Clinical Trials for Prostate Cancer

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

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

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

A Phase I, Open-label, Multi-center Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-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: Chemo‑naïve adults with PSMA‑positive metastatic castration‑resistant prostate cancer after progression on exactly one second‑generation ARPI (ECOG 0–1, adequate renal function) receive lutetium‑177 vipivotide tetraxetan (PSMA‑targeted beta‑emitting radioligand therapy) 7.4 GBq IV every 6 weeks for up to 12 cycles with continued androgen deprivation. Prior radioligand therapy, prior mCRPC chemotherapy, significant renal impairment, and use of targeted agents (e.g., PARP inhibitors) are excluded.

ClinicalTrials.gov ID: NCT06531499

177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan

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: Single-arm study of 177Lu-PSMA-617 radioligand therapy (targets PSMA to deliver beta-emitting lutetium-177) in adult men with PSMA-positive mCRPC who have extensive bone involvement presenting as a super scan on 99mTc bone scan, after at least one AR pathway inhibitor. Patients receive up to six IV cycles every ~6 weeks with dose-escalation to define optimal dosing in this previously excluded, heavily bone-dominant population.

ClinicalTrials.gov ID: NCT06972628

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.

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 (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

SPECTRA: Supraphysiological Androgen to Enhance Treatment Activity

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 mCRPC progressing on next‑generation AR pathway inhibitors (maintained on ADT; no prior chemo for mCRPC) receive bipolar androgen therapy with supraphysiologic testosterone combined with either carboplatin, etoposide, or 177Lu‑PSMA‑617 (PSMA‑PET positive required for LuPSMA cohort), exploring synergy via DNA damage and PSMA modulation. Excludes patients with high VTE/cardiovascular risk or other contraindications to testosterone; outcomes focus on PSA50 response and disease control.

ClinicalTrials.gov ID: NCT06039371

A Phase 1b Study Evaluating Combinations With PSCA-Targeting Chimeric Antigen Receptor (CAR)-T Cells for Patients With PSCA+ Metastatic Castration-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 PSCA-expressing metastatic castration-resistant prostate cancer after at least one next-generation AR pathway inhibitor receive lymphodepleting chemotherapy followed by autologous PSCA-directed CAR T cells (4-1BB/CD3ζ with CD19t tag), with an optional cohort adding metastasis-directed radiation (16 Gy in 2 fractions) before lymphodepletion. Key aims are safety/feasibility and preliminary activity, with allowance for up to three CAR T infusions per course.

ClinicalTrials.gov ID: NCT05805371