Clinical Trials for Prostate Cancer

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.

HealthScout 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.

HealthScout 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.

HealthScout 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

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

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.

HealthScout AI summary: Men with biochemical recurrence after prostatectomy, ECOG 0–2, candidates for salvage prostate bed/pelvic nodal RT and short-term ADT, are randomized by PET status: PET-negative receive standard salvage EBRT + 6 months ADT with or without 6 months apalutamide (androgen receptor inhibitor); PET-positive receive the same intensified systemic therapy with apalutamide with or without metastasis-directed RT to PET-avid extrapelvic sites. Primary endpoint is progression-free survival.

ClinicalTrials.gov ID: NCT04423211

A Phase Ib Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer (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.

HealthScout AI summary: Men with mCRPC (ECOG 0–1) post–novel hormonal therapy and with PSMA-positive disease receive 177Lu-PSMA-617 combined with oral cabozantinib, a multi–tyrosine kinase inhibitor (targets MET/VEGFR2/AXL/RET) to assess safety and preliminary efficacy. Excludes prior PSMA RLT or cabozantinib and patients with significant cardiovascular, bleeding, CNS, or GI risk.

ClinicalTrials.gov ID: NCT05613894

A Phase IIA Study of Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive 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.

HealthScout AI summary: Adults with newly metastatic, castration-sensitive prostate adenocarcinoma (ECOG 0–1) who achieve a >50% PSA decline to <4 ng/mL after a short run-in receive an adaptive regimen combining an LHRH analog (medical castration), an androgen receptor signaling inhibitor (AR blockade), and docetaxel (microtubule inhibitor). Excludes prior next‑generation AR pathway inhibitors and visceral (liver/brain) metastases; treatment sequencing is individualized to prolong the castration‑sensitive phase.

ClinicalTrials.gov ID: NCT06734130

A Phase II, Open-label, Multi-Center, Randomized Study Comparing the Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (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.

HealthScout AI summary: PSMA PET–positive mCRPC patients with ECOG 0–2 who progressed after exactly one prior second-generation ARPI given before the mCRPC setting; excludes prior PSMA RLT or taxane in CRPC and those appropriate for PARP inhibitors due to HRR mutations. Randomizes to lutetium-177 vipivotide tetraxetan (PSMA-targeted beta-emitting radioligand therapy) plus an ARPI (enzalutamide or abiraterone) versus lutetium-177 vipivotide tetraxetan alone as first-line mCRPC treatment.

ClinicalTrials.gov ID: NCT06894511

A Phase I/II Study of M9241 With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and M9241 With Docetaxel in 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.

HealthScout AI summary: Adults with metastatic prostate cancer: mCSPC within ~4 months of starting ADT (high-volume for expansion) receive ADT + docetaxel + abiraterone/prednisone, with addition of M9241 (NHS‑IL12), a tumor-targeted IL‑12 immunocytokine that binds exposed histones to deliver IL‑12 to the tumor microenvironment. mCRPC patients previously treated with a modern ARSI (but not progressed on prior mCSPC docetaxel) receive docetaxel/prednisone plus M9241 from cycle 2 onward.

ClinicalTrials.gov ID: NCT04633252

Phase II Study of Talazoparib With Androgen Deprivation Therapy and Abiraterone in Castration Sensitive 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.

HealthScout AI summary: Metastatic castration-sensitive prostate cancer in men receiving standard ADT plus abiraterone/prednisone, adding talazoparib (a PARP inhibitor targeting DNA damage repair) to enhance disease control irrespective of homologous recombination repair status. Excludes prior chemo for metastatic disease; allows recent initiation of LHRH therapy and prior adjuvant ADT with testosterone recovery.

ClinicalTrials.gov ID: NCT04734730

Metastasis-directed Radiotherapy (MDRT) for Men With De-novo Oligometastatic Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)

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 newly diagnosed de-novo oligometastatic prostate adenocarcinoma (ECOG 0–1) receiving 12 months of standard systemic therapy (ADT ± ARSI) plus definitive prostate-directed therapy are randomized to add metastasis-directed radiotherapy (stereotactic/hypofractionated RT to all metastatic sites by week 24) versus standard care alone. Excludes castration-resistant disease, visceral/intracranial metastases, prior definitive local/systemic therapy, and significant comorbidities.

ClinicalTrials.gov ID: NCT06150417