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

Inclusion 19

• Minimum age: 18 years
• Eligible sex: Male
• Study condition: Prostate Cancer
• 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.