Study on Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60

ClinicalTrials ID:NCT03246347

Provider View

This clinical trial is testing a combination of treatments for men with metastatic prostate cancer to see if adding enzalutamide to standard therapies improves outcomes and is well tolerated.

Patient Parameters

Program Overview

This study is exploring whether adding the drug enzalutamide to standard treatments of androgen deprivation therapy (ADT) and docetaxel can improve treatment results for men with metastatic prostate cancer. The trial aims to see if this combination is more effective and safe compared to just using ADT and docetaxel.

Description

This trial is being conducted at the Levine Cancer Institute network across North and South Carolina. It is a Phase II study focusing on men with metastatic hormone-sensitive prostate cancer. The main goal is to evaluate how well the combination of ADT, docetaxel, and enzalutamide works by measuring the prostate-specific antigen (PSA) response after 12 months. The study will compare these results to historical data from patients who received only ADT and docetaxel. Enrollment is expected to be completed within two years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer that has spread to other parts of the body, confirmed by lab tests.
  • Must have metastatic disease, including spread to soft tissue, bones, or non-regional lymph nodes.
  • Started ADT treatment within the last 16 weeks, with specific conditions on PSA levels.
  • Previous ADT for non-metastatic disease is allowed under certain conditions.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate liver, bone marrow, and kidney function as determined by specific blood tests.
  • Able to understand and sign a consent form.
  • Able to swallow oral medication.

Exclusion Criteria

  • History of seizures or conditions that increase seizure risk.
  • Cancer spread to the brain or central nervous system.
  • Conditions affecting absorption of enzalutamide.
  • Previous treatment with certain prostate cancer drugs or chemotherapy.
  • Recent major surgery or radiation therapy.
  • Allergies to specific drug ingredients.
  • Certain neurological conditions or infections like HIV or hepatitis.
  • Uncontrolled illnesses or recent severe heart conditions.
  • Recent history of another active cancer, except for certain skin cancers.
  • Use of specific medications that interact with the study drugs.
  • Need for high doses of steroids for more than 14 days.

Locations

FACILITYZIPCITYSTATE
Levine Cancer Institute28204CharlotteNorth Carolina

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