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NCT06100705 · ClinicalTrials.gov registry record · Phase 2
Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
A Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT06100705: Recruiting Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Yale University.
NCT06100705 is a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Yale University. The registered enrollment target is 26 participants, below the 198-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06100705, a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).
Primary Outcome
As measured by ELISPOT from blood samples in pg/ml
Conditions Studied
Interventions
- DRUG Testosterone Cypionate
- DRUG Sipuleucel-T
Study Locations (1)
Connecticut
- Yale Cancer Center - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2028-03 |
| Phase | Phase 2 |
What NCT06100705 shows while recruiting
NCT06100705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 198-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Testosterone Cypionate is the first listed.
NCT06100705 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06100705 about?
NCT06100705 is a clinical study titled "Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC". This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and g...
What is the current status of trial NCT06100705?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2023-12-20. Estimated completion is 2028-03.
What conditions does trial NCT06100705 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT06100705?
The interventions under investigation include: Testosterone Cypionate (DRUG), Sipuleucel-T (DRUG).
Who is sponsoring clinical trial NCT06100705?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06100705 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Castration-Resistant Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06100705's enrollment target sits among peer trials
26 64th of 69 higher than 5 of 69 other Metastatic Castration-Resistant Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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