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 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).

Trial Details

NCT ID
NCT06100705
Phase
PHASE2
Sponsor
Yale University
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Testosterone Cypionate
  • Sipuleucel-T
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816

Key Eligibility Criteria

  • Written informed consent obtained prior to the initiation of study procedures.
  • Patients who meet the US FDA-approved indication for Sipuleucel-T: for asymptomatic or minimally symptomatic mCRPC at the discretion of the treatin…
  • Histologically confirmed adenocarcinoma of the prostate.
  • Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or Magnetic Resona…

For full eligibility, visit ClinicalTrials.gov.

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