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Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

NCT02987543 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2023-10-06

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.

Conditions

Interventions

DRUG

olaparib

300 mg (2x 150 mg tablets) twice daily

DRUG

enzalutamide

160 mg (4 x 40 mg capsules) once daily

DRUG

abiraterone acetate

1,000 mg (4 x 250 mg tablets) once daily

DRUG

abiraterone acetate

1,000 mg (2 x 500 mg tablets) once daily

DRUG

enzalutamide

160 mg (4 x 40 mg tablets) once daily

Sponsors & Collaborators

Principal Investigators

  • Johann de Bono, M.D., Ph.D. · The Institute of Cancer Research, United Kingdom

  • Maha Hussain, M.D., FACP, FASCO · Northwestern University, United States of America

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2019-06-04
Completion
2023-02-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Norway
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02987543 on ClinicalTrials.gov