Study on Androgen Ablation with or without Abiraterone Acetate and Prednisone for Recurrent Prostate Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT01786265

Provider View

This clinical trial is exploring whether a combination of hormone therapy with or without the drugs abiraterone acetate and prednisone can better treat prostate cancer that has returned after initial treatment.

Patient Parameters

Program Overview

This study is investigating how well hormone therapy, which reduces male hormones that can fuel prostate cancer growth, works with or without additional medications, abiraterone acetate and prednisone, in treating prostate cancer that has come back. The trial aims to see if this combination can improve survival without prostate-specific antigen (PSA) levels rising, which indicates cancer activity.

Description

The main goal of this study is to see if an 8-month hormone therapy can improve survival without an increase in PSA levels by 20% compared to hormone therapy alone. Researchers will also look at how quickly testosterone levels recover after treatment and how long patients remain free of PSA increases after testosterone recovery. The study will also explore the presence of minimal residual cancer and use new technologies to detect cancer cells at different stages of the study.

Participants will be randomly assigned to one of two groups:

  • Group A: Patients receive hormone therapy through injections and oral medications for 8 months. If the cancer progresses, they may switch to Group B.
  • Group B: Patients receive the same hormone therapy as Group A, plus abiraterone acetate and prednisone daily for 8 months. If the cancer progresses, they may switch to Group A.

After completing the treatment, patients will have follow-up visits every 3 to 6 months.

Eligibility Criteria

Inclusion Criteria

  • Must understand and agree to participate in the study.
  • Must have a life expectancy of at least 12 months.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have a confirmed diagnosis of prostate cancer that has returned after surgery or radiation, shown by rising PSA levels without evidence of cancer spread.
  • Must have adequate blood cell counts and organ function as determined by specific blood tests.
  • Must have recovered from any previous treatments like surgery or radiation.
  • Must agree to use effective contraception during the study and for one week after the last dose of abiraterone acetate.
  • Must be able to swallow tablets and take abiraterone acetate on an empty stomach.

Exclusion Criteria

  • Cannot have received prior hormonal therapy, except for specific short-term cases.
  • Cannot have known cancer spread.
  • Cannot have significant heart disease or prolonged QT interval on an ECG.
  • Cannot have significant health issues that could affect safety or study results.
  • Cannot have had certain prior cancer treatments or investigational drugs recently.
  • Cannot have active infections or conditions that make prednisone use unsafe.
  • Cannot have allergies to study medications or conditions affecting drug absorption.
  • Cannot require long-term corticosteroid use beyond the study dose.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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