This is a non-comparative open-label multicenter Phase 2 clinical trial combining stereotactic body radiation therapy (SBRT) and pembrolizumab with or without intratumoral SD-101 in patients with newly diagnosed hormone-naive oligometastatic prostate cancer.
This randomized phase II trial studies how well androgen deprivation therapy, pembrolizumab, and stereotactic body radiation therapy with or without toll-like receptor 9 (TLR9) agonist SD-101 in treating patients with prostate cancer and cancer in all oligometastatic sites that has spread to other places in the body. Androgen can cause the growth of tumor cells. Androgen deprivation therapy, such as leuprolide acetate, prednisone, and abiraterone acetate may lessen the amount of androgen made by the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Colony-stimulating factors, such as TLR9 agonist SD-101, may increase the production of blood cells. It is not yet known whether giving androgen deprivation therapy, pembrolizumab, and stereotactic body radiation therapy with or without TLR9 agonist SD-101 may work better in treating patients with prostate cancer and cancer in all oligometastatic sites.
PRIMARY OBJECTIVES
--To assess the safety associated with giving RT and pembrolizumab with or without intratumoral SD-101.
SECONDARY OBJECTIVES
EXPLORATORY OBJECTIVE
| Condition | Prostatic Neoplasms |
|---|---|
| Treatment | prednisone, Pembrolizumab, Leuprolide Acetate, stereotactic body radiation therapy, abiraterone acetate, SD-101 |
| Clinical Study Identifier | NCT03007732 |
| Sponsor | Lawrence Fong |
| Last Modified on | 10 October 2022 |
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