Study on Enzalutamide and Indomethacin for Treating Recurrent or Metastatic Hormone-Resistant Prostate Cancer

Sponsor: Mamta Parikh

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02935205

Provider View

This clinical trial is exploring the effects of combining enzalutamide and indomethacin to treat prostate cancer that has returned, spread, or does not respond to hormone treatments. The study aims to see if this combination can reduce cancer growth by lowering or blocking hormones that fuel cancer cells.

Patient Parameters

Program Overview

This study is testing a combination of two drugs, enzalutamide and indomethacin, to see if they can help treat prostate cancer that has come back, spread, or is resistant to hormone therapy. These drugs may work by reducing the levels of androgens (hormones that can promote cancer growth) or by blocking their effects on cancer cells. The trial will assess the safety of this treatment and its ability to lower prostate-specific antigen (PSA) levels, which indicate cancer activity.

Description

The main goal of this study is to determine if the combination of enzalutamide and indomethacin is safe and can reduce PSA levels by 50% or more in patients with hormone-resistant prostate cancer. Secondary goals include evaluating the overall response to treatment, progression-free survival, and overall survival of patients. Researchers will also analyze tumor and blood samples to understand how patients respond to the treatment.

Participants will take enzalutamide once daily and indomethacin once or twice daily. Treatment cycles repeat every four weeks unless the cancer progresses or side effects become unacceptable. After completing the study treatment, patients will be monitored for three months.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed prostate cancer that has returned after treatment or has spread.
  • Cancer must be resistant to hormone therapy, shown by disease progression or rising PSA levels.
  • Measurable disease is not required, but if present, must be assessed by scans or exams.
  • Must have been medically or surgically castrated, with testosterone levels below 50 ng/dL.
  • Must be in good general health with a performance status of 0 to 2.
  • Must have a life expectancy of more than six months.
  • Must have adequate blood cell counts and organ function.
  • Must agree to use contraception during the study and for four months after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Recent chemotherapy or radiotherapy within four weeks before the study.
  • Use of other investigational drugs within the last four weeks.
  • Use of alternative medicines for prostate cancer treatment.
  • Previous treatment with enzalutamide or ketoconazole.
  • Other cancers within the last three years, except certain skin cancers.
  • Known brain metastases or severe neurological issues.
  • Allergies to enzalutamide or indomethacin.
  • Uncontrolled illnesses or infections.
  • HIV-positive patients on antiretroviral therapy.
  • Gastrointestinal issues affecting drug absorption.
  • Active bleeding disorders.
  • History of noncompliance with medical treatments.
  • Severe symptoms from metastatic prostate cancer unless managed.
  • History of seizures or certain brain conditions.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.