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This phase II trial studies the side effects and how well abiraterone acetate, niclosamide, and prednisone work in treating patients with hormone-resistant prostate cancer. Androgens can cause the growth of prostate cells. Hormone therapy using abiraterone acetate may fight prostate cancer by lowering the amount of androgen the body makes. Niclosamide is a drug that may block another signal that can cause prostate cancer cell growth. Prednisone is a drug that can help lessen inflammation. Giving abiraterone acetate, niclosamide, and prednisone may be a better treatment for patients with hormone-resistant prostate cancer.
I. To determine the prostate-specific antigen (PSA) response that is a 50% or more reduction from the baseline.
I. To determine the overall response as determined by the Prostate Cancer Working Group 2 criteria (PCWG2).
II. To evaluate the progression-free survival (PFS) and overall survival of CRPC patients treated with PDMX1001/niclosamide (niclosamide), abiraterone (abiraterone acetate) and prednisone.
III. To assess the toxicity of PDMX1001/niclosamide, abiraterone and prednisone given in combination.
IV. To evaluate molecular correlatives for patient response and outcomes through the analysis of patient baseline tumor specimens (diagnostic biopsy) along with serial blood specimens.
Patients receive abiraterone acetate orally (PO) once a day (QD), niclosamide PO twice a day (BID) and prednisone PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Metastatic Prostate Carcinoma
Abiraterone Acetate, Niclosamide, Prednisone
University of California Davis Comprehensive Cancer Center
Not yet recruiting
University of California, Davis
Published on BioPortfolio: 2016-06-21T19:08:22-0400
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