Clinical Trials for Prostate Cancer

A Randomized Open-label Phase 2 Study of TALazoparib With or Without ENzaluTamide in Patients With Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate

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: Enrolling adults with mCRPC harboring pathogenic HRR mutations (e.g., BRCA1/2, ATM [≤15%], CDK12, CHEK2, PALB2, etc.) after progression on abiraterone, castrate testosterone, and ECOG 0–1; excludes prior PARP inhibitors/platinum and prior ARPI for CRPC other than abiraterone. Randomizes to talazoparib (PARP1/2 inhibitor) plus enzalutamide (androgen receptor inhibitor) versus talazoparib alone.

ClinicalTrials.gov ID: NCT06844383

Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

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 de novo or metachronous high-volume metastatic castration-sensitive prostate adenocarcinoma (M1 on conventional imaging; no PSMA-PET–only or N1-only disease) are randomized to ADT plus apalutamide versus ADT plus apalutamide with docetaxel (up to 6 cycles). Apalutamide is a second‑generation androgen receptor antagonist; docetaxel is a microtubule-stabilizing taxane, and the trial tests whether adding docetaxel to the ADT+apalutamide backbone improves overall survival, including in genomically defined subgroups (TP53/PTEN/RB1).

ClinicalTrials.gov ID: NCT06931340

A Phase II Randomized, Decentralized, De-escalation Study in Patients With Metastatic Hormone-Sensitive Prostate Cancer Achieving Optimal PSA Response (OPTIMAS)

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 hormone-sensitive prostate adenocarcinoma who achieve a deep PSA response (≤0.2 ng/mL) receive relugolix (oral GnRH receptor antagonist) plus an ARPI (abiraterone, enzalutamide, apalutamide, or darolutamide), with randomization to intermittent versus continuous therapy in newly treated patients and a single-arm intermittent strategy for those already suppressed. Aims to reduce fatigue and preserve disease control while characterizing outcomes and quality of life with intermittent ADT/ARPI.

ClinicalTrials.gov ID: NCT07216248

A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

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 adenocarcinoma on ADT for 6–12 months plus an AR pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide) for ≥4 months who have castrate testosterone but suboptimal PSA response (PSA ≥0.2 ng/mL) and no radiographic/clinical progression are randomized to continue ADT+ARPI versus add docetaxel IV chemotherapy (a taxane microtubule stabilizer that also disrupts androgen receptor trafficking/signaling). Key exclusions include prior taxane therapy, early castration-resistant PSA rise pattern, and significant neuropathy or hypersensitivity to polysorbate 80 formulations.

ClinicalTrials.gov ID: NCT06592924

Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)

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: Enrolling adults with castration-sensitive prostate adenocarcinoma and rising PSA who have de novo oligometastatic or hormone-sensitive oligoprogressive disease limited to ≤5 extrapelvic metastases on baseline PSMA-PET (no brain/liver mets) and are candidates for ablative-intent metastasis-directed radiotherapy to all sites (with primary controlled or treated). Patients receive stereotactic/ablative RT with cohort-based systemic therapy options (ADT ± an androgen receptor signaling inhibitor, or RT alone if declining systemic therapy), with serial flotufolastat F 18 PSMA-PET and ctDNA used to monitor response and detect progression.

ClinicalTrials.gov ID: NCT07210086

A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant 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.

TrialFetch AI summary: Adults with progressive metastatic castration-resistant prostate adenocarcinoma (no neuroendocrine/small-cell features), ECOG 0–1, after progression on exactly one prior second-generation AR pathway inhibitor and with FoundationOne CDx–selected PI3K-pathway biomarker/tissue available (excluding liver metastases and abnormal baseline glycemia/diabetes). Randomized to inavolisib (oral selective PI3Kα inhibitor) plus enzalutamide versus physician’s choice of alternate ARPI (abiraterone or enzalutamide) or docetaxel.

ClinicalTrials.gov ID: NCT07287150

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Via Modulation of ANdrogen Receptor (the SPIDERMAN Trial)

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: Enrolls treatment-naïve men with metastatic hormone-sensitive prostate adenocarcinoma who start 6 months of ADT plus darolutamide, an androgen receptor inhibitor, and must have no progression and at least a 50% PSA decline to continue. Responders receive alternating 12-week cycles of supraphysiologic testosterone cypionate bipolar androgen therapy and darolutamide alone to test whether cycling androgen signaling delays clinical or radiographic progression.

ClinicalTrials.gov ID: NCT07142551

A Phase 2a Study of High Dose Testosterone Followed by Targeted Radioligand Therapy in Metastatic Castration Resistant 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.

TrialFetch AI summary: Single-arm study for men with PSMA PET–positive mCRPC, ECOG 0–1, minimal cancer-related symptoms, and limited prior mCRPC therapy (≤1 androgen receptor pathway inhibitor; prior sipuleucel-T and castration-sensitive docetaxel allowed), excluding liver/brain/epidural metastases. Patients continue ADT and receive high-dose testosterone cypionate as bipolar androgen therapy followed by PSMA-617 radioligand therapy, a PSMA-targeted radiation-delivery agent.

ClinicalTrials.gov ID: NCT07476001

Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic 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.

TrialFetch AI summary: Adults with progressive metastatic castration-resistant prostate adenocarcinoma after androgen-receptor pathway therapy and prior taxane therapy, or taxane ineligibility/refusal, receive two 8-week cycles of 225Ac-J591, a PSMA-targeted alpha-emitting antibody, plus either 177Lu-PSMA-I&T or 177Lu-PSMA-617, PSMA-targeted beta-emitting small-molecule radioligands. Selected patients with prior 177Lu-PSMA exposure may be eligible.

ClinicalTrials.gov ID: NCT04886986

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors

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

TrialFetch AI summary: Eligible patients are adults with select advanced or metastatic solid tumors (including colorectal, cholangiocarcinoma, appendiceal, pancreatic, gastric, endometrial, triple negative breast, ovarian, or prostate cancers) who have exhausted standard therapies; phase 2 focuses on colorectal cancer. Therapy is with APL-5125, an oral CK2α kinase inhibitor targeting Wnt signaling.

ClinicalTrials.gov ID: NCT06399757