Study on PROVENGE® and Sipuleucel-T for Men with Advanced Prostate Cancer
Sponsor: Dendreon
ClinicalTrials ID:NCT06134232
This clinical trial is exploring how an additional dose of Sipuleucel-T, after initial treatment with PROVENGE®, affects the immune response in men with advanced prostate cancer that no longer responds to hormone therapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to understand the changes in immune response when men with metastatic castrate-resistant prostate cancer (mCRPC) receive a booster dose of Sipuleucel-T after completing their initial PROVENGE® treatment. This research is conducted across multiple centers and involves patients who have already undergone the standard PROVENGE® therapy.
Description
Participants in this study will have already completed their treatment with PROVENGE®, an immunotherapy for prostate cancer. They will then be randomly selected to receive an additional booster dose of Sipuleucel-T. The goal is to see how this extra dose affects their immune system's ability to fight cancer.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 years or older who need treatment with PROVENGE® for advanced prostate cancer that no longer responds to hormone therapy.
- Must have qualified for and received all three infusions of PROVENGE® before joining this study.
- Must provide written consent to participate in the study.
- Must have an estimated life expectancy of at least 12 months.
Exclusion Criteria
- Men who do not need treatment with PROVENGE® for their prostate cancer.
- Those who require ongoing treatment with medications that suppress the immune system, such as certain steroids or experimental therapies.
- Those with uncontrolled illnesses, active infections, or psychiatric conditions that would prevent them from completing the study.
- Those currently participating in other experimental or investigational therapies.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Arizona Urology Specialists | 85741 | Tuscon | Arizona |
| City of Hope - National Medical Center | 91010 | Duarte | California |
| Urology Associates of Central California Medical Group | 93720 | Fresno | California |
| Unio Health Partners - Genesis Research, LLC | 92123 | San Diego | California |
| Colorado Urology | 80228 | Lakewood | Colorado |
| Advanced Urology Institute | 32114 | Daytona Beach | Florida |
| Advanced Urology Institute | 33771 | Largo | Florida |
| Advanced Urology Institute | 34471 | Ocala | Florida |
| Florida Urology Partners | 33578 | Riverview | Florida |
| Associated Urological Specialists | 60415 | Chicago Ridge | Illinois |
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