Clinical Trials for Prostate Cancer

An Open-label, Multicenter, Dose Escalation, and Dose Expansion Phase 1/2 Study With Peluntamig (PT217) Followed by a Key ChemotherapY and/or Checkpoint Inhibitor ComBination in Patients With NeuRoendocrIne Carcinomas That Are Known to be DLL3 expressinG CancErs (SKYBRIDGE)

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.

TrialFetch AI summary: Adults with DLL3-expressing advanced/metastatic neuroendocrine carcinomas (including SCLC, LCNEC, and extrapulmonary NEC; predominant ≥50% neuroendocrine component) receive peluntamig (PT217), a bispecific anti-DLL3/CD47 IgG designed to promote macrophage phagocytosis and ADCC, as monotherapy or combined with carboplatin/etoposide, paclitaxel, and/or atezolizumab. Cohorts include relapsed/refractory disease and line-specific settings such as platinum-sensitive second line and ES-SCLC first-line or post-induction with atezolizumab.

ClinicalTrials.gov ID: NCT05652686

A Phase 1, Open-Label, Multicenter, Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 in Patients With Advanced or Metastatic 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.

TrialFetch AI summary: Adults with metastatic prostate adenocarcinoma (ECOG 0–1) post–second-generation AR therapy and typically post-taxane (or ineligible/refusing), with PARP inhibitor exposure if BRCA1/2-mutated, receive oral RO7656594 (GDC-2992), a heterobifunctional androgen receptor antagonist/degrader via cereblon-mediated proteasomal degradation. Dose escalation and expansion assess safety, PK, and preliminary activity, excluding prior AR degrader exposure and untreated CNS disease.

ClinicalTrials.gov ID: NCT05800665

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

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.

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: Enrolling adults with metastatic rare genitourinary cancers across multiple histologic cohorts (e.g., small cell/neuroendocrine bladder, variant urothelial, penile, sarcomatoid/unclassified RCC, collecting duct, renal medullary, urethral; including a bone-only GU cohort), with up to two prior lines allowed (cohort-specific exceptions. Patients receive cabozantinib (MET/VEGFR2/AXL multi-kinase inhibitor) plus nivolumab (PD-1) and ipilimumab (CTLA-4) for up to 2 years.

ClinicalTrials.gov ID: NCT03866382

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.

TrialFetch 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

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.

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: 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.

TrialFetch 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

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.

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 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 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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