Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Phase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
About This Trial
- This clinical trial is testing whether combining a daily hormone-blocking pill with an immune-boosting drug given through a vein can help treat prostate cancer before surgery.
- It is open to adults with aggressive, high-risk prostate cancer that has not spread to other parts of the body and who are already scheduled to have their prostate removed.
- If you participate, you will receive these drug treatments in the weeks leading up to your planned operation, which involves taking a daily pill and getting an infusion every three weeks.
- Before taking part, you should know that you must be in good overall health, undergo regular clinic visits and blood tests, and agree to use effective birth control during the study.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is testing whether combining a daily hormone-blocking pill with an immune-boosting drug given through a vein can help treat prostate cancer before surgery.
Study Details
- Start Date: December 3, 2018
- Lead Sponsor: Mark Garzotto, MD
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.
Treatments
- Drug: Pembrolizumab
- Drug: Enzalutamide