Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mark Garzotto, MD
• Collaborators: Astellas Pharma Inc; Merck Sharp & Dohme Corp.
• Treatments: Androgens; Pembrolizumab

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.