Actively Recruiting
Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
Led by Yale University · Updated on 2025-11-04
26
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
D
Dendreon
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before starting study procedures
- Have asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer eligible for Sipuleucel-T
- Histologically confirmed prostate adenocarcinoma
- Evidence of metastatic disease on bone scan or CT/MRI
- Show disease progression during castration therapy by rising PSA, measurable disease, or new lesions
- Confirm castration status with serum testosterone level below 50 ng/dL
- Have ECOG performance status of 0 or 1
- Have adequate liver function: Bilirubin below 2.0 x institutional upper limit, AST and ALT below 2.5 x upper limit
- Have acceptable kidney function: Serum creatinine below 2.0 x upper limit
- Have acceptable blood counts: Neutrophils above 1.0 x 10^9/L, Platelets above 100 x 10^9/L, Hemoglobin above 9 g/dL
You will not qualify if you...
- PSA level above 20 ng/dL within 4 weeks before consent
- Treated with three or more androgen receptor signaling inhibitors
- Prior chemotherapy for metastatic castration-resistant prostate cancer
- Previous treatment with Sipuleucel-T or supraphysiologic testosterone doses
- Recent systemic cancer treatments within 4 weeks before start
- Prednisone use above 10 mg daily within 2 weeks before registration
- Recent immunotherapy or Lu177 PSMA therapy within 6 weeks before registration
- Recent palliative radiotherapy within 2 weeks before registration
- Presence of liver metastases on imaging
- Use of narcotics stronger than tramadol for cancer pain within 4 weeks before consent
- Active autoimmune disease requiring high-dose corticosteroids
- Known active infections like HIV, Hepatitis B or C, or HTLV-1
- Active infection requiring IV antibiotics or fever above 100.5°F within 1 week before registration
- Life expectancy under 6 months
- Any condition that could affect study adherence or outcomes as judged by the investigator
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Trial Site Locations
Total: 1 location
1
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
L
Laura Kane
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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