Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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).
Eligibility criteria
Qualifiers
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 treating investigator.
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 Resonance Image (MRI).
Disqualifiers
PSA >20ng/dL within the 4 weeks prior to signing ICF
Previously treated with three or more FDA-approved androgen/AR signaling inhibitors (ASI) (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). No minimum number of ASI is required.
Prior chemotherapy for mCRPC. However, prior chemotherapy administered for mCSPC is allowed unless the disease progression to CRPC occurred within 12 months from the last dose of chemotherapy.
Prior treatment with Sipuleucel-T or supraphysiologic dose of testosterone treatment for prostate cancer.
Trial design
Treatments tested in this trial
- Testosterone Cypionate
- Sipuleucel-T
Treatment groups
26 Participants
are divided into 1 treatment groupSponsors and collaborators
Yale University
Lead sponsor
Dendreon
Collaborator
Source ClinicalTrials.gov