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

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

Phase 2 Interventional Dendreon · NCT06134232

This trial tests whether giving one booster infusion of sipuleucel‑T to men with metastatic castration‑resistant prostate cancer who already completed PROVENGE® can boost their immune response and remain safe.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexMale
SponsorDendreon Industry-sponsored
Drugs / interventionsimmunotherapy
Locations31 sites (Tuscon, Arizona and 30 other locations)
Trial IDNCT06134232 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Men aged 18 or older with asymptomatic or minimally symptomatic metastatic castration‑resistant prostate cancer who have completed all three PROVENGE® infusions, given informed consent and with an estimated life expectancy of at least 12 months are eligible.

Not a fit: Patients who are not clinically indicated for PROVENGE® or who require chronic systemic immunosuppressive therapy are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, a single sipuleucel‑T booster could increase anti‑tumor immune activity and potentially extend clinical benefit after the standard PROVENGE® course.

How similar studies have performed: Sipuleucel‑T has shown a survival benefit in prior clinical trials as an approved therapy, but the effect of a single booster infusion after the standard course is less well studied.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Tuscon, Arizona and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Castration-Resistant Prostate CancerSingle DoseSipuleucel-TImmune Response RateSafetyAdenocarcinoma of the Prostate
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.