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Enzalutamide and Indomethacin in Treating Patients With Recurrent or Metastatic Hormone-Resistant Prostate Cancer

Stage IV Prostate Cancer Clinical Trial

Official title:
A Phase I/II Study of Enzalutamide in Combination With Indomethacin in Castration-Resistant Prostate Cancer (CRPC)

Clinical Trial Summary

This phase I/II trial studies the side effects of enzalutamide and indomethacin and to see how well they work in treating patients with prostate cancer that does not respond to treatment with hormones, has come back, or has spread from where it started to other places in the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To assess the toxicity of indomethacin and enzalutamide when given in combination, and to determine the prostate-specific antigen (PSA) response that is defined as 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 castration-resistant prostate cancer (CRPC) patients treated with indomethacin and enzalutamide. III. To evaluate molecular correlatives for patient response and outcomes through the analysis of patient baseline tumor specimens (diagnostic biopsy) along with serial blood specimens. OUTLINE: Patients receive enzalutamide orally (PO) once daily (QD) and indomethacin PO twice daily (BID) or QD. 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02935205
Study type Interventional
Source University of California, Davis
Contact
Status Recruiting
Phase Phase 1/Phase 2
Start date January 17, 2017
Completion date December 2024
View Details
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