Clinical Trials for Prostate Cancer

Minority-Inclusive Imaging Biomarker-Based End of Therapy Trial for 177Lu-PSMA-617, a Randomized De-Escalation Theranostic Trial for Metastatic Castrate 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.

HealthScout AI summary: Adults with PSMA-positive metastatic castration-resistant prostate cancer at Mayo Clinic Rochester who achieve a near-complete response on post-therapy SPECT after initial 177Lu-PSMA-617 are randomized to continue standard 177Lu-PSMA-617, pause after 5 cycles with retreatment at progression, or initial observation with deferred 177Lu-PSMA-617 at first progression. 177Lu-PSMA-617 is a PSMA-targeted radioligand therapy delivering beta radiation to PSMA-expressing cells; the trial tests whether imaging-guided de-escalation maintains disease control while reducing exposure.

ClinicalTrials.gov ID: NCT06200103

Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes

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-sensitive prostate adenocarcinoma starting or on first-line intensified ADT (abiraterone, apalutamide, enzalutamide, or darolutamide; with or without prior chemotherapy) are randomized to monthly 5-day fasting-mimicking diet vs standard diet added to standard-of-care. Evaluates impact on PSA response and metabolic outcomes; excludes underweight patients, unstable diabetes, significant comorbidities, recent major weight loss, or regular fasters.

ClinicalTrials.gov ID: NCT05832086

A Phase 1 Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced 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 prostate adenocarcinoma: mainly metastatic castration-resistant disease post–AR-targeted therapy (some cohorts require prior taxane or prior 177Lu-PSMA), plus a metastatic hormone-sensitive cohort including oligometastatic patients eligible for SBRT. Investigational therapy is JNJ-69086420 (alpitatug), an Actinium-225–labeled anti–hK2 radioimmunotherapy; given as monotherapy at escalating/expansion doses, with a combination cohort adding JNJ-78278343 (pasritamig), a KLK2×CD3 bispecific T-cell engager.

ClinicalTrials.gov ID: NCT04644770

A Single Arm Open-label, Phase II Study of Sipuleucel-T with Bipolar Androgen Therapy in Men 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.

HealthScout AI summary: Men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (ECOG 0–1, castrate testosterone) receive bipolar androgen therapy with intramuscular testosterone cypionate plus standard sipuleucel-T. Sipuleucel-T is an autologous APC-based vaccine activated ex vivo with PA2024 (PAP–GM-CSF) and BAT provides cyclical supraphysiologic testosterone to stress tumor cells; the study targets immunologic enhancement and assesses PSA/radiographic outcomes.

ClinicalTrials.gov ID: NCT06100705

An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune 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.

HealthScout AI summary: Men with asymptomatic or minimally symptomatic metastatic castrate‑resistant prostate cancer who have completed the standard three infusions of sipuleucel‑T (PROVENGE) are randomized to receive a single booster sipuleucel‑T infusion at 6–9 months versus no booster. Sipuleucel‑T is an autologous cellular immunotherapy activating APCs with a PAP–GM‑CSF fusion protein (PA2024); the study assesses boosted immune responses and clinical outcomes, including overall survival.

ClinicalTrials.gov ID: NCT06134232

Efficacy of Ra-223 in PSMA PET Optimally Selected Patients

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 PSMA PET–positive, bone-predominant mCRPC (no visceral disease) after at least one AR pathway inhibitor and minimal prior taxane exposure receive radium-223 dichloride IV every 28 days for 6 cycles. Radium-223 is an alpha-emitting calcium mimetic targeting osteoblastic metastases to deliver localized high-LET radiation; primary outcome is PSA50 response, with secondary survival, skeletal event, imaging, and safety endpoints.

ClinicalTrials.gov ID: NCT05924672

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

A Master Protocol for the Multi-Cohort, Open-Label, Phase 1/2 Study of DCC-3084 as Monotherapy and in Combination With Other Antitumor Agents in Participants With Advanced Malignancies Driven by the MAPK Pathway

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 or metastatic solid tumors driven by MAPK pathway alterations (KRAS, HRAS, NRAS, BRAF, CRAF, or NF1), who have exhausted standard therapies and have good performance status, to receive the investigational oral MAPK pathway inhibitor DCC-3084 as monotherapy or in combination with other antitumor agents. Confirmed BRAF mutations are required for participation in certain cohorts.

ClinicalTrials.gov ID: NCT06287463

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