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.
PRIMARY OBJECTIVES: I. To determine the prostate-specific antigen (PSA) response that is a 50% or more reduction from the baseline. SECONDARY OBJECTIVES: 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. OUTLINE: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
PSA response rate
Percent of patients achieving greater than or equal to 50% PSA declines following initiation of treatment
Time frame: Up to 2 years
Incidence of dose limiting toxicity defined as any grade III non-hematologic toxicity not reversible to grade II or less within 96 hours, or any grade IV toxicity
Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events 4.0. Adverse events and adverse events of grade 3 or higher will be listed for each patient and summarized by body system in a frequency table.
Time frame: 4 weeks
Overall response as determined by PCWG2 criteria
Time frame: From the time measurement criteria are met for complete response/partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years
Overall survival
Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed.
Time frame: Up to 2 years
PFS
Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed. Will be compared with the historic control of abiraterone alone.
Time frame: Up to 2 years
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