Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer
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
26 participants
Feb 14, 2023
INTERVENTIONAL
Conditions
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
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
1000 mg of Abiraterone will be given orally daily plus prednisone 5-10 mg daily
160 mg of Enzalutamide will be given orally daily ending at week 4
240 mg of Apalutamide will be given orally daily ending at week 4
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)
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NCT05751941