At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the prostate
- ✓Castration-resistant with progression on/after androgen deprivation, castrate testosterone <50 ng/dL, and PSA or bone progression documented
- ✓Metastatic disease demonstrated by bone scan
- ✓Age ≥18 years
- ✕Small cell carcinoma predominance (other neuroendocrine features acceptable)
- ✕Prior radium-223 treatment
- ✕Prior PD-1, PD-L1, or PD-L2 blocking therapy
- ✕Nodal disease ≥15 mm short axis (unless 1.5-3 cm stable ≤5 mm growth over 6 months without symptoms/obstruction)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Phase II Study Evaluating the Addition of Pembrolizumab (MK-3475) to Radium-223 in Metastatic Castration Resistant Prostate Cancer (mCRPC)
In Brief
A Phase 2 clinical trial evaluating Radium-223 and Pembrolizumab for Prostate Cancer. Completed, enrolled 45 participants across 2 sites.
Detailed Summary
This research study is studying the safety and tolerability of an investigational combination of drugs, radium-223 plus pembrolizumab as a possible treatment for castration-resistant prostate cancer. The interventions involved in this study are: * Radium-223 * Pembrolizumab
Study Details
Timeline
Interventions
Radium-223 is a calcium mimetic that hones in on bone metastases. It binds to new bone stroma and emits alpha particles, which induce double-stranded DNA breaks that result in tumor cell death.
Pembrolizumab is a PD-1 inhibitor. Pembrolizumab binds to human PD-1 and blocks the interaction between PD1 and its ligands.