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

Completed · Phase 3

Conditions studied: Metastatic Castration-resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02987543

Run by

AstraZeneca

People needed

387

Starts

2017-02-06

Expected to finish

2023-02-15

Last updated by the study team

2023-10-06

Who can join

Age: 18 and older, up to 130. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Duarte, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Barbara, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Jeffersonville, Indiana, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Towson, Maryland, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Albany, New York, United States
• Research Site — Brooklyn, New York, United States
• Research Site — Syracuse, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Salisbury, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Springfield, Oregon, United States
• Research Site — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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