RECRUITINGPhase 2INTERVENTIONAL
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
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
About This Trial
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form provided prior to the initiation of study procedures
5. Estimated life expectancy ≥12 months
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Sipuleucel-T Injection
Single Infusion
Locations (20)
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