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.

TrialFetch AI summary: Patients with metastatic castration-resistant prostate adenocarcinoma previously treated with an androgen receptor pathway inhibitor and no or mild cancer-related symptoms are randomized to oral gridegalutamide (BMS-986365) or investigator’s choice of docetaxel or a second androgen receptor pathway inhibitor. Gridegalutamide promotes cereblon-dependent androgen receptor degradation and blocks signaling through remaining receptors.

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.

TrialFetch AI summary: This trial enrolls patients with mCRPC progressing despite androgen deprivation or orchiectomy and one or two prior androgen receptor pathway inhibitors, without prior taxane chemotherapy for mCRPC. Patients receive either ifinatamab deruxtecan, an investigational B7-H3–targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, or docetaxel plus prednisone.

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.

TrialFetch AI summary: Adults with progressive mCRPC after at least one androgen receptor-directed therapy and exactly one taxane regimen for mCRPC are randomized to xaluritamig or investigator-selected cabazitaxel, abiraterone, or enzalutamide. Xaluritamig is an investigational bispecific T-cell engager that binds STEAP1 on prostate cancer cells and CD3 on T cells.

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.

TrialFetch AI summary: Adults with metastatic castration-resistant prostate adenocarcinoma progressing after abiraterone, without prior enzalutamide or another next-generation androgen receptor inhibitor, are randomized to mevrometostat plus enzalutamide or physician’s choice of enzalutamide or docetaxel. Mevrometostat inhibits EZH2, an epigenetic enzyme involved in gene repression.

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.

TrialFetch AI summary: Adults with progressive metastatic castration-resistant prostate cancer after an androgen receptor signaling inhibitor and generally a taxane are assigned treatment based on molecular profiling. Options are valemetostat, an EZH1/EZH2 inhibitor; carboplatin plus cabazitaxel; or physician-choice cabazitaxel, abiraterone plus prednisone, enzalutamide, or PSMA-targeted lutetium Lu 177 vipivotide tetraxetan.

ClinicalTrials.gov ID: NCT06632977

A Phase II Multicenter Trial of ESK981 in Patients With Select Solid Tumors

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.

TrialFetch AI summary: Adults with advanced pancreatic adenocarcinoma or adenosquamous carcinoma, pancreatic or gastrointestinal neuroendocrine neoplasms (Ki-67 >20%), or metastatic prostate cancer with neuroendocrine features after progression on or intolerance of standard therapy receive oral ESK981 in separate single-arm cohorts. ESK981 is an investigational kinase inhibitor targeting VEGFR-1, VEGFR-2, and Tie-2, with preclinical evidence of PIKfyve inhibition.

ClinicalTrials.gov ID: NCT05988918

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.

TrialFetch AI summary: This trial enrolls patients with progressive metastatic castration-resistant prostate adenocarcinoma who have not received systemic treatment for mCRPC or prior enzalutamide, apalutamide, darolutamide, or abiraterone. Patients receive enzalutamide plus either mevrometostat, an investigational EZH2 inhibitor, or placebo.

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.

TrialFetch AI summary: Men with metastatic castration-sensitive prostate cancer and ECOG performance status 0–1 are enrolled in separate cohorts based on homologous-recombination repair mutation status. Patients receive investigational saruparib, a PARP1-selective inhibitor that traps PARP1 on damaged DNA, or placebo with physician-selected abiraterone, darolutamide, or enzalutamide plus ongoing castration therapy.

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.

TrialFetch AI summary: Adults with PSMA-positive metastatic castration-resistant prostate cancer who progressed on or after lutetium-177–PSMA therapy, and previously received an androgen receptor pathway inhibitor and taxane chemotherapy, are randomized to AAA817 or investigator-selected standard of care. AAA817 ([225Ac]Ac-PSMA-617) is an investigational PSMA-targeted radioligand that delivers actinium-225 alpha radiation.

ClinicalTrials.gov ID: NCT06780670

A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants With Advanced 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.

TrialFetch AI summary: Adult men with metastatic castration-resistant or hormone-sensitive prostate cancer are eligible; the comparative cohorts generally require no prior androgen receptor pathway inhibitor, while a separate Japanese cohort allows prior exposure. Treatment compares intramuscular ASP5541, a long-acting abiraterone prodrug that inhibits CYP17-dependent androgen synthesis, with oral abiraterone acetate; both are given with prednisone/prednisolone in castration-resistant disease, while ASP5541 is given without a glucocorticoid in hormone-sensitive disease.

ClinicalTrials.gov ID: NCT07005154