23
Participants
Start Date
May 17, 2017
Primary Completion Date
March 31, 2025
Study Completion Date
March 31, 2025
Pembrolizumab
200 mg IV every 21 days for up to 13 doses (Arms 1 and 2)
SD-101
5 mg will be delivered to the dominant prostatic tumor lesion at time of fiducial marker placement (1-5 weeks prior to Cycle 1, Day 1) and and 1-3 weeks after Cycle 1 Day 1
Leuprolide acetate
22.5 mg will be given intramuscularly (IM). First injection 3 months prior to Cycle 1 Day 1. Intermittent androgen deprivation therapy will be given every 3 months starting Cycle 1, Day 1 for 3 additional doses.
Abiraterone Acetate
1000 mg oral dosage will be given daily for 3 months prior to Cycle 1, Day 1 and daily for 9 months starting Cycle 1, Day 1.
Prednisone
5 mg oral dosage will be given daily for 3 months prior to Cycle 1 Day 1 and daily for 9 months starting Cycle 1, Day 1.
Stereotactic Body Radiation Therapy
7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
University of California San Francisco, San Francisco
Prostate Cancer Foundation
OTHER
Merck Sharp & Dohme LLC
INDUSTRY
TriSalus Life Sciences, Inc.
INDUSTRY
David Oh
OTHER