Phase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer

Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03753243

Sponsor: Mark Garzotto, MD

Phase: Phase 2


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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.

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