Clinical Trials for Prostate Cancer

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

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

Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated 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.

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: This trial enrolls adults with recurrent or second primary tumors in body sites previously treated with radiotherapy—including CNS, head and neck, breast, thoracic, GI, GU, and gynecological cancers—to evaluate reirradiation using pencil beam scanning proton therapy, which aims to provide effective tumor control with reduced toxicity compared to standard photon techniques. No investigational drugs are included, and some cohorts may not allow concurrent chemotherapy.

ClinicalTrials.gov ID: NCT05313191

A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage 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.

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: This trial enrolls adults with advanced or metastatic solid tumors harboring deleterious germline or somatic DNA damage response (DDR) gene aberrations who have progressed after standard therapy, including those with prior platinum or PARP inhibitor exposure. Patients receive oral talazoparib, a PARP1/2 inhibitor that exploits defective DNA repair in cancer cells, administered daily in 28-day cycles until disease progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT04550494

AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation

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 unresectable or metastatic solid tumors harboring the AKT1 E17K mutation who have not previously received PI3K or mTOR inhibitors and have good performance status. The study tests ALTA2618, an oral, mutation-selective covalent allosteric inhibitor of AKT1 E17K.

ClinicalTrials.gov ID: NCT06533059

A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

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.

TrialFetch AI summary: This trial enrolls adults with previously treated, castration-sensitive oligometastatic prostate adenocarcinoma (1-5 PET-detected bone or nodal/soft tissue metastases, including at least one extrapelvic), randomizing them to stereotactic ablative body radiation therapy (SABR) plus either relugolix (an oral GnRH receptor antagonist) or placebo for 6 months.

ClinicalTrials.gov ID: NCT05053152

Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC) (BAT-RAD Study)

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.

TrialFetch AI summary: Men with mCRPC with bone-predominant disease, asymptomatic/minimally symptomatic, castrate testosterone, prior exposure to ≤1 novel AR-targeted agent (and no visceral metastases) receive radium-223 plus Bipolar Androgen Therapy (testosterone cypionate). Radium-223 is an alpha-emitting bone-targeted radiopharmaceutical, and BAT cycles supraphysiologic testosterone to induce DNA damage and potentially re-sensitize AR signaling.

ClinicalTrials.gov ID: NCT04704505

LuCarbo - a Phase 1a/1b Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer

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.

TrialFetch AI summary: Adults with progressive mCRPC post–ARPI and taxane, ECOG 0–2, PSMA-avid on 68Ga-PSMA PET, receive 177Lu-PSMA-617 radioligand therapy (targets PSMA to deliver beta radiation) combined with carboplatin DNA–crosslinking chemotherapy; prior PARPi/Ra-223 allowed, prior 177Lu-PSMA-617 excluded. Single-arm dose-escalation/expansion evaluates safety and preliminary efficacy, with carboplatin Days 1/22 and 177Lu-PSMA-617 Day 2 every 6 weeks for up to 6 cycles.

ClinicalTrials.gov ID: NCT06303713

A Phase II Randomized Study of Sipuleucel-T With or Without Continuing New Hormonal Agents (NHA) in Metastatic Prostate Cancer With PSA Progression While on NHA and LHRH Analog

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.

TrialFetch AI summary: Asymptomatic or minimally symptomatic mCRPC patients with PSA-only progression on continuous ADT plus a new hormonal agent (abiraterone, enzalutamide, or apalutamide) and no visceral disease are randomized to receive sipuleucel‑T with the NHA continued versus stopped. Sipuleucel‑T is an autologous cellular immunotherapy activating APCs ex vivo with a PAP–GM‑CSF fusion protein; NHAs include the androgen biosynthesis inhibitor abiraterone (with prednisone) and AR signaling inhibitors enzalutamide/apalutamide.

ClinicalTrials.gov ID: NCT05751941