Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

NCT06134232
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
clinicaltrials.gov
Participants
400
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Lead sponsor
Dendreon
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Start date
2023-10-02
clinicaltrials.gov
Number of sites
31
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Summary
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
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Acronym
ProvONE
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Short title
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2032-06-30
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First posted
2023-11-18
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Registry last updated
2025-08-27
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Primary completion date
2031-12-31
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Start date
2023-10-02
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Participants
400
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Participant count basis
Estimated
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Planned participants
400
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Protocol amendments
1
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Number of sites
31
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Dendreon
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06134232
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ClinicalTrials.gov ID
NCT06134232
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
Male
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (2)

Lead sponsors (1)

Conditions (1)

Targets (1)