Evaluation of novel treatments in biochemically recurrent prostate

Division Of Basic Sciences - Nci

Investigators

Linked publications & trials

Abstract

Two protocols have been completed. 13-c-0153: Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer has completed the data analysis phase and is pending publication. Enzalutamide alone extends PSA suppression in patients with non-metastatic castration resistant prostate cancer and future studies are planned ti further evaluate this. Furthermore, immune changes were noted after enzalutamide therapy as well. 16-c-0035: Prostvac in Patients With Biochemically Recurrent Prostate Cancer: This study has completed accrual at the NCI, Dana Farber and Sloan Kettering and is now being prepared for publications. Of note, late PSA declines were seen in 15-20% of patients. 18-c-0005: Phase II Trial of Combination Immunotherapy in Biochemically Recurrent Prostate Cancer: This study has completed the safety phase of the trial and now is in the main cohort of non-metastatic castration resistant prostate cancer patients and is accruing at the NCI. We are approximately 2/3 of the way through accrual and expect to compete accrual in the next 6-10 months. 20-c-0010 Radium 233 in biochemically recurrent prostate cancer is evaluating the immune impact of an FDA-approved radiopharmaceutical in patients with micro-metastatic (only PET scan positive) prostate cancer. This study had its accrual held through much of the COVID pandemic but is now approximately 1/3 of the way through accrual with rapid accrual in recent months. Additional studies are being planned with other non-toxic immunotherapy strategies. The uniform use of PET imaging is part of the GMB's programmatic approach to developing clinical trials in BCRpc. All current and future BCRpc studies are evaluating the impact of PSA kinetics on these patients using validated quality of life survey. In addition, the immunologic impact of these treatments on circulating immune cell subsets. And in a collaboration with Dr. Heidi Kong of NIAMS, we are evaluating the microbiome to better understand how baseline the microbiome may be associated with clinical outcomes while also evaluating the influence of experimental therapies on the microbiome in BCRpc.