NCT05751941

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone	1000 mg of Abiraterone will be given orally daily plus prednisone 5-10 mg daily
DRUG	Enzalutamide	160 mg of Enzalutamide will be given orally daily ending at week 4
DRUG	Apalutamide	240 mg of Apalutamide will be given orally daily ending at week 4
DRUG	Sipuleucel-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.

Timeline

• Start date: 2023-02-14
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2023-03-02
• Last updated: 2026-03-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study