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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Patients will receive daily oral doses of study drug (enzalutamide 160 mg/day), which will be administered as four capsules/day to be taken at or near the same time each day.
VA Portland Healthcare System
Portland, Oregon, United States
RECRUITINGPathologic Complete Response
No cancer detected on pathology examination of prostatectomy specimen
Time frame: 4 months
Treatment Related Adverse Events
Grade 3 or higher adverse event (AE) possibly related or related to any of three treatment drugs (pembrolizumab, enzalutamide, Gonadotropin-releasing hormone (GNRH) agonist) per CTCAE v4.03, evaluated up until 30 days after prostatectomy
Time frame: 4 months + 30 days
Immune -related Adverse Events
Grade 2 or higher immune related AE possibly related or related to any of three treatment drugs (pembrolizumab, enzalutamide, GNRH agonist) per CTCAE v4.03, evaluated up until 30 days after prostatectomy
Time frame: 4 months + 30 days
Biochemical Complete Response
Prostate-Specific Antigen (PSA) \< 0.1 ng/mL prior to prostatectomy
Time frame: 4 months
Incidence of Surgical Complications
Clavien-Dindo Classification of Surgical Complications compared to historical department incidence rates.
Time frame: 4 months
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