NCT06134232

Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Dendreon · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).

Detailed description

Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.

Conditions

• Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
DRUG	Sipuleucel-T Injection	Single Infusion

Timeline

• Start date: 2023-10-02
• Primary completion: 2031-12-31
• Completion: 2032-06-30
• First posted: 2023-11-18
• Last updated: 2025-08-27

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study