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

Recruiting now · Phase 2

Conditions studied: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

In brief

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

Key facts

Study ID

NCT06134232

Run by

Dendreon

People needed

400

Starts

2023-10-02

Expected to finish

2032-06-30

Last updated by the study team

2025-08-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:
• 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).
• Have qualified for on-label PROVENGE® infusion
• Have received all 3 infusions of PROVENGE® prior to randomization
• Written informed consent provided prior to the initiation of study procedures
• Estimated life expectancy ≥12 months

You may not qualify if…

• A subject will not be eligible for participation in this study if any of the following criteria apply.
• Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).
• 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)
• 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.
• On experimental or investigational therapy.

Where it is running

• Spokane Urology — Spokane, Washington, United States (enrolling)
• City of Hope - National Medical Center — Duarte, California, United States (enrolling)
• Urology Associates of Central California Medical Group — Fresno, California, United States (enrolling)
• Unio Health Partners - Genesis Research, LLC — San Diego, California, United States (enrolling)
• Colorado Urology — Lakewood, Colorado, United States (enrolling)
• Advanced Urology Institute — Daytona Beach, Florida, United States (enrolling)
• Advanced Urology Institute — Largo, Florida, United States (enrolling)
• Advanced Urology Institute — Ocala, Florida, United States (enrolling)
• Florida Urology Partners — Riverview, Florida, United States (enrolling)
• Arizona Urology Specialists — Tuscon, Arizona, United States (enrolling)
• UroPartners — Glenview, Illinois, United States (enrolling)
• Advanced Urology Associates — New Lenox, Illinois, United States (enrolling)
• Urology of Indiana — Carmel, Indiana, United States (enrolling)
• First Urology — Jeffersonville, Indiana, United States (enrolling)
• Urologic Specialists of Northwest Indiana — Merrillville, Indiana, United States (enrolling)
• Chesapeake Urology Research Associates — Towson, Maryland, United States (enrolling)
• Michigan Institute of Urology — Troy, Michigan, United States (enrolling)
• Specialty Clinical Research of St. Louis — St Louis, Missouri, United States (enrolling)
• Integrated Medical Professionals — North Hills, New York, United States (enrolling)
• Associated Medical Professionals of NY — Syracuse, New York, United States (enrolling)
• Associated Urologists of North Carolina — Raleigh, North Carolina, United States (enrolling)
• The Urology Group — Cincinnati, Ohio, United States (enrolling)
• Central Ohio Urology Group — Gahanna, Ohio, United States (enrolling)
• Oregon Urology Institute — Springfield, Oregon, United States (enrolling)
• MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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