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

Trial Status: Closed to Accrual

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.

Inclusion Criteria

  • Histologically confirmed diagnosis of prostate cancer.
  • Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
  • Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .
  • Ongoing therapy with LHRH analog or bilateral orchiectomy.
  • Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
  • Qualifying HRR mutation in tumor tissue.

Exclusion Criteria

  • Any previous treatment with PARP inhibitor, including olaparib.
  • Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose > 5 years prior to randomization.
  • Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥5 years.
  • Subjects with known brain metastases.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: COMPLETED

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE
Salisbury
WG Hefner VA Medical Center
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: COMPLETED
Contact: SCC Clinical Trials Office
Phone: 405-271-8777

South Carolina

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: COMPLETED

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: COMPLETED

This is a prospective, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of olaparib versus enzalutamide or abiraterone in subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior treatment with a new hormonal agent (NHA) and have a qualifying tumor mutation in one of 15 genes involved in the homologous recombination repair (HRR) pathway. Subjects will be divided into two cohorts based on HRR gene mutation status. Approximately 340 subjects will be randomized 2:1 (olaparib : investigator choice of enzalutamide or abiraterone acetate) into the trial.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D081DC00007
  • Secondary IDs NCI-2017-00284
  • Clinicaltrials.gov ID NCT02987543