a study on Prostate Cancer
This is a non-comparative open-label multicenter Phase 2 clinical trial combining definitive prostatic radiotherapy (RT) and pembrolizumab with or without intratumoral SD-101 in patients with newly diagnosed hormone-naive oligometastatic prostate cancer.
Phase 2 Trial Pembrolizumab or Pembrolizumab in Combination With Intratumoral SD-101 Therapy in Patients With Hormone-Naïve Oligometastatic Prostate Cancer Receiving Definitive Prostatic Radiation and Intermittent Androgen Deprivation Therapy
A safety lead-in for each treatment arm will be performed prior to full 1:1 randomization into each arm. Definitive RT to the whole prostate gland will be delivered via high-dose rate (HDR) brachytherapy on Day 1 and Day 8 (+7 days) of Cycle 1 pembrolizumab in each arm. Immediately before RT, SD-101 will be delivered to the dominant prostatic lesion on Day 1 and Day 8 (+7 days) of Cycle 1 pembrolizumab in Arm 2. SD-101 will be administered intratumorally in concert with placement of the HDR brachytherapy catheters. Pembrolizumab will be continued for a total of 13 cycles, until disease progression, or unacceptable toxicity, whichever occurs first. Patients will receive 3 months of androgen deprivation therapy (ADT) run-in, followed by combined androgen blockade (CAB) for 9 months, then discontinuation of ADT. Primary outcome is to evaluate the rate of prostate specific antigen (PSA) < nadir +2 ng/mL at 15 and 24 month from the start of treatment among patients with non-castrate levels of testosterone (>150 ng/dL). Serum, archival prostate biopsy, mandatory baseline metastatic tumor biopsy, and optional repeat biopsy at time of progression, will be obtained to characterize circulating and intratumoral immune responses.
Prostatic Neoplasms Pembrolizumab Methyltestosterone Androgens Ascorbic Acid Estrogens, Conjugated (USP)
Open to people ages 18 years and up
Oligometastatic disease. In order to be eligible, the patient must have a total of <4 metastatic bone and/or metastatic lymph node sites based on bone and/or soft tissue lesions as defined by any of the following:
Adequate Organ Function Laboratory Values:
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