Clinical Trials for Prostate Cancer

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.

HealthScout AI summary: ARPI‑naïve men with metastatic castration‑resistant or hormone‑sensitive prostate cancer (plus a Japanese safety cohort) receive long‑acting intramuscular abiraterone decanoate (ASP5541), a CYP17A1 inhibitor prodrug dosed about every 12 weeks, with or without prednisone/prednisolone, compared against standard daily oral abiraterone acetate with corticosteroid. Key comparisons include PSA responses in mCRPC and activity/safety (including mineralocorticoid toxicity) in mHSPC.

ClinicalTrials.gov ID: NCT07005154

A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination With Standard of Care Versus Standard of Care Alone in Patients With PSMA Positive Metastatic Castration-Resistant Prostate Cancer Previously After Androgen Receptor Pathway Inhibitor Treatment

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‑positive mCRPC after progression on ≥12 weeks of an ARPI, ECOG 0–2, and adequate organ function; excludes prior PSMA‑targeted therapy, recent radioisotopes, PARP inhibitors, and chemotherapy for mCRPC (docetaxel in mCSPC allowed). Randomizes to 177Lu‑TLX591 (rosopatamab tetraxetan), a PSMA‑targeted beta‑emitting radioimmunotherapy, plus SOC (enzalutamide, abiraterone/prednisone, or docetaxel/prednisone) versus SOC alone.

ClinicalTrials.gov ID: NCT06520345

PRO-XL: A Phase II Study of XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer After Progression on Lutetium-177 (177Lu)-PSMA-617

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 radiographic mCRPC who have progressed after 177Lu‑PSMA‑617 receive oral zanzalintinib (XL092) monotherapy once daily. XL092 is an investigational multikinase TKI targeting VEGFR2, MET, and TAM kinases (TYRO3/AXL/MER) to inhibit angiogenesis and tumor growth; primary endpoint is 16‑week disease control.

ClinicalTrials.gov ID: NCT06568562

A Phase 2, Single-Arm Study of the CXCR1/2 Inhibitor SX-682 Plus Enzalutamide in Men With Abiraterone-Resistant Metastatic Castration Resistant Prostate Cancer, the SYNERGY-201 Trial

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 mCRPC who have progressed on abiraterone (without prior enzalutamide/apalutamide/darolutamide or recent radionuclide therapy) receive enzalutamide plus SX-682, an oral CXCR1/2 inhibitor that blocks MDSC trafficking to modulate the tumor microenvironment. Key exclusions include liver metastases, significant CV disease, active autoimmune/infectious disease, and use of strong CYP3A4 modulators or QT‑prolonging drugs.

ClinicalTrials.gov ID: NCT06228053

A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

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: Adult men with high‑volume metastatic hormone‑sensitive prostate adenocarcinoma (ECOG 0–2, castrate testosterone) are randomized to luxdegalutamide (JSB462), an oral PROTAC androgen receptor degrader, plus abiraterone (two dose levels) versus standard ARPI therapy (abiraterone or enzalutamide). Prior second‑generation ARPI for advanced/metastatic disease is excluded; limited prior (neo)adjuvant therapy allowed if completed >12 months before randomization.

ClinicalTrials.gov ID: NCT06991556

A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant 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 mCRPC limited to bone and/or nodes (no visceral disease) who have progressed after ARPI, two taxanes (unless not feasible), PSMA-lutetium if available/appropriate, and PARP inhibitor if BRCA-mutated receive pasritamig plus best supportive care versus placebo plus best supportive care. Pasritamig is an investigational KLK2×CD3 bispecific T‑cell–redirecting antibody designed to target prostate-restricted KLK2 and engage T cells; ongoing ADT required, ECOG 0–2.

ClinicalTrials.gov ID: NCT07164443

A Phase II Study of Sequential Bipolar Androgen Therapy and ZEN-3694 in Sequence With Enzalutamide + ZEN-3694 in Asymptomatic Patients With Metastatic CRPC: The COSMYC Trial (COmbined Suppression of MYC)

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: Asymptomatic men with metastatic castration‑resistant prostate cancer progressing after a next‑generation AR inhibitor (with ongoing ADT; prior taxane/PARP/radiopharmaceuticals allowed) receive sequential therapy starting with high‑dose testosterone plus the BET inhibitor ZEN‑3694 (targets BRD2/3/4/BRDT to suppress MYC/AR signaling), then transition at radiographic progression to enzalutamide plus ZEN‑3694. Aims to enhance disease control and potentially resensitize tumors to AR‑targeted therapy; key labs/organ function required, ECOG 0–2, PSA ≥1 ng/mL.

ClinicalTrials.gov ID: NCT06922318

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (MEVPRO-3)

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) who are ARPI- and chemotherapy-naïve in the mCSPC setting (allowing up to 3 months of ADT/first-generation antiandrogen) are randomized to enzalutamide plus the EZH2 inhibitor mevrometostat (PF-06821497) versus enzalutamide alone. Investigational agent mechanism: selective EZH2 (PRC2) inhibition to reduce H3K27 methylation and re-express silenced tumor suppressor genes.

ClinicalTrials.gov ID: NCT07028853

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant 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: Chemotherapy-naïve mCRPC adults (ECOG 0–1) who progressed on exactly one prior AR pathway inhibitor (enzalutamide, apalutamide, or darolutamide) and remain on castration are randomized to xaluritamig plus abiraterone versus investigator’s choice of abiraterone, docetaxel, or cabazitaxel. Xaluritamig (AMG 509) is a STEAP1×CD3 bispecific T‑cell engager designed to redirect T‑cell cytotoxicity; exclusions include prior abiraterone progression, prior STEAP1 therapy, mCRPC chemo, significant prior radionuclide/PSMA therapy, and neuroendocrine histology.

ClinicalTrials.gov ID: NCT07213674

A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)

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 next‑generation hormonal agent and 1–2 taxane regimens (ECOG 0–1) are randomized to the CYP11A1 inhibitor opevesostat (with physiologic steroid replacement) versus switching to abiraterone/prednisone or enzalutamide; efficacy will be evaluated separately in AR ligand‑binding domain mutation–positive and –negative cohorts. Prior PARP inhibitor or 177Lu‑PSMA‑617 is allowed; key exclusions include significant cardiovascular, thromboembolic, seizure, or endocrine risks and drug–drug interactions.

ClinicalTrials.gov ID: NCT06136624