Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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).
Sponsor: Yale University
You may qualify if…
- ✓ 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).
- ✓ Progressive castration-resistant prostate cancer (CRCP): Participants must have current or historical evidence of disease progression concomitant with surgical or medical castration and during immediate past systemic therapy, as demonstrated by (a) PSA progression, or (b) progression of measurable disease, or (c) progression of non-measurable disease as defined below:
- ✓ 1. By PSA: two consecutively rising PSA values, at least 7 days apart, each ≥ 1.0 ng/mL and ≥ 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.
- ✓ 2. By measurable disease: Progressive disease by RECIST v1.1 criteria
- ✓ 3. By non-measurable disease
You may not qualify if…
- ✕ 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.
- ✕ Prior systemic treatment with ASI, PARP inhibitor or Radium-223 or other systemic anti-cancer therapy for prostate cancer within 4 weeks prior to start of treatment.
- ✕ Prior prednisone \>10mg (or its equivalent) within 2 weeks prior to registration.
- ✕ Prior immunotherapy or Lu177 PSMA radioligand therapy within 6 weeks prior to registration.
- ✕ Prior palliative radiotherapy within 2 weeks prior to registration.
Where it's recruiting
New Haven
Source: ClinicalTrials.gov · NCT06100705 · last updated 2025-11-04