Study on Abiraterone Acetate, Prednisone, and Apalutamide for Treating Patients with Untreated Metastatic Prostate Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03821792

Provider View

This clinical trial is exploring how well a combination of medications—abiraterone acetate, prednisone, and apalutamide—works in treating prostate cancer that has spread and has not been treated with hormone therapy before. These medications may help reduce the levels of hormones that promote cancer growth.

Patient Parameters

Program Overview

The purpose of this study is to see if a combination of medications—abiraterone acetate, prednisone, and apalutamide—can effectively treat prostate cancer that has spread to other parts of the body and has not been treated with hormone therapy before. These medications work by reducing the amount of hormones that can cause prostate cancer cells to grow.

Description

The study aims to find out if a specific pattern in the cancer cells can predict how well the treatment will work. It will also look at how effective and safe the combination of abiraterone acetate and apalutamide is for patients with untreated metastatic prostate cancer.

Participants will take abiraterone acetate and apalutamide by mouth daily, along with prednisone twice a day. The treatment cycles repeat every 28 days for up to a year, as long as the cancer does not progress or cause unacceptable side effects. After finishing the treatment, patients will have follow-up visits 30 days later and then for up to 6 months.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of prostate cancer.
  • Must have at least two of the following high-risk factors:
    • Gleason score of 8 or higher.
    • Three or more bone lesions.
    • Measurable cancer spread to organs other than lymph nodes.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate blood counts and organ function as determined by specific tests.
  • Able to swallow pills.
  • Agree to use effective birth control methods during the study and for 3 months after the last dose.
  • Willing to provide tissue samples for research purposes.

Exclusion Criteria

  • Have small cell prostate cancer.
  • Have received certain treatments for metastatic prostate cancer within 28 days before starting the study, with some exceptions.
  • Have a chronic condition requiring high doses of corticosteroids.
  • Have an active infection or medical condition that makes steroid use unsafe.
  • Have another cancer that required treatment in the past 5 years, except for certain skin cancers.
  • Have uncontrolled high blood pressure.
  • Have a prolonged QT interval on an ECG.
  • Have active liver disease or significant heart disease.
  • Have a history of conditions that increase the risk of bowel perforation.
  • Have moderate to severe liver impairment.
  • Have a history of seizures or conditions that may lead to seizures.
  • Have a gastrointestinal disorder affecting absorption.
  • Have untreated spinal cord compression.
  • Have any medical or psychiatric condition that makes the study treatment unsafe.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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