Study on Combining EPI-7386 with Enzalutamide and Hormone Therapy for Metastatic Hormone-Sensitive Prostate Cancer

Sponsor: Pedro Barata, MD, MSc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06312670

Provider View

This clinical trial is testing a new treatment that combines EPI-7386 with Enzalutamide and hormone therapy to see if it can better control prostate cancer that has spread and is sensitive to hormones. Participants will take EPI-7386 twice daily and Enzalutamide once daily, with regular clinic visits every two weeks.

Patient Parameters

Program Overview

The study aims to find out if the combination of EPI-7386 and Enzalutamide can effectively treat prostate cancer that has spread and is still sensitive to hormone therapy. Researchers will also study how the body processes EPI-7386 when taken with Enzalutamide. Participants will take EPI-7386 twice a day and Enzalutamide once a day, with clinic visits every two weeks to monitor their health and response to the treatment.

Description

EPI-7386 is an experimental drug that works by blocking the androgen receptor in a different way than current treatments. This may make it more effective when used with approved drugs like Enzalutamide. EPI-7386 is not yet approved by the FDA, so its safety and effectiveness need to be studied. Enzalutamide is already approved for prostate cancer that has spread after other treatments. The study hopes to show that adding EPI-7386 to standard hormone therapy can improve treatment outcomes for prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed prostate cancer without small cell or neuroendocrine features.
  • Must not have received previous second-generation antiandrogen therapies.
  • Can have new or returning metastatic disease, with at least one visible tumor on scans.
  • Must be 18 years or older.
  • Must show evidence of metastatic disease through specific imaging tests.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have normal organ and blood function, including:
    • Neutrophil count over 1000/μL, platelet count over 100,000/μL, hemoglobin over 8.5 g/dL.
    • Total bilirubin under 2 times the normal limit, except for those with Gilbert syndrome.
    • ALT and AST under 5 times the normal limit.
    • Creatinine clearance of at least 45 mL/min.
    • Albumin over 30 g/L.
  • Must be on a stable dose of bone-targeting therapy if applicable.
  • Radiation therapy is allowed as needed.
  • Must agree to use effective birth control during and for 3 months after treatment.
  • Must understand and sign a consent form.
  • At least 20% of participants must be of African American descent.

Exclusion Criteria

  • Evidence of metastatic castration-resistant prostate cancer (mCRPC).
  • Use of other investigational drugs.
  • Diagnosis of another significant cancer within the last 3 years, except for certain skin or bladder cancers.
  • Gastrointestinal issues affecting drug absorption.
  • History of seizures or conditions that increase seizure risk.
  • Known allergies to EPI-7386 or Enzalutamide.
  • Use of certain drugs that affect how the body processes EPI-7386 or Enzalutamide.
  • Uncontrolled illnesses that could interfere with the study, such as infections or heart problems.

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