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Adding PARP Inhibitor to Enzalutamide to Treat Men with Metastatic Prostate Cancer that is Resistant to Anti-androgen Therapy

Clinicaltrials.gov identifier:
NCT04455750

Treatment
Treatment study for men with metastatic prostate cancer

Study Contact Information:

For additional information, please contact:
Arpit Rao, MD 713-798-4508 [email protected]

Adding PARP Inhibitor to Enzalutamide to Treat Men with Metastatic Prostate Cancer that is Resistant to Anti-androgen Therapy

About this Study

This study is testing the effectiveness of adding a type of known as a to androgen-deprivation therapy for men with prostate cancer that has become resistant to standard .

Type of Study:

This is a phase 3, , controlled clinical trial. controlled means that one group will receive the study drug combination (anti-androgen therapy drug, enzalutamide, and ) and the second group will receive standard of care treatment (anti-androgen therapy, enzalutamide) and a sugar pill. The trial is and , meaning participants are placed into one of the two study groups by chance. Neither patients nor their research doctor choose the group into which the participants are placed. Further, neither the participants nor the researchers will know which group is receiving the drug combination and which group is receiving the sugar pill with standard therapy. 

What the Study Involves

Participants will be randomly assigned to one of two groups.

  • Group 1 will receive (orally) enzalutamide (standard-of-care therapy) once a day and the ,  twice daily orally.
  • Group 2 will receive (orally) enzalutamide (standard-of-care therapy) once a day and a (sugar pill) twice daily orally.

Participants who have not had removal of both testicles will receive additional therapy consisting of leuprolide acetate IM, goserelin acetate SC every 12 weeks or degarelix SC).

Each cycle will be repeated every 28 days unless there is disease progression or adverse side effects. Crossover between groups is not allowed. Participants will be followed for up to 5 years after treatment is completed. 

Study Sites

The study is open at sites in the following states (see clinicaltrials.gov for complete listing of enrolling sites):

California

  • Open at Kaiser Permanente in multiple cities.
  • For all sites, contact: 877-642-4691 or [email protected] 

Colorado

  • Enrolling in:
    • Colorado Springs
    • Denver
    • Longmont.
  • For all sites, contact: 719-776-6550  or [email protected]

Connecticut

  • New Haven
    Veterans Affairs Connecticut Healthcare System-West Haven Campus
    Contact: 203-937-3421 ext. 2832

District of Columbia

  • MedStar Washington Hospital Center
    Contact: 202-877-8839

Georgia

  • Augusta
    Augusta Oncology Associates PC-D'Antignac
    Contact: 706-821-2944
  • Savannah
    Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    Contact: 912-819-5704 or: [email protected] 

Hawaii

Idaho

Illinois

Indiana

  • Richmond
    Reid Health
    Contact: 937-528-2900 or [email protected]
  • Southbend
    Memorial Hospital of South Bend
    Contact: 800-284-7379

Iowa

Maine

  • Augusta
    Harold Alfond Center for Cancer Care
    Contact: 207-626-4855

Michigan

Minnesota

Missouri

Montana

Nevada

New Hampshire

  • Concord
    New Hampshire Oncology
    Contact: 603-224-2556
  • Lebanon
    Dartmouth Hitchcock Medical Center
    Contact: 800-639-6918 or [email protected]
  • Manchester
    Solinsky Center for Cancer Care
    Contact: 800-339-6484

New Mexico

  • Albuquerque
    University of New Mexico Cancer Center
    505-925-0366    [email protected] 
  • Albuquerque
    Presbyterian Kaseman Hospital
    505-559-6113 or [email protected]
  • Rio Rancho
    Presbyterian Rust Medical Center/Jorgensen Cancer Center
    505-559-6113 or [email protected]

New York

  • Open in multiple sites
  • Bronx
    Contact: 718-379-6866 or [email protected]
  • Flushing
    New York Medical Center of Queens
    Contact: 888-823-5923 or [email protected] 
  • NYC
    • NYP/Weill Cornell Medical Center
      Contact: 212-746-1848
    • Queens Hospital Center
      Contact: 718-883-3000
  • Nyack
    Nyack Hospital
    845-348-8507 

North Carolina

North Dakota

Ohio

Oklahoma

  • Lawton
    Cancer Centers of Southwest Oklahoma Research
    Contact: 877-231-4440
  • Oklahoma City
    University of Oklahoma Health Sciences Center
    Contact: 405-271-8777 or [email protected]
  • Tulsa
    Oklahoma Cancer Specialists and Research Institute
    Contact: 918-505-3200

Pennsylvania

  • Allentown
    Lehigh Valley Hospital-Cedar Crest
    Contact: 610-402-9543 or [email protected]
  • Bethlehem
    Lehigh Valley Hospital-Muhlenberg
    Contact: 610-402-9543 or [email protected]
  • Sayre
    Guthrie Medical Group PC-Robert Packer Hospital
    Contact: 800-836-0388

South Carolina

  • Open in multiple sites
  • Contact: 864-241-6251

South Dakota

Texas

  • Houston
    Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    Contact:  713-798-1354 or [email protected]
  • Houston
    Ben Taub General Hospital
    Contact: 713-873-2000
  • Houston
    Michael E DeBakey VA Medical Center
    Contact: 800-553-2278

Utah

Vermont

  • Saint Johnsbury
    Norris Cotton Cancer Center
    Contact: 802-473-4100

Washington

West Virginia

  • Charleston
    West Virginia University Charleston Division
    Contact: 304-388-9944

Wisconsin

This Study is Open To:

Men 18 years and older who:

  • have a diagnosis of prostate cancer ()
  • have been treated (unsuccessfully) with anti-androgen therapy
  • have not undergone prior therapy for prostate cancer
  • must have access to tumor samples for genetic testing

*contact your doctors or the study coordinators for a complete list of inclusion criteria.

 

This Study is Not Open To:

Men with the following cannot participate:

  • CNS (brain/spine) metastases
  • have previously been treated with a
  • have already received treatment for prostate cancer

*contact your doctors or the study coordinators for a complete list of exclusion criteria.