Clinical Trials for Prostate Cancer

Phase II Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic 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.

TrialFetch AI summary: Men with metastatic castration-resistant prostate cancer who progressed on at least 12 weeks of abiraterone plus prednisone receive abiraterone with dexamethasone, with or without metronidazole, to test whether switching steroids and suppressing androgen-producing gut anaerobes can restore abiraterone sensitivity. Metronidazole is investigational here for microbiome modulation; key exclusions include steroid contraindications, significant hepatic dysfunction, prolonged QTc, uncontrolled diabetes, active infection/IBD, and recent antibacterial therapy.

ClinicalTrials.gov ID: NCT06616597

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

No known activity

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

TrialFetch AI summary: Men with biochemical recurrence after prostatectomy, ECOG 0–2, candidates for salvage prostate bed/pelvic nodal RT and short-term ADT, are randomized by PET status: PET-negative receive standard salvage EBRT + 6 months ADT with or without 6 months apalutamide (androgen receptor inhibitor); PET-positive receive the same intensified systemic therapy with apalutamide with or without metastasis-directed RT to PET-avid extrapelvic sites. Primary endpoint is progression-free survival.

ClinicalTrials.gov ID: NCT04423211

A Phase Ib Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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.

TrialFetch AI summary: Men with mCRPC (ECOG 0–1) post–novel hormonal therapy and with PSMA-positive disease receive 177Lu-PSMA-617 combined with oral cabozantinib, a multi–tyrosine kinase inhibitor (targets MET/VEGFR2/AXL/RET) to assess safety and preliminary efficacy. Excludes prior PSMA RLT or cabozantinib and patients with significant cardiovascular, bleeding, CNS, or GI risk.

ClinicalTrials.gov ID: NCT05613894

A Phase II, Open-label, Multi-Center, Randomized Study Comparing the Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC)

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.

TrialFetch AI summary: PSMA PET–positive mCRPC patients with ECOG 0–2 who progressed after exactly one prior second-generation ARPI given before the mCRPC setting; excludes prior PSMA RLT or taxane in CRPC and those appropriate for PARP inhibitors due to HRR mutations. Randomizes to lutetium-177 vipivotide tetraxetan (PSMA-targeted beta-emitting radioligand therapy) plus an ARPI (enzalutamide or abiraterone) versus lutetium-177 vipivotide tetraxetan alone as first-line mCRPC treatment.

ClinicalTrials.gov ID: NCT06894511

A Phase I/II Study of M9241 With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and M9241 With Docetaxel in Castration Resistant Prostate Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 prostate cancer: mCSPC within ~4 months of starting ADT (high-volume for expansion) receive ADT + docetaxel + abiraterone/prednisone, with addition of M9241 (NHS‑IL12), a tumor-targeted IL‑12 immunocytokine that binds exposed histones to deliver IL‑12 to the tumor microenvironment. mCRPC patients previously treated with a modern ARSI (but not progressed on prior mCSPC docetaxel) receive docetaxel/prednisone plus M9241 from cycle 2 onward.

ClinicalTrials.gov ID: NCT04633252

Phase II Study of Talazoparib With Androgen Deprivation Therapy and Abiraterone in Castration Sensitive Prostate Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

No known activity

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

TrialFetch AI summary: Metastatic castration-sensitive prostate cancer in men receiving standard ADT plus abiraterone/prednisone, adding talazoparib (a PARP inhibitor targeting DNA damage repair) to enhance disease control irrespective of homologous recombination repair status. Excludes prior chemo for metastatic disease; allows recent initiation of LHRH therapy and prior adjuvant ADT with testosterone recovery.

ClinicalTrials.gov ID: NCT04734730

Metastasis-directed Radiotherapy (MDRT) for Men With De-novo Oligometastatic Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)

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.

TrialFetch AI summary: Men with newly diagnosed de-novo oligometastatic prostate adenocarcinoma (ECOG 0–1) receiving 12 months of standard systemic therapy (ADT ± ARSI) plus definitive prostate-directed therapy are randomized to add metastasis-directed radiotherapy (stereotactic/hypofractionated RT to all metastatic sites by week 24) versus standard care alone. Excludes castration-resistant disease, visceral/intracranial metastases, prior definitive local/systemic therapy, and significant comorbidities.

ClinicalTrials.gov ID: NCT06150417

Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)

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.

TrialFetch AI summary: Adults with metastatic prostate, urothelial, or renal cell carcinoma on a systemic regimen with overall benefit but ≤5 oligo-progressive lesions receive local ablation (SABR or IR ablation) to progressing sites while continuing the same systemic therapy. Aims to prolong disease control without changing systemic treatment; excludes intracranial progression or contraindications to ablation.

ClinicalTrials.gov ID: NCT06101290

A Phase 1 Open-label, Dose-finding Multi-center Trial of [177Lu]Ludotadipep in Metastatic Castration-resistant Prostate Cancer Patients, Followed by an Open-label, Repeat Dose, Multi-center Phase 2a Trial to Assess Safety and Efficacy

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 PSMA-positive metastatic castration-resistant prostate cancer after at least one AR pathway inhibitor (taxane-exposed, ineligible, or declining allowed) receive [177Lu]Ludotadipep, a lutetium-177 beta-emitting PSMA-targeted radioligand with albumin-binding to enhance tumor uptake, given as a single dose for dose-finding followed by repeat dosing every ~8 weeks. Excludes prior PSMA radioligand therapy and requires adequate organ function and ECOG 0–2 (Phase 1) or 0–1 (Phase 2a).

ClinicalTrials.gov ID: NCT05458544

An Open-Label, Phase 1/1b Study of ORIC-944 as a Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 prostate cancer on castrate testosterone, including mCRPC after prior ARPI (and limited prior chemo), receive the investigational oral EED-directed PRC2 inhibitor ORIC-944 as monotherapy or combined with an ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide). The trial seeks safety/PK and early activity, with dose-escalation/optimization cohorts stratified by prior ARPI exposure.

ClinicalTrials.gov ID: NCT05413421