Phase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Mark Garzotto, MD
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.
Description
The investigators propose to study the effects of pembrolizumab combined with intensive androgen receptor (AR) targeting prior to prostatectomy with extended pelvic lymph node dissection in subjects with high-risk localized prostate cancer (HRLPC). Trial Design- single arm, single-stage, open label Phase II of neoadjuvant immune-hormonal therapy in high-risk localized prostate cancer. Objectives To evaluate efficacy and safety of pembrolizumab combined with intensive AR targeting prior to prostatectomy in subjects with high-risk localized prostate cancer (HRLPC). Primary Endpoint Pathologic…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Be willing and able to provide written informed consent/assent for the trial. * Capability to understand and comply with the protocol and signed informed consent document. * Be ≥ 18 years of age on day of signing informed consent. * Have measurable disease based on RECIST 1.1. * Histologically confirmed, non-metastatic adenocarcinoma of the prostate * Prostatectomy with extended lymph node dissection planned as primary therapy * 10 year or longer life expectancy based on other co-morbidities * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group…
Interventions
- DrugPembrolizumab
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
- DrugEnzalutamide
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.
Location
- VA Portland Healthcare SystemPortland, Oregon