Study on Olaparib Plus Abiraterone as First-line Treatment for Men with Advanced Prostate Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT03732820

This clinical trial is testing whether a combination of the drugs olaparib and abiraterone is more effective and safe compared to a placebo with abiraterone in men with advanced prostate cancer that has spread and is resistant to standard hormone therapy.

Patient Parameters

Program Overview

The study aims to find out if combining olaparib with abiraterone can better control advanced prostate cancer that has spread and is resistant to standard hormone therapy. It will compare this combination to a placebo with abiraterone to see which is more effective and safe for patients who have not received chemotherapy or new hormonal treatments for this stage of cancer.

Description

This study, called PROpel, is a phase III trial that looks at how well the combination of olaparib and abiraterone works compared to a placebo with abiraterone in men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The study involves about 796 patients worldwide, with an additional 108 patients from China. Participants will be randomly assigned to receive either olaparib and abiraterone or a placebo and abiraterone. Both groups will also take prednisone or prednisolone. The goal is to see if the combination can improve outcomes for these patients.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent and follow study requirements.
  • Men aged 18 or older (19 in South Korea).
  • Diagnosed with prostate cancer that has spread.
  • Cancer must be resistant to standard hormone therapy.
  • Must be receiving ongoing hormone therapy to lower testosterone levels.
  • Suitable for abiraterone treatment with evidence of cancer progression.
  • Normal organ and bone marrow function.
  • Good overall health with a performance status of 0-1.
  • Life expectancy of at least 6 months.
  • Must provide a tumor sample for analysis.
  • Must use effective contraception during and after treatment.

Exclusion Criteria

  • Have another cancer that has progressed or needed treatment in the last 5 years.
  • Have certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
  • Have significant heart disease or planned heart surgery.
  • Have uncontrolled high blood pressure.
  • Have uncontrolled hormone-related disorders.
  • Have active infections or conditions that prevent steroid use.
  • Have severe side effects from previous cancer treatments.
  • Have brain metastases or spinal cord compression unless stable.
  • Cannot swallow pills or have digestive issues affecting medication absorption.
  • Have compromised immune system or active hepatitis infection.
  • Have previously taken PARP inhibitors or certain other cancer drugs.
  • Have taken strong medications that affect liver enzymes recently.
  • Have had major surgery recently or participated in another clinical trial recently.
  • Have allergies to study drugs or their components.
  • Are involved in the study's planning or conduct.

Locations

FACILITYZIPCITYSTATE
Research Site35209BirminghamAlabama
Research Site99503AnchorageAlaska
Research Site85704TucsonArizona
Research Site85741TucsonArizona
Research Site93611ClovisCalifornia
Research Site90027Los AngelesCalifornia
Research Site90073Los AngelesCalifornia
Research Site95817SacramentoCalifornia
Research Site92123San DiegoCalifornia
Research Site80211DenverColorado

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