Status:
RECRUITING
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
Lead Sponsor:
Dendreon
Collaborating Sponsors:
WCG IRB
Talosix
Conditions:
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Detailed Description
Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2032
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06134232
Start Date
October 2 2023
End Date
June 30 2032
Last Update
August 27 2025
Active Locations (31)
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1
Arizona Urology Specialists
Tuscon, Arizona, United States, 85741
2
City of Hope - National Medical Center
Duarte, California, United States, 91010
3
Urology Associates of Central California Medical Group
Fresno, California, United States, 93720
4
Unio Health Partners - Genesis Research, LLC
San Diego, California, United States, 92123