Clinical Trials for Prostate Cancer

A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

Active drug

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

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: This trial enrolls adults with advanced or metastatic solid tumors (excluding primary CNS tumors); for IDE161 monotherapy, patients must have BRCA1/2 or other homologous recombination deficiency gene alterations, while the combination arm is for patients with advanced or recurrent endometrial cancer who have progressed on prior anti–PD-1/L1 therapy. IDE161 is an investigational oral inhibitor of poly(ADP-ribose) glycohydrolase (PARG), targeting DNA repair in HR-deficient tumors, given alone or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors

Active drug

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

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: This trial enrolls adults with locally advanced or metastatic solid tumors—especially those with Wnt pathway activating mutations such as APC or CTNNB1—including select colorectal, liver, desmoid, and prostate cancers, testing the oral β-catenin:TCF4 inhibitor FOG-001 as monotherapy or in combination with standard regimens (e.g., mFOLFOX-6 plus bevacizumab, nivolumab, or trifluridine/tipiracil plus bevacizumab). Eligible patients must have ECOG 0-1 and no significant bone, CNS, cardiac disease, or active IBD.

ClinicalTrials.gov ID: NCT05919264

(ID-COMET) A Randomized Phase III Trial of Immediate Versus Six-Month Delayed Comprehensive Treatment of 1-10 Oligometastatic Tumors With or Without Synchronous Primary

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 and children (ECOG 0–3) with newly diagnosed oligometastatic lung, colorectal, or prostate cancer (1–10 lesions; brain mets excluded) are randomized to immediate stereotactic ablative radiotherapy (SABR) to all treatable sites plus standard systemic therapy versus initial standard therapy with SABR delayed ~6 months; a separate cohort allows immediate SABR for broader oligometastatic/oligoprogressive disease. Compares survival/ADT-free survival and safety/quality of life while standard systemic regimens are given per tumor type.

ClinicalTrials.gov ID: NCT06563388

A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

Active drug

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

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 adults with advanced solid tumors or lymphomas, including molecularly defined cohorts such as ARID1A-mutant endometrial/ovarian clear cell and other solid tumors, BAP1-loss mesothelioma, PTCL/DLBCL (including EZH2-mutant), and mCRPC. Investigational therapy is tulmimetostat (CPI-0209), an oral dual EZH2/EZH1 inhibitor, given as monotherapy across cohorts and combined with enzalutamide in mCRPC.

ClinicalTrials.gov ID: NCT04104776

Carboplatin and Cabazitaxel Versus 177Lu-PSMA-617 in Patients With Aggressive, Metastatic Castrate-resistant Prostate Cancer (CATCH-177)

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 aggressive, PSMA-PET–positive mCRPC after at least one AR pathway inhibitor (often post-docetaxel) are randomized to cabazitaxel plus carboplatin versus 177Lu-PSMA-617 radioligand therapy (binds PSMA to deliver beta-emitting lutetium-177). Eligible patients have high-risk features (e.g., visceral disease, ≥5 bone mets, lower PSMA SUVmean, or TP53/PTEN/RB1 alterations) and ECOG 0–2.

ClinicalTrials.gov ID: NCT06738303

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic 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.

No known activity

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

TrialFetch AI summary: Men with de novo metastatic prostate adenocarcinoma who complete 22–28 weeks of guideline-concordant ADT-based systemic therapy without progression (castrate T, PS 0–1) are randomized to continue systemic therapy alone versus adding definitive treatment of the primary (radical prostatectomy or definitive prostate radiation). Systemic therapy may include surgical or medical castration (LHRH agonists/antagonist), first-generation antiandrogens, and/or abiraterone; docetaxel allowed only during induction.

ClinicalTrials.gov ID: NCT03678025

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Active drug

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

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: Adults with metastatic castration-resistant prostate cancer on continuous androgen suppression, including post–novel hormonal therapy and often post-taxane, receive xaluritamig (AMG 509), a STEAP1×CD3 bispecific T‑cell engager, as IV or SC monotherapy or in combination with abiraterone or enzalutamide. Excludes small cell/neuroendocrine histology and untreated CNS disease; aims to define dosing while assessing early antitumor activity.

ClinicalTrials.gov ID: NCT04221542

A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to 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: Open-label rollover for men with prostate cancer who are deriving benefit from ongoing enzalutamide-based therapy in a prior Astellas/Medivation trial, continuing the same regimen without change. Participants may remain on enzalutamide monotherapy or continue prior combinations (enzalutamide plus abiraterone/prednisone or plus leuprolide); enzalutamide is an androgen receptor signaling inhibitor.

ClinicalTrials.gov ID: NCT02960022

Phase II Trial of Targeted Radiation With no Castration for 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: Adults with PSMA-avid oligometastatic castration-resistant prostate cancer (≤10 lesions) who have received at least one ARSI stop ongoing ADT and receive comprehensive lesion-directed SBRT plus 177Lu‑PSMA‑617 radioligand therapy; they are then randomized to observation versus physiologic testosterone replacement. Excludes visceral (liver/brain) metastases and neuroendocrine histology.

ClinicalTrials.gov ID: NCT06084338

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