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Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer
NCT05751941 · View on ClinicalTrials.gov ↗
Study Summary
This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.
Conditions Studied
Interventions
- DRUG Apalutamide
- DRUG Enzalutamide
- DRUG Abiraterone
- DRUG Sipuleucel-T
Study Locations (2)
Florida
- Moffitt Cancer Center — Tampa
Ohio
- Ohio State University Comprehensive Cancer Center — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-02-14 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05751941
The ClinicalTrials.gov registry entry for NCT05751941 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 562 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions — of which Apalutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05751941 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05751941 about?
NCT05751941 is a clinical study titled "Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer". This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastas...
What is the current status of trial NCT05751941?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2023-02-14. Estimated completion is 2026-12.
What conditions does trial NCT05751941 study?
This clinical trial studies the following conditions: Prostate Cancer, Metastatic Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05751941?
The interventions under investigation include: Apalutamide (DRUG), Enzalutamide (DRUG), Abiraterone (DRUG), Sipuleucel-T (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05751941?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 562 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05751941 being conducted?
This trial has 2 study locations across Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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