NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT02987543

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: olaparib, enzalutamide, abiraterone acetate, abiraterone acetate, enzalutamide

Countries: United States, Argentina, Australia, Austria, Brazil, Canada, Denmark, France

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.

Eligibility overview

Sex: MALE

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria

1. Histologically confirmed diagnosis of prostate cancer.
2. Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
3. 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 .
4. Ongoing therapy with LHRH analog or bilateral orchiectomy.
5. Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
6. Qualifying HRR mutation in tumor tissue.

Exclusion criteria

1. Any previous treatment with PARP inhibitor, including olaparib.
2. 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.
3. 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.
4. Subjects with known brain metastases.

Locations (204)

Anchorage, Alaska, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Duarte, California, United States
San Diego, California, United States
Santa Barbara, California, United States
Washington D.C., District of Columbia, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Jeffersonville, Indiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Towson, Maryland, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Albany, New York, United States
Brooklyn, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Salisbury, North Carolina, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Springfield, Oregon, United States
Tualatin, Oregon, United States
Charleston, South Carolina, United States
Myrtle Beach, South Carolina, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
+ 174 more on CT.gov