Clinical Trials for Prostate Cancer

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 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

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

A Randomized Phase II Study Comparing Sequential High Dose Testosterone and Enzalutamide to Enzalutamide Alone in Asymptomatic Men With Castration Resistant Metastatic 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.

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 men with mCRPC progressing on abiraterone plus ongoing ADT (testosterone <50 ng/dL), ECOG 0–2, and no prior AR antagonists or CRPC chemotherapy are randomized to continuous enzalutamide vs alternating cycles of supraphysiologic testosterone cypionate (bipolar androgen therapy; induces AR feedback disruption/DNA damage with potential AR re-sensitization) and enzalutamide, including a PSA-driven switching arm. Continues until clinical or radiographic progression; excludes patients with cancer-related pain, high thromboembolic risk, or conditions that increase risk from testosterone.

ClinicalTrials.gov ID: NCT04363164

AtezoCab: A Phase II Study of Cabozantinib in Combination With Atezolizumab in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Non-Measurable Disease

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: Enrolling men with metastatic castration-resistant prostate cancer characterized by non-measurable disease (often bone-predominant) after at least one novel hormonal agent, ECOG 0–2, and no prior PD-(L)1, CTLA-4, cabozantinib, or mCRPC chemotherapy. Patients receive cabozantinib (multi-kinase TKI targeting MET/VEGFR2/AXL) daily plus atezolizumab (anti–PD-L1) IV every 21 days until progression/toxicity.

ClinicalTrials.gov ID: NCT05168618