Clinical Trials for Prostate Cancer

High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Enrolling men with metastatic castration-resistant prostate cancer who have inactivating mutations in ATM, CDK12, or CHEK2 after prior next-generation AR-signaling inhibitor, asymptomatic/minimally symptomatic, ECOG 0–1. Patients receive bipolar androgen therapy (intermittent high-dose testosterone while maintaining castration) to exploit DNA damage/replication stress and AR signaling disruption, hypothesized to be particularly active in DDR-deficient tumors.

ClinicalTrials.gov ID: NCT05011383

A Phase I/II Study to Determine the Safety and Efficacy of a Combination of Green Tea and Quercetin With Docetaxel in Castration-resistant Prostate Cancer Patients

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Men with metastatic castration-resistant prostate cancer progressing on continuous ADT and prior AR pathway inhibitors, eligible to start docetaxel/prednisone, are randomized to docetaxel/prednisone plus green tea extract and quercetin versus placebo. The investigational add-on comprises dietary polyphenols (EGCG-rich green tea extract and quercetin) with proposed chemosensitizing/anti-tumor activity via signaling, oxidative stress, and drug transport/metabolism modulation; the study evaluates PSA response, radiographic outcomes, safety, and pharmacokinetics.

ClinicalTrials.gov ID: NCT06615752

A Phase II Trial of FASN Inhibition by Omeprazole in Combination With Cabazitaxel in Patients With Docetaxel- and Castration-Resistant Prostate Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Metastatic castration-resistant prostate cancer progressing on prior taxane therapy (docetaxel or cabazitaxel); ECOG 0–2. Adds high-dose omeprazole (repurposed fatty acid synthase inhibitor) to ongoing cabazitaxel or docetaxel to assess radiographic response, PSA/pain outcomes, and pharmacodynamic target engagement.

ClinicalTrials.gov ID: NCT04337580

Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Veterans with oligometastatic or oligo-recurrent prostate cancer (1–10 PSMA/fluciclovine/choline PET-detected lesions; ECOG ≤2) are randomized to standard systemic therapy (ADT ± first-generation antiandrogen; optional intensification with docetaxel, abiraterone, apalutamide, or enzalutamide; de novo cases also get prostate RT) with or without PET-directed local therapy to all sites (SBRT/surgery and salvage local therapy when feasible). No investigational drugs; compares addition of metastasis-directed therapy to contemporary systemic care.

ClinicalTrials.gov ID: NCT04787744

A Phase 2 Study of Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Metastatic Castration Resistant Prostate Cancer

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Men with mCRPC after ≥1 second-generation ARSI (± up to two taxane lines), PSMA-PET–avid disease, and ECOG 0–1 receive pembrolizumab (PD‑1 inhibitor) plus 177Lu‑PSMA‑617 radioligand therapy, with two initial Lu‑PSMA doses then adaptive re-dosing at PSA rise until progression/toxicity. Excludes prior PSMA-directed therapy or checkpoint inhibitors; allows treated/stable brain metastases.

ClinicalTrials.gov ID: NCT05766371

Phase 1/2 Dose-Escalation and Cohort Study of STEAP1 CART With Enzalutamide in Participants With mCRPC

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with metastatic castration-resistant prostate adenocarcinoma after ≥2 prior lines (including a next-generation AR inhibitor) and castrate testosterone receive lymphodepleting cyclophosphamide/fludarabine followed by a single infusion of autologous STEAP1-directed CAR T cells plus continuous enzalutamide. The investigational product is a CAR T therapy targeting STEAP1 to direct T‑cell cytotoxicity against STEAP1-expressing tumors; key exclusions include active autoimmune disease requiring immunosuppression, uncontrolled infection, and untreated/symptomatic brain metastases.

ClinicalTrials.gov ID: NCT06236139

A Multicenter, Open-label Phase 1/2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced/metastatic solid tumors refractory to standard therapy (mCRPC, metastatic breast cancer subtypes including TNBC, HR+/HER2− or HER2-low, HR−/HER2+, NSCLC, CRC, PDAC) receive MBRC-201, an investigational antibody‑drug conjugate targeting a tumor-associated antigen and delivering a likely topoisomerase I inhibitor payload. Requires ECOG 0–2 and measurable disease in expansion/Phase 2; excludes active CNS disease and prior camptothecin‑payload ADCs in later phases.

ClinicalTrials.gov ID: NCT07145255

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial involves patients with advanced or metastatic solid tumors expressing Nectin-4, including urothelial carcinoma, triple-negative breast cancer, non-small cell lung cancer, and ovarian cancer, who have exhausted standard therapy options. It evaluates LY4052031, an antibody-drug conjugate that targets Nectin-4 to deliver a topoisomerase I inhibitor, aiming to assess its safety, tolerability, and efficacy in these patients.

ClinicalTrials.gov ID: NCT06465069

Phase I/II First-in-Human Study of TT-10 (PORT-6), an Adenosine 2A Receptor Antagonist, and PORT-7, an Adenosine 2B Receptor Antagonist, as Single Agents and in Combination in Participants With Advanced Selected Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial enrolls patients aged 18 and older with advanced solid tumors, including RCC, CRPC, NSCLC, SCCHN, CRC, endometrial, and ovarian cancers, who have failed or are ineligible for standard treatments, to evaluate TT-10, an adenosine A2A receptor antagonist, and TT-4, an adenosine A2B receptor antagonist, administered as single agents and in combination.

ClinicalTrials.gov ID: NCT04969315

A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Eligible patients are adults with advanced or metastatic solid tumors—including urothelial, triple negative breast, non-small cell lung, esophageal, pancreatic, ovarian, cervical (squamous), head and neck squamous cell, and prostate cancers—who have exhausted standard therapies and have ECOG 0–1. All participants receive intravenous LY4101174, a novel antibody-drug conjugate targeting nectin-4 and delivering a topoisomerase I inhibitor (exatecan).

ClinicalTrials.gov ID: NCT06238479