At a glance
ClinicalIndex Comparison Record- ✓Male, at least 18 years old
- ✓Histologically confirmed prostate adenocarcinoma
- ✓Progressive metastatic CRPC by PCWG3 criteria (PSA progression, radiographic progression, or new bone lesions)
- ✓Evaluable for response: measurable disease by RECIST 1.1, detectable CTC >0, or PSA ≥2 ng/dL
- ✕Prior chemotherapy for CRPC (docetaxel in hormone-sensitive setting acceptable if ≥6 months since last dose)
- ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, CTLA-4, OX40, or CD137 agents
- ✕Active autoimmune disease requiring systemic treatment in past 2 years
- ✕Prior bone-seeking beta-emitting radioisotopes or PSMA-targeted radionuclide therapy (prior radium-223 allowed if >12 weeks prior)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating 225Ac-J591, Pembrolizumab, and 2 other interventions for Prostate Cancer. Currently recruiting, targeting 52 participants across 4 sites.
Detailed Summary
This is a phase I/II study investigating the combination of 225Ac-J591 (a drug that can deliver radiation to prostate cancer cells) with pembrolizumab (immunotherapy, a drug that increases the immune system's ability to destroy cancer cells). This study will assess whether 225Ac-J591 + pembrolizumab + androgen receptor inhibitor (ARI) is more effective against prostate cancer than pembrolizumab + ARI alone.
Study Details
Timeline
Interventions
Alpha-emitter Actinium-225 conjugated to the anti-PSMA antibody J591.
Pembrolizumab will be administered intravenously, 400mg every 6 weeks. Patients may receive maximum 18 cycles of therapy, approximately 2 years.
Patients will receive an oral androgen receptor inhibitor (ARI). Examples include enzalutamide, apalutamide, darolutamide. Dosing will be the standard dosing, as described by the package insert.
\[185 ±74 MBq or 5 ±2 mCi\] intravenous during screening and 12 weeks. Imaging agent for PSMA PET/CT.