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Study details
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Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC

Yale University
NCT IDNCT06100705ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

26

Study length

about 4.3 years

Ages

18+

Locations

1 site in CT

What this study is about

This trial is testing a treatment called Sipuleucel-T given with bipolar androgen therapy to men with metastatic castration-resistant prostate cancer. The goal is to see how well the Sipuleucel-T vaccine works when combined with bipolar androgen therapy.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Sipuleucel-T
  • 2.Take Testosterone Cypionate

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IVintramuscular

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

sipuleucel-T, Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) (Androgen Receptor Agonists)

Drug routes

injection, intramuscular

Endpoints

Secondary: To assess safety and tolerability to BAT+ Sipuleucel-T, To determine PSA50 response rate to BAT + Sipuleucel-T, To determine ex vivo cytokine profiles with BAT + Sipuleucel-T, To determine objective response rate (ORR) to BAT + Sipuleucel-T, To estimate overall survival (OS), To estimate radiographic progression free survival (rPFS)

Body systems

Oncology