Clinical Trials for Prostate Cancer

A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

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.

Active drug

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

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.

HealthScout AI summary: Adults with metastatic castration-resistant prostate adenocarcinoma, asymptomatic/mildly symptomatic, after exactly one prior ARPI (no small cell/neuroendocrine features; excluding brain or liver metastases), are randomized to BMS-986365 (gridegalutamide), an oral cereblon-recruiting androgen receptor degrader/antagonist, versus investigator’s choice of docetaxel/prednisone or a second ARPI (abiraterone/prednisone or enzalutamide). Primary endpoint is radiographic PFS with blinded central review.

ClinicalTrials.gov ID: NCT06764485

A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)

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.

Active drug

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

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.

HealthScout AI summary: Adults with metastatic castration-resistant prostate cancer progressing after ADT and 1–2 prior AR pathway inhibitors (no prior taxane for mCRPC) are randomized to ifinatamab deruxtecan (I-DXd), a B7-H3–targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, versus docetaxel plus prednisone. Key exclusions include prior steroid-requiring ILD/pneumonitis and significant cardiovascular disease; primary endpoints are OS and rPFS.

ClinicalTrials.gov ID: NCT06925737

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

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.

Active drug

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

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.

HealthScout AI summary: Adults with mCRPC who have progressed on at least one AR-directed therapy and received exactly one prior taxane in the mCRPC setting (ECOG 0–1) are randomized to xaluritamig, a STEAP1×CD3 bispecific T‑cell engager, versus investigator’s choice of cabazitaxel or a second AR-directed therapy (abiraterone or enzalutamide). Suitable for patients with measurable or bone disease and no prior STEAP1‑targeted therapy; primary endpoint is overall survival.

ClinicalTrials.gov ID: NCT06691984

A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)

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.

Active drug

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

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.

HealthScout AI summary: Men with metastatic castration-resistant prostate cancer who progressed on abiraterone (no prior ARSI, limited prior chemo) are randomized to mervometostat (PF-06821497), an EZH2 inhibitor, plus enzalutamide versus physician’s choice of enzalutamide or docetaxel. Intended for ECOG 0–2, castration-resistant patients without small cell features or active CNS disease.

ClinicalTrials.gov ID: NCT06551324

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

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.

Active drug

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

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.

HealthScout AI summary: Adults with progressive mCRPC after ≥1 ARSI (and usually prior taxane) are assigned to treatment by tumor genomics: valemetostat (dual EZH1/EZH2 inhibitor) for select epigenetic targets, carboplatin plus cabazitaxel for aggressive/neuroendocrine features, or physician-choice therapy (cabazitaxel, abiraterone/prednisone, enzalutamide, or Lu-177-PSMA for PSMA-positive disease). Includes variant histologies, allows re-registration at progression, and requires adequate organ function with standard imaging per PCWG3/RECIST.

ClinicalTrials.gov ID: NCT06632977

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)

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.

Active drug

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

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.

HealthScout AI summary: Men with metastatic castration-resistant prostate adenocarcinoma (ECOG 0–1) who are ARSI- and abiraterone-naïve (prior docetaxel for mCSPC allowed if no early progression) are randomized to enzalutamide plus the EZH2 inhibitor mevrometostat (PF-06821497) vs enzalutamide alone. The investigational agent targets EZH2/PRC2 to reduce H3K27 methylation and potentially enhance antitumor activity; primary endpoint is rPFS.

ClinicalTrials.gov ID: NCT06629779

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

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.

Active drug

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

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.

HealthScout AI summary: Men with metastatic castration-sensitive prostate adenocarcinoma (ECOG 0–1) are randomized to physician’s choice of abiraterone, enzalutamide, or darolutamide plus the PARP1-selective inhibitor saruparib (AZD5305) versus placebo, with parallel cohorts for HRR-mutated and non-HRR–mutated disease. Saruparib selectively inhibits and traps PARP1 to exploit HRR deficiency, aiming to improve radiographic PFS while potentially reducing hematologic toxicity seen with nonselective PARP inhibitors.

ClinicalTrials.gov ID: NCT06120491

PSMAcTION: A Phase II/III, Open-label, International, Multicenter, Randomized Study of AAA817 Versus Standard of Care in the Treatment of Adult Participants With PSMA Positive Metastatic Castration-resistant Prostate Cancer Who Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

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.

Active drug

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

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.

HealthScout AI summary: Adults with PSMA-positive mCRPC who have progressed after ARPI, taxane chemotherapy, and [177Lu]Lu‑PSMA are randomized to the alpha-emitting PSMA radioligand AAA817 (225Ac‑PSMA‑617) versus investigator’s choice of standard of care. AAA817 targets PSMA to deliver actinium‑225 alpha radiation to tumor cells; xerostomia is a known risk, with monitoring for hematologic and renal toxicity.

ClinicalTrials.gov ID: NCT06780670

A Phase 2/3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of FPI-2265 (225Ac-PSMA-I&T) in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC), Previously Treated With 177Lu-PSMA Radioligand Therapy (RLT)

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.

Active drug

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

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.

HealthScout AI summary: PSMA PET–positive mCRPC patients with prior 177Lu-PSMA radioligand therapy (completed >6 weeks) and ECOG 0–1 receive FPI-2265, an actinium-225 PSMA-I&T alpha-emitting radioligand that delivers high-LET DNA damage to PSMA-expressing tumors, with dose/schedule optimization across arms. Key exclusions include >2 prior CRPC cytotoxic regimens, liver metastases (Phase 2), early progression on prior 177Lu-PSMA, CNS mets unless stable, and significant unresolved toxicities.

ClinicalTrials.gov ID: NCT06402331

Phase II Single Arm Study Testing SBRT, Adenosine Signaling Modulation (AB680, AB928), and Immune Checkpoint Inhibition (AB122) for Men With Hormone Sensitive Oligometastatic 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.

Active drug

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

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.

HealthScout AI summary: Men with hormone-sensitive oligometastatic prostate adenocarcinoma (1–3 SBRT-amenable lesions; prior definitive therapy; testosterone >125 ng/dL; PSA 0.5–50; PSADT <15 months; ECOG 0–2) receive metastasis-directed SBRT plus adenosine-axis modulation with quemliclustat (CD73 inhibitor) and etrumadenant (A2A/A2B receptor antagonist) followed by PD-1 blockade with zimberelimab. Aims to improve biochemical and radiographic control versus historical SBRT alone while deferring ADT.

ClinicalTrials.gov ID: NCT05915442