Clinical Trials for Prostate Cancer

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

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.

TrialFetch 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

A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of [225Ac]Ac-FL-020 in Participants With 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.

TrialFetch AI summary: Adults with PSMA-positive metastatic castration-resistant prostate cancer after ARSI/CYP17 inhibitor and typically 1–2 taxanes receive intravenous [225Ac]Ac-FL-020, a PSMA-targeted alpha-emitting radiopharmaceutical delivering actinium-225 to induce DNA double-strand breaks. Single-arm dose-escalation/expansion assesses safety, PK/dosimetry (with [111In]In-FL-020 in a subset), and preliminary activity.

ClinicalTrials.gov ID: NCT06492122

A Phase 1 Open-label, First-in-human, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of 225Ac-PSMA-Trillium 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.

TrialFetch AI summary: Adults with PSMA-PET–positive metastatic castration‑resistant prostate adenocarcinoma (ECOG 0–1) after at least one novel androgen‑axis therapy and taxane exposure per cohort (including a cohort post–177Lu‑PSMA) receive IV 225Ac‑PSMA‑Trillium every 6 weeks up to 4 cycles. 225Ac‑PSMA‑Trillium is a PSMA-targeted small‑molecule alpha radioligand (actinium‑225, macropa chelator with albumin‑binding moiety) designed to enhance tumor uptake and limit salivary exposure by delivering alpha radiation–mediated DNA damage.

ClinicalTrials.gov ID: NCT06217822

A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC)

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 cancer who have progressed on or are intolerant to at least one next-generation hormonal agent and taxane receive ACE-232, an oral non-steroidal CYP11A1 inhibitor that suppresses steroidogenesis to reduce AR signaling. Single-arm, dose-escalation and dose-optimization cohorts are included, with a biomarker-enriched Phase 1B focusing on patients with AR gene alterations.

ClinicalTrials.gov ID: NCT06801236

A Phase 1/2 First-Time-In-Human, Open-Label, Multicenter, Dose Escalation and Expansion Study of GSK5458514 PSMA Targeting T Cell Engager Alone or in Combination With Other Anti-Cancer Agents in Adult Participants With 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.

TrialFetch AI summary: Adults with metastatic castration-resistant prostate adenocarcinoma after at least one novel AR-targeted therapy and 1–2 taxane regimens (ECOG 0–1) receive GSK5458514, a PSMA×CD3 bispecific T‑cell engager redirecting T‑cell cytotoxicity to PSMA-expressing tumors, as monotherapy with possible combination cohorts. Excludes neuroendocrine variants, CNS metastases, prior PSMA CAR‑T/engagers, recent extensive PSMA radioligand therapy, significant autoimmune disease, or active viral hepatitis.

ClinicalTrials.gov ID: NCT06990880

Phase 1/2 Study of HLD-0915 in Patients With 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.

TrialFetch AI summary: Eligible adult men with progressive mCRPC on continuous ADT after prior systemic therapy (ECOG 0–1) receive oral HLD‑0915 monotherapy in 21‑day cycles. HLD‑0915 is a first‑in‑class RIPTAC small molecule that leverages androgen receptor as a tumor handle to recruit BRD4 (AR–BRD4 RIPTAC), inducing selective cancer cell death; exclusions include neuroendocrine/small‑cell features and significant bleeding or cardiac disease.

ClinicalTrials.gov ID: NCT06800313

Open-label Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System (Interstitial Multiple Diode Lasers and IDOSE® Software) and Verteporfin for Injection (VFI) for the Treatment of Recurrent 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 localized, histologically confirmed intraprostatic recurrence after prior external-beam or HDR brachytherapy (ECOG 0–1, no nodal/metastatic disease) undergo interstitial photodynamic therapy using the SpectraCure P18 laser with IDOSE planning plus verteporfin. Verteporfin is a benzoporphyrin photosensitizer that accumulates in tumor/neovasculature and, when light-activated, generates reactive oxygen species to induce vascular shutdown and tumor necrosis; patients unsuitable for salvage surgery or curative re-irradiation are eligible.

ClinicalTrials.gov ID: NCT03067051

A Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 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: Adults with metastatic castration-resistant prostate cancer (adenocarcinoma or neuroendocrine variants), ECOG 0–1, are enrolled to receive a STEAP2-targeted theranostic: imaging with radiolabeled AZD2287 (± cold antibody AZD2275 pre-dose) followed by dose-escalated [225Ac]-AZD2284, an actinium-225–labeled anti-STEAP2 monoclonal antibody delivering alpha radiation to STEAP2-expressing tumors. Key exclusions include recent radiopharmaceuticals/therapy and significant comorbidities; outcomes focus on safety, dosimetry, biodistribution, and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT06879041