Study on Apalutamide for Prostate Cancer Patients Before Surgery

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03412396

Provider View

This clinical trial is exploring how well the drug apalutamide works in treating prostate cancer before surgery. The study aims to see if apalutamide can reduce the need for radiation therapy after surgery by lowering androgen levels, which can fuel cancer growth.

Patient Parameters

Program Overview

This study is testing whether taking apalutamide for 6 months before prostate surgery can reduce the risk factors that usually lead to needing radiation therapy afterward. Apalutamide is a hormone therapy that lowers androgen levels, which can help slow down the growth of prostate cancer cells. The trial will also look at the safety of this treatment and how well patients tolerate it. After taking apalutamide, patients will have surgery to remove the prostate and will be monitored for a year to see how they respond.

Description

The main goal of this study is to find out if taking apalutamide for 6 months before prostate surgery can lower the risk of needing radiation therapy afterward from 35% to 15% in patients with intermediate-risk prostate cancer.

Secondary goals include:

  • Checking the safety and side effects of taking apalutamide before surgery.
  • Estimating how often patients have a complete or nearly complete response to the treatment.
  • Studying the molecular features of the treated cancer and linking them to physical characteristics.
  • Measuring the rate of cancer returning within 3-5 years to help plan a larger future study.

Patients will take apalutamide daily for 24 weeks unless the cancer progresses or side effects become unacceptable. After finishing the medication, patients will have surgery to remove the prostate within 2 weeks. They will be followed up 12 months after completing the treatment to monitor their health and any recurrence of cancer.

Eligibility Criteria

Inclusion Criteria

  • Willing to provide written consent to participate.
  • Diagnosed with prostate adenocarcinoma.
  • Had at least 10 core biopsies done, with results available. A recent biopsy within 6 months is acceptable.
  • Meet intermediate risk criteria based on Gleason score, T stage, and PSA levels.
  • Pathology review at MD Anderson Cancer Center confirms enough disease volume for surgery.
  • Serum testosterone level above 200 ng/mL.
  • Suitable for prostate surgery as agreed by patient and urologist.
  • No signs of cancer spread on imaging.
  • ECOG performance status of 0 or 1.
  • Adequate blood counts and organ function as determined by specific tests.
  • Able to swallow the study drug as a tablet.
  • Agree to use effective birth control methods during the study and for 3 months after the last dose.

Exclusion Criteria

  • Prostate cancer with histological variants other than adenocarcinoma.
  • Serious or uncontrolled non-cancerous diseases.
  • PSA level over 20 ng/mL unless considered intermediate risk by the doctor.
  • Uncontrolled high blood pressure.
  • Active liver disease or viral hepatitis.
  • Significant heart disease or recent heart attack.
  • Other active cancers or high risk of recurrence.
  • Gastrointestinal disorders affecting drug absorption.
  • History of pituitary or adrenal disorders.
  • Previous hormone therapy for prostate cancer.
  • Compromised immune system or HIV positive.
  • Not suitable for surgery due to other medical conditions.
  • History of seizures or conditions that increase seizure risk.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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