Clinical Trials for Prostate Cancer

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.

HealthScout 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.

HealthScout 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 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

HealthScout 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.

HealthScout 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.

HealthScout 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

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART): Adaptive Clinical Treatment (ACT)

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: This trial enrolls adults with advanced sarcoma, prostate, breast, ovarian, or pancreatic cancers who have progressed after prior systemic therapy, assigning individualized regimens—including targeted agents like CDK4/6 inhibitors (abemaciclib), PARP inhibitors (olaparib), EGFR inhibitors (gefitinib, osimertinib), endocrine therapies, and chemotherapeutics—based on serial molecular profiling and multidisciplinary tumor board review. Patients may switch treatments upon progression or toxicity according to ongoing molecular and proteomic data.

ClinicalTrials.gov ID: NCT06630325

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

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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