Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostat
This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the
| Condition(s) | Prostate Cancer, Metastatic Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T. |
| Who can participate | Inclusion Criteria: * Asymptomatic or minimally symptomatic metastatic prostate cancer, and the diagnosis of prostate cancer needs to be histologically confirmed by biopsy of the prostate or a metastatic lesion * On combined ADT with LHRH analog and a NHA (enzalutamide, apalutamide or abiraterone) for metastatic prostate cancer with PSA progression, but no imaging progression based on the prostate cancer working group (PCWG) 3 criteria * Age 18 or above * ECOG performance status 0 or 1 * Participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count ≥1,000/mcL * Platelets ≥100,000/mcL * Hemoglobin \> 10 g/dl * AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN * Creatinine 1.5 ≤ institutional ULN * Human immunodeficiency virus (HIV)-infected participants on |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Locations | Tampa, Florida, United States; Columbus, Ohio, United States |
| Start date | 2023-02-14 |
| NCT ID | NCT05751941 |
| Official listing | https://clinicaltrials.gov/study/NCT05751941 |