1.23] /serum Creatinine in Mmol/L

Exclusion Criteria:

  1. Tumor not accessible for injection
  2. Prior treatment of prostate cancer with radiation therapy or brachytherapy
  3. Prior use of chemotherapy/hormone therapy for treatment of cancer
  4. Target tumor adherent to a major vascular structure
  5. Participation in any investigational drug study within the last 12 months prior to first administration of ORCA-010
  6. Clinically significant active infection (viral or bacterial)
  7. Known immunosuppressive diseases (e.g. HIV, Hepatitis B and C)
  8. History of any other oncological malignancy, excluding basal cell carcinoma of the skin, in the past 5 years
  9. Not willing to refrain from sexual activities or use a double barrier contraceptive device (condom with foam or vaginal suppository, diaphragm with spermicide) after administration of ORCA-010 and until 42 days after the last ORCA-010 administration
  10. Severe obesity defined as Body Mass Index (BMI) > 30 kg/m2
  11. Positive for adenovirus in throat swap or serum as determined by PCR at screening
  12. Recent (within 3 months prior to enrolment in the study) history of alcohol abuse or other substances such as barbiturates, cannabinoids and amphetamines or a positive urine screen for drugs of abuse
  13. Use of medication known to have immunosuppressive effects, except topical/inhaled steroids under 10 mg/day prednisolone equivalent (See Appendix 7)
  14. Use of systemic antiviral medication within 3 months prior to enrolment in the study
  15. Use of any anti-coagulants/blood thinner except for ASA 81mg
  16. Any condition that in the opinion of the Investigator could interfere with the conduct of the study
  17. For Part B only: Subjects enrolled in Part A of the study

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