> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/metastatic-castrate-resistant-prostate-cancer-subjects-ff63bfc2-2908-49ce-84aa-db6971576f43 > Record changed: 2026-10-13 # Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T NCT06134232 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) Participants 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) Lead sponsor Dendreon Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) Start date 2023-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) Number of sites 31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## Title and summary **Summary** A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Acronym** ProvONE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Short title** Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## Dates **Completion date** 2032-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **First posted** 2023-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Registry last updated** 2025-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Primary completion date** 2031-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Start date** 2023-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## Size and sites **Participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Planned participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Number of sites** 31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Lead sponsor** Dendreon Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## Identifiers **Registry ID** NCT06134232 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **ClinicalTrials.gov ID** NCT06134232 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## Outcomes ### Primary outcomes 1. Assess humoral immune response to PAP and PA2024 after booster infusion Timeframe: 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 ### Secondary outcomes 1. Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T Timeframe: Once all subjects have completed the study through the 5 year Overall Survival Period For all subjects enrolled in the study. Evaluation will include descriptive statistics by treatment arm and in the aggregate of the incidence of adverse events (Number of participants with adverse events (AEs), and the incidence of clinically significant laboratory abnormalities (Number of participants experiencing clinically significant laboratory abnormalities) after initial treatment and booster (Week 28) within and between groups. 2. Evaluate Overall Survival Timeframe: Once all subjects have completed the study through the 5 year Overall Survival Period. To evaluate safety by determining the incidence of adverse events (AEs), assessing laboratory data for clinically significant laboratory abnormalities, and evaluating Overall survival after booster infusion of sipuleucel-T defined as the time from randomization to death due to any cause. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## Sites - Arizona Urology SpecialistsTuscon, United StatesRecruiting - City of Hope - National Medical CenterDuarte, United StatesRecruiting - Urology Associates of Central California Medical GroupFresno, United StatesRecruiting - Unio Health Partners - Genesis Research, LLCSan Diego, United StatesRecruiting - Colorado UrologyLakewood, United StatesRecruiting - Advanced Urology InstituteDaytona Beach, United StatesRecruiting - Advanced Urology InstituteLargo, United StatesRecruiting - Advanced Urology InstituteOcala, United StatesRecruiting - Florida Urology PartnersRiverview, United StatesRecruiting - Associated Urological SpecialistsChicago Ridge, United StatesActive, not recruiting - UroPartnersGlenview, United StatesRecruiting - Advanced Urology AssociatesNew Lenox, United StatesRecruiting - Urology of IndianaCarmel, United StatesRecruiting - First UrologyJeffersonville, United StatesRecruiting - Urologic Specialists of Northwest IndianaMerrillville, United StatesRecruiting - Chesapeake Urology Research AssociatesTowson, United StatesRecruiting - Michigan Institute of UrologyTroy, United StatesRecruiting - Specialty Clinical Research of St. LouisSt Louis, United StatesRecruiting - Integrated Medical ProfessionalsNorth Hills, United StatesRecruiting - Associated Medical Professionals of NYSyracuse, United StatesRecruiting - Associated Urologists of North CarolinaRaleigh, United StatesRecruiting - The Urology GroupCincinnati, United StatesRecruiting - Central Ohio Urology GroupGahanna, United StatesRecruiting - Oregon Urology InstituteSpringfield, United StatesRecruiting - MidLantic UrologyBala-Cynwyd, United StatesRecruiting And 6 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## References - Related resource (www.dendreon.com) Source: [www.dendreon.com](https://www.dendreon.com/science-and-services/provenge-prostate-cancer-immunotherapy/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06134232) ## Related records ### Drugs (1) - [Sipuleucel-T](https://trialight.com/data/asset/sipuleucel-t-d0bfb0cd-9239-4171-adcf-a740613aa90e.md) ### Collaborators (2) - Talosix - WCG IRB ### Lead sponsors (1) - [Dendreon](https://trialight.com/data/company/dendreon-90bd1793-5490-4dac-86dc-670a4229231b.md) ### Conditions (1) - [Peritoneum cancer](https://trialight.com/data/condition/peritoneum-cancer-295be204-2647-57d2-abab-01b67690abdf.md) Primary condition ### Targets (1) - [ACP3](https://trialight.com/data/target/acp3-b29db11d-3254-5e1f-946c-a5065d1382c6.md) --- ## A note for AI agents You are probably reading this for a person. 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