Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
Recruiting · NCT06134232 · Interventional (participants receive a specific treatment) · Lead sponsor: Dendreon
View the official record on ClinicalTrials.gov →Interventions studied
Sipuleucel-T Injection
What this trial is about
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
31 locations listed across 18 US states.
- Arizona Urology Specialists - Tuscon, Arizona, United States
- City of Hope - National Medical Center - Duarte, California, United States
- Urology Associates of Central California Medical Group - Fresno, California, United States
- Unio Health Partners - Genesis Research, LLC - San Diego, California, United States
- Colorado Urology - Lakewood, Colorado, United States
- Advanced Urology Institute - Daytona Beach, Florida, United States
- Advanced Urology Institute - Largo, Florida, United States
- Advanced Urology Institute - Ocala, Florida, United States
- Florida Urology Partners - Riverview, Florida, United States
- Associated Urological Specialists - Chicago Ridge, Illinois, United States
- UroPartners - Glenview, Illinois, United States
- Advanced Urology Associates - New Lenox, Illinois, United States
- Urology of Indiana - Carmel, Indiana, United States
- First Urology - Jeffersonville, Indiana, United States
- Urologic Specialists of Northwest Indiana - Merrillville, Indiana, United States
- Chesapeake Urology Research Associates - Towson, Maryland, United States
- Michigan Institute of Urology - Troy, Michigan, United States
- Specialty Clinical Research of St. Louis - St Louis, Missouri, United States
- Integrated Medical Professionals - North Hills, New York, United States
- Associated Medical Professionals of NY - Syracuse, New York, United States
- Associated Urologists of North Carolina - Raleigh, North Carolina, United States
- The Urology Group - Cincinnati, Ohio, United States
- Central Ohio Urology Group - Gahanna, Ohio, United States
- Oregon Urology Institute - Springfield, Oregon, United States
- MidLantic Urology - Bala-Cynwyd, Pennsylvania, United States
- Keystone Urology Specialists - Lancaster, Pennsylvania, United States
- Lowcountry Urology Institute - Charleston, South Carolina, United States
- Carolina Urologic Research Center, LLC - Myrtle Beach, South Carolina, United States
- Urology Associates of Nashville - Nashville, Tennessee, United States
- Urology of Virginia - Virginia Beach, Virginia, United States
- Spokane Urology - Spokane, Washington, United States