PROVENGE® followed by one sipuleucel‑T booster for metastatic castration‑resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open‑label Phase 2 study enrolling men with metastatic castration‑resistant prostate cancer who have completed the three‑dose PROVENGE® regimen. Enrolled participants are randomized, and those assigned to the booster arm receive a single infusion of sipuleucel‑T. Investigators will measure immune response markers and monitor safety and clinical labs over time. The study collects blood samples for immune assays and tracks adverse events and clinical outcomes at participating sites in Arizona and California.

Why it matters

Who can join: the full rules

Inclusion Criteria:

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:

1. Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
2. Have qualified for on-label PROVENGE® infusion
3. Have received all 3 infusions of PROVENGE® prior to randomization
4. Written informed consent provided prior to the initiation of study procedures
5. Estimated life expectancy ≥12 months

Exclusion Criteria:

A subject will not be eligible for participation in this study if any of the following criteria apply.

1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
2. Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1)
3. Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.
4. On experimental or investigational therapy.

Where it's running

• Arizona Urology Specialists
  Tuscon, Arizona, United States Recruiting
• City of Hope - National Medical Center
  Duarte, California, United States Recruiting
• Urology Associates of Central California Medical Group
  Fresno, California, United States Recruiting
• Unio Health Partners - Genesis Research, LLC
  San Diego, California, United States Recruiting
• Colorado Urology
  Lakewood, Colorado, United States Recruiting
• Advanced Urology Institute
  Daytona Beach, Florida, United States Recruiting

Study contacts

• Study coordinator: Margaret Warner-Lubin
• Email: ProvONE@dendreon.com
• Phone: 2064588358

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GI-102 with Pasritamig for metastatic prostate cancer

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• Exploring Terbium-161 PSMA Therapy for Advanced Prostate Cancer

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• REGN15505 Alone or With Cemiplimab or REGN4336 in Advanced Prostate Cancer and Kidney Cancer

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  Recruiting at 6 sites Phase 1/2 Regeneron Pharmaceuticals · Goodyear, Arizona and 5 other locations · NCT07594106

• Oral INR731 alone or with androgen receptor blockers for metastatic castration-resistant prostate cancer

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• Cannabidiol for Pain Relief in End-Stage Metastatic Castration-Resistant Prostate Cancer

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  Recruiting Phase 2 Regionshospital Nordjylland · Gistrup · NCT07549256

• Lu‑177 PSMA‑3D1015 injections for men with metastatic castration‑resistant prostate cancer

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  Recruiting Phase 1 Affiliated Hospital of Jiangnan University · Wuxi, Jiangsu · NCT07537010

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.