At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed, non-metastatic adenocarcinoma of the prostate
- ✓Prostatectomy with extended lymph node dissection planned as primary therapy
- ✓High-risk features: Gleason grade >8-10, PSA >20 ng/ml, or Clinical stage T3a (resectable)
- ✓10 year or longer life expectancy
- ✕Prior or concurrent diagnosis of malignancy, except non-melanoma skin cancer or malignancy diagnosed ≥5 years ago
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT03753243Phase 2RecruitingUpdate OverdueUpdated 50mo ago · Completion was 45mo agoPhase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab and Enzalutamide for Prostate Cancer. Currently recruiting, targeting 32 participants across 1 site.
Signals
Detailed Summary
Pembrolizumab will be administered at a dose of 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Enzalutamide will be administered at dose of 160 mg orally every day. All patients will be required to have at least one high-risk criteria.
Study Details
Timeline
Interventions
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Patients will receive daily oral doses of study drug (enzalutamide 160 mg/day), which will be administered as four capsules/day to be taken at or near the same time each day.