A Phase II Randomized Study of Sipuleucel-T With or Without Continuing New Hormonal Agents (NHA) in Metastatic Prostate Cancer With PSA Progression While on NHA and LHRH Analog
H. Lee Moffitt Cancer Center and Research Institute
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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…
Interventions
- DrugAbiraterone
1000 mg of Abiraterone will be given orally daily plus prednisone 5-10 mg daily
- DrugEnzalutamide
160 mg of Enzalutamide will be given orally daily ending at week 4
- DrugApalutamide
240 mg of Apalutamide will be given orally daily ending at week 4
- DrugSipuleucel-T
Sipuleucel-T is considered standard of care and will be infused into the participant three times at approximately 2-week intervals starting week 0, 2 and 4.
Locations (2)
- Moffitt Cancer CenterTampa, Florida
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio