NCT06134232 · Dendreon
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
(ProvONE)
What this study is about
A conducted at multiple hospitals, where both patients and doctors know the treatment given, forward-looking study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
View original scientific description
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Interventions
DRUG
Sipuleucel-T Injection
Single Infusion
Primary outcome measures
Assess humoral immune response to PAP and PA2024 after booster infusion
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Tuscon, Arizona
- Duarte, California
- Fresno, California
- San Diego, California
- Lakewood, Colorado
- Daytona Beach, Florida
- Largo, Florida
- Ocala, Florida
- Riverview, Florida
- Chicago Ridge, Illinois
- Glenview, Illinois
- New Lenox, Illinois
And 19 more locations — see the full list below.
Collaborators
WCG IRB, Talosix
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2025 · Source of record for eligibility and locations