Portland, Oregon 97239


Purpose:

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.


Study summary:

The investigators propose to study the effects of pembrolizumab combined with intensive androgen receptor (AR) targeting prior to prostatectomy with extended pelvic lymph node dissection in subjects with high-risk localized prostate cancer (HRLPC). Trial Design- single arm, single-stage, open label Phase II of neoadjuvant immune-hormonal therapy in high-risk localized prostate cancer. Objectives To evaluate efficacy and safety of pembrolizumab combined with intensive AR targeting prior to prostatectomy in subjects with high-risk localized prostate cancer (HRLPC). Primary Endpoint Pathologic complete response (pCR) defined as absence of detectable malignant cells in the prostatectomy specimen evaluated by standard histologic techniques.


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.


NCT ID:

NCT03753243


Primary Contact:

Principal Investigator
Mark Garzotto, MD
Portland VA Medical Center

Wesley Stoller, MA
Phone: 5032208262 ext. 54931
Email: stoller@ohsu.edu


Backup Contact:

Email: mark.garzotto@va.gov
Mark Garzotto, MD
Phone: 5032208262 ext. 51982


Location Contact:

Portland, Oregon 97239
United States

Wesley Stoller, MA
Phone: 503-220-8262
Email: stoller@ohsu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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