This study will enroll prostate cancer patients with an unfavorable intermediate- or high-risk diagnosis. The purpose of this study is to determine whether a regimen of pembrolizumab and low dose prostate radiation or low dose prostate radiation alone prior to a prostatectomy affects cells of the immune system and if it is a safe option for this stage of prostate cancer. Participants will be randomized 1:1 (like flipping a coin) to receive pembrolizumab, low dose prostate radiation and a prostatectomy or low dose prostate radiation and a prostatectomy. Pembrolizumab is an investigational drug that increases the ability of the immune system to kill tumor cells. Low dose radiation can alter the way tumor cells look to the immune cells. For example, the immune cells may express different proteins that make them more susceptible to immune cell killing or the structure of the tumor may be altered to allow the immune cells to infiltrate the tumor more thoroughly. The prostate tissue collected from the prostatectomy will be analyzed for differences in pathology and local immune cell infiltration, and participants will be followed for 2 years to watch for prostate specific antigen (PSA) recurrence and prostate cancer recurrence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
400 mg of pembrolizumab (KEYTRUDA) will be given by IV every 6 weeks for 9 cycles, for approximately one year of study drug administration.
A single dose of 2 Gy of radiation will be given to the prostate and seminal vesicles on approximately Week 7 for Arm A and approximately 2 weeks prior to the prostatectomy for Arm B.
Robotic assisted laparoscopic prostatectomy (RALP) surgery will be performed at approximately Week 9 for Arm A and approximately 2 weeks after the low dose prostate radiation for Arm B. This surgery is part of the participants routine medical care.
Duke University Medical Center
Durham, North Carolina, United States
Total number of CD8+ T-cells in prostatectomy samples
Total number of CD8+ T-cell profiles in prostate tumor samples removed by RALP in men treated with preoperative low dose prostate radiation (LDPR) alone or with preoperative pembrolizumab.
Time frame: Prostatectomy (Week 7 for Arm A, Week 3 for Arm B)
Location of CD8+ T-cells in prostatectomy samples
Description of location of CD8+ T-cell profiles of prostate tumor samples removed by RALP in men treated with preoperative low dose prostate radiation (LDPR) alone or with preoperative pembrolizumab.
Time frame: Prostatectomy (Week 7 for Arm A, Week 3 for Arm B)
Characteristics of CD8+ T-cells in prostatectomy samples
Description of Characteristics of CD8+ T-cell profiles of prostate tumor samples removed by RALP in men treated with preoperative low dose prostate radiation (LDPR) alone or with preoperative pembrolizumab.
Time frame: Prostatectomy (Week 7 for Arm A, Week 3 for Arm B)
Acute safety profile
Description of the acute (30 day) safety profile of participants receiving low dose prostate radiation pre-operatively with or without pembrolizumab
Time frame: 30 days after prostatectomy
Long term safety profile
Description of the long term (2 year) safety profile of participants receiving low dose prostate radiation pre-operatively with or without pembrolizumab
Time frame: 2 years after prostatectomy
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