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

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic 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

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.

HealthScout AI summary: Adults with measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

ClinicalTrials.gov ID: NCT06172478

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

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

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.

HealthScout AI summary: Adults with advanced/metastatic solid tumors (endometrial, gastric, mCRPC, ovarian, colorectal, urothelial, biliary) receive datopotamab deruxtecan (anti‑TROP2 antibody–drug conjugate delivering a topoisomerase I inhibitor) as monotherapy or combined with agents such as capecitabine/5‑FU, bevacizumab ± platinum, prednisone (mCRPC), platinum in urothelial cancer, or bispecific PD‑1/CTLA‑4 (volrustomig) or PD‑1/TIGIT (rilvegostomig) immunotherapies. Key exclusions include active/untreated CNS disease, prior TROP2- or deruxtecan-based ADCs, significant ILD/pneumonitis history, and uncontrolled infections/comorbidities.

ClinicalTrials.gov ID: NCT05489211

A Phase 2, Open-label Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive 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

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.

HealthScout AI summary: PSMA PET–positive metastatic castration‑resistant prostate cancer on continuous ADT after ≥1 ARSI; no PSMA‑negative lesions, with Part 3 requiring prior Lu‑177–PSMA (and allowing ≤1 prior taxane). Investigational therapy is Ac‑225 rosopatamab tetraxetan (225Ac‑J591), a PSMA‑targeted alpha‑emitting monoclonal antibody delivered in a single fractionated cycle (Day 1/15) at 45–60 kBq/kg, with randomized dose optimization in PSMA‑RT–naive patients and dose escalation/expansion in those post‑Lu‑177.

ClinicalTrials.gov ID: NCT06549465

A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With 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.

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.

HealthScout AI summary: Men with metastatic castration-resistant prostate cancer progressing on abiraterone (ECOG 0–1, on continuous ADT, no prior second‑generation AR inhibitor or mCRPC chemotherapy) are randomized to enzalutamide alone versus enzalutamide plus ZEN003694, an oral pan-BET bromodomain inhibitor (BRD2/3/4/BRDT) aiming to suppress AR/MYC-driven transcription. Two predefined cohorts (poor vs good prior abiraterone responders) are included; crossover from control at radiographic progression is allowed.

ClinicalTrials.gov ID: NCT04986423

A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Lutetium (177Lu) Vipivotide Tetraxetan in Adult Male Patients With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)

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

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.

HealthScout AI summary: PSMA-positive mCRPC after at least one ARPI (and up to two taxanes), no prior PSMA radioligand therapy, randomized to 177Lu-PSMA-617 alone or combined with JSB462 (luxdegalutamide), an oral PROTAC androgen receptor degrader active against LBD resistance mutations. Aims to assess whether adding JSB462 improves antitumor activity and safety versus radioligand alone.

ClinicalTrials.gov ID: NCT07047118