Clinical Trials for Prostate Cancer

A Phase I Clinical Trial of an Infusion of Autologous Gamma Delta T Cells Genetically Engineered With a Chimeric Receptor to Target the Prostate Stem Cell Antigen in Patients With Metastatic Castration Resistant Prostate Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Men with metastatic castration‑resistant prostate cancer predominantly to bone, previously treated with at least one taxane (or other chemotherapy) and one AR‑targeted agent, receive lymphodepletion (fludarabine/cyclophosphamide) followed by a single infusion of autologous γδ T cells engineered with a PSCA‑targeted CAR (CD28/CD3ζ), with protocol‑directed zoledronic acid to support γδ T‑cell activation and bone health. Single‑center, open‑label dose escalation/expansion; key exclusions include active viral infections, significant cardiac/autoimmune disease, unstable CNS metastases, and contraindication to zoledronic acid.

ClinicalTrials.gov ID: NCT06193486

An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With 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.

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 PSMA-positive metastatic castration-resistant prostate cancer: Phase 1 enrolls post-NAAD and after 1–2 taxane lines; Phase 2 enrolls post-NAAD without prior mCRPC taxanes. Investigational therapy is 177Lu-rhPSMA-10.1, a PSMA-targeted beta-emitting radioligand delivering lutetium-177 to tumor cells, given in various fixed-activity dosing regimens to define safety, dosimetry, and PSA response.

ClinicalTrials.gov ID: NCT05413850

An Open-label, Phase 1 Study of DCC-2812 Monotherapy in Participants With Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with advanced or metastatic renal cell carcinoma, urothelial carcinoma, or castration-resistant prostate cancer receive oral DCC-2812 monotherapy, a first-in-human, selective GCN2 activator that engages the integrated stress response (eIF2α phosphorylation/ATF4) to disrupt tumor survival pathways. Dose-escalation evaluates safety, dose-limiting toxicities, and PK, with preliminary antitumor activity assessed.

ClinicalTrials.gov ID: NCT06966024

Phase I/II Study of CDK4/6 Inhibition With Abemaciclib to Upregulate PSMA Expression Prior to 177Lu-PSMA-617 Treatment in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Chemotherapy

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 PSMA-avid metastatic castration-resistant prostate adenocarcinoma after prior AR-targeted therapy and taxane chemotherapy receive short-course abemaciclib (CDK4/6 inhibitor) lead-in to upregulate PSMA followed by 177Lu-PSMA-617 radioligand therapy, repeated every 6 weeks for up to 4 cycles. Key eligibility includes ECOG 0–2, maintained castrate testosterone, and no prior CDK4/6 inhibitors or PSMA-RLT.

ClinicalTrials.gov ID: NCT05113537

A Phase 1 Open-label, First-in-human, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Actinium-225-macropa-pelgifatamab (BAY 3546828) in Participants With Advanced Metastatic Castration Resistant Prostate Cancer (mCRPC)

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with PSMA‑positive metastatic castration‑resistant prostate adenocarcinoma (ECOG 0–1) after at least one AR‑targeted therapy, with cohorts defined by prior taxane and 177Lu‑PSMA exposure, receive IV actinium‑225–macropa–pelgifatamab (a PSMA‑targeted anti‑PSMA IgG1 radioconjugate delivering alpha radiation) in 42‑day cycles. Excludes PSMA‑negative dominant lesions and most prior radiopharmaceuticals (except defined 177Lu‑PSMA in one cohort).

ClinicalTrials.gov ID: NCT06052306

SatisfACtion: Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With mHSPC and Heavily Pre-treated PSMA-positive mCRPC, With/Without Prior 177Lu-labelled PSMA-targeted Radioligand Therapy

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Men with PSMA-positive metastatic prostate cancer (mHSPC or mCRPC), including cohorts post– or pre–177Lu-PSMA therapy, receive 225Ac-PSMA-R2, a PSMA-targeted alpha-emitting radioligand delivering high-LET radiation to PSMA-expressing tumor cells. Suitable for heavily pretreated mCRPC after ARPI/taxanes and 177Lu-PSMA, mCRPC pre-177Lu, and mHSPC with minimal prior systemic therapy.

ClinicalTrials.gov ID: NCT05983198

A Phase I/II Open Label Study to Evaluate the Safety, Cellular Kinetics, and Efficacy of AZD0754, a Chimeric Antigen Receptor (CAR) T-cell Therapy Directed Against STEAP2, in Adult Participants With Metastatic Prostate Cancer: APOLLO

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with metastatic castration‑resistant prostate adenocarcinoma after at least one AR‑targeted therapy and a taxane (and PARPi for BRCA1/2 or CPI for MSI‑H/dMMR as applicable) receive lymphodepletion followed by a single infusion of AZD0754, an autologous STEAP2‑targeted CAR T‑cell therapy armored with a dominant‑negative TGF‑βRII. Bridging therapy may be used during manufacturing; key exclusions include prior CAR‑T/STEAP2 therapy and brain metastases.

ClinicalTrials.gov ID: NCT06267729

A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with metastatic castration-resistant prostate adenocarcinoma after at least one novel hormonal agent and typically prior taxane therapy receive ABBV-969 monotherapy, an intravenous dual-targeting antibody–drug conjugate against PSMA and STEAP1 delivering a topoisomerase-1 inhibitor payload. Requires measurable/evaluable metastasis, castrate testosterone, adequate organ function; excludes significant cardiac/pulmonary disease and unresolved ≥Grade 2 toxicities.

ClinicalTrials.gov ID: NCT06318273

A Phase 1 and Phase 2, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with metastatic castration-resistant prostate adenocarcinoma after at least one taxane and one AR-targeted therapy receive oral INV-9956, a CYP11A1 inhibitor that blocks the first step of steroidogenesis to further suppress androgen signaling, given with mandatory dexamethasone and fludrocortisone replacement. Open-label dose escalation followed by expansion to define dose, safety, PK/PD, and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT06609005

A Phase I, Open-label, Multi-center Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with metastatic neuroendocrine prostate cancer (including adenocarcinoma with NE features) who are PSMA and/or SSTR2 and/or GRPR PET-positive receive target-selected lutetium-177 radioligand therapy: [177Lu]Lu-PSMA-617 for PSMA-predominant, [177Lu]Lu-DOTA-TATE for SSTR2-predominant, or investigational GRPR-targeted [177Lu]Lu-NeoB for GRPR-predominant disease, up to 6 cycles every 6 weeks with continued ADT as indicated. Aimed at assessing safety and early activity with serial target-specific PET/CT to confirm target engagement and changes in expression.

ClinicalTrials.gov ID: NCT06379217