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Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
RecruitingPhase 2
Phase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Who can join
Ages 18 and older · Men
Full eligibility criteria
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 (ECOG) Performance Scale. * Any one of the following three high risk features: * Gleason grade \> 8-10 * PSA \> 20 ng/ml * Clinical stage T3a (resectable) * No evidence of metastases . * No other diagnosis of malignancy (with exception of non-melanoma skin cancer or a malignancy diagnosed ≥5 years ago). * Male subjects of childbearing potential must agree to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through the time of surgery. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. * Demonstrate adequate organ function, all screening labs should be performed within 30 days of treatment initiation.
About the study
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.
What is being tested
- Pembrolizumab (drug)
- Enzalutamide (drug)
Sponsor: Mark Garzotto, MD · Participants: 32 · Started: Dec 3, 2018
Contact the study team
- Wesley Stoller, MA · Phone: 5032208262
- Mark Garzotto, MD · Phone: 5032208262
Official record on ClinicalTrials.gov — NCT03753243
Locations in the U.S.
| Oregon | VA Portland Healthcare System, Portland |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.