At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed prostate adenocarcinoma (de novo small cell neuroendocrine excluded, but treatment-emergent allowed)
- ✓Minimum 3 PSMA-avid lesions on baseline 68Ga-PSMA-11 PET with SUVmax >liver
- ✓Progressive metastatic castration-resistant prostate cancer by PCWG3 criteria
- ✓Castrate level serum testosterone (<50 ng/dL); those without prior orchiectomy must remain on LHRH analogue
- ✕Untreated brain metastases; treated metastases allowed if last treatment >28 days prior, no new/progressive lesions on MRI, and clinically stable without steroids for ≥14 days
- ✕Prior PSMA-directed treatment (radiotherapy, immunotherapy, antibody-drug conjugate)
- ✕Prior Lu-PSMA-based radioligand therapy clinical trial enrollment
- ✕Prior radium-223 or other radioisotope for prostate cancer treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenic Priming With PSMA-Targeted Radioligand Therapy in Advanced Prostate Cancer: A Phase 1b Study of 177Lu-PSMA-617 in Combination With Pembrolizumab
In Brief
A Phase 1 clinical trial evaluating Lutetium Lu 177-PSMA-617 and Pembrolizumab for Castration Levels of Testosterone and 6 related conditions. Completed, enrolled 43 participants across 1 site.
Detailed Summary
This phase Ib trial studies the dose and schedule of 177Lu-PSMA-617 and pembrolizumab in treating persons with castration-resistant prostate cancer that has spread to other places in the body. 177Lu-PSMA-617 carries a radioactive component which attached to the prostate specific membrane antigen (PSMA) receptor found on tumor cells. Its radiation component destroys the tumor cell. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving 177Lu-PSMA-617 and pembrolizumab may work better at treating prostate cancer.
Study Details
Timeline
Interventions
Given IV
Given IV