NCT02935205

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Mamta Parikh · Academic / Other
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Prostate Carcinoma
• Recurrent Prostate Carcinoma
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	Given PO
DRUG	Indomethacin	Given PO

Timeline

• Start date: 2017-01-17
• Primary completion: 2024-03-01
• Completion: 2024-12-01
• First posted: 2016-10-17
• Last updated: 2023-11-29

Locations

1 site across 1 country: United States