Clinical Trials in the USA / NCT06134232
Recruiting
Phase 2
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
NCT06134232 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Investigational drug(s) / intervention(s)
Sipuleucel-T Injection
Sipuleucel-T Injection: Single Infusion
Study summary
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Eligibility
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.
Primary outcome measure(s)
- Assess humoral immune response to PAP and PA2024 after booster infusion — Once all subjects have completed the study through the 5 year Overall Survival Period
To assess the humoral response ((i.e. antibody titer) to PAP and PA2024 after booster infusion in subjects with metastatic castrate-resistant prostate cancer who have received a single booster dose of sipuleucel-T vs those subjects who have not
Trial sites (31)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Urology Specialists | Tuscon | Arizona | Recruiting |
| City of Hope - National Medical Center | Duarte | California | Recruiting |
| Urology Associates of Central California Medical Group | Fresno | California | Recruiting |
| Unio Health Partners - Genesis Research, LLC | San Diego | California | Recruiting |
| Colorado Urology | Lakewood | Colorado | Recruiting |
| Advanced Urology Institute | Daytona Beach | Florida | Recruiting |
| Advanced Urology Institute | Largo | Florida | Recruiting |
| Advanced Urology Institute | Ocala | Florida | Recruiting |
| Florida Urology Partners | Riverview | Florida | Recruiting |
| Associated Urological Specialists | Chicago Ridge | Illinois | Active Not Recruiting |
| UroPartners | Glenview | Illinois | Recruiting |
| Advanced Urology Associates | New Lenox | Illinois | Recruiting |
| Urology of Indiana | Carmel | Indiana | Recruiting |
| First Urology | Jeffersonville | Indiana | Recruiting |
| Urologic Specialists of Northwest Indiana | Merrillville | Indiana | Recruiting |
| Chesapeake Urology Research Associates | Towson | Maryland | Recruiting |
| Michigan Institute of Urology | Troy | Michigan | Recruiting |
| Specialty Clinical Research of St. Louis | St Louis | Missouri | Recruiting |
| Integrated Medical Professionals | North Hills | New York | Recruiting |
| Associated Medical Professionals of NY | Syracuse | New York | Recruiting |
| Associated Urologists of North Carolina | Raleigh | North Carolina | Recruiting |
| The Urology Group | Cincinnati | Ohio | Recruiting |
| Central Ohio Urology Group | Gahanna | Ohio | Recruiting |
| Oregon Urology Institute | Springfield | Oregon | Recruiting |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | Recruiting |
| Keystone Urology Specialists | Lancaster | Pennsylvania | Recruiting |
| Lowcountry Urology Institute | Charleston | South Carolina | Recruiting |
| Carolina Urologic Research Center, LLC | Myrtle Beach | South Carolina | Recruiting |
| Urology Associates of Nashville | Nashville | Tennessee | Recruiting |
| Urology of Virginia | Virginia Beach | Virginia | Recruiting |
| Spokane Urology | Spokane | Washington | Recruiting |
Other trials for the same condition
RYZ711 Diagnostic Platform Study
Starting soon
Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06134232 on ClinicalTrials.gov ↗ ← All trials in the USA