
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
- Open in multiple cities in Hawaii.
- Contact: 808-524-6115 or [email protected]
Idaho
- Open in multiple cities in Idaho
- Contact: 734-712-3671 or [email protected], or
- Contact: 208-381-2774 or [email protected]
Illinois
- Open in multiple cities in Illinois.
- Contact: 309-243-3605 or [email protected], or
- Contact: 217-876-4762 [email protected]
Indiana
- Richmond
Reid Health
Contact: 937-528-2900 or [email protected] - Southbend
Memorial Hospital of South Bend
Contact: 800-284-7379
Iowa
- Open in multiple cities
- Contact: 515-239-4734 [email protected]
Maine
- Augusta
Harold Alfond Center for Cancer Care
Contact: 207-626-4855
Michigan
- Open in multiple cities
- Contact: 734-712-7251 or [email protected], or
- Contact: 313-343-3166 or [email protected], or
- 810-762-8038 or [email protected]
Minnesota
- Open in multiple cities
- Contact: 952-993-1517 or [email protected], or
- Contact: 218-333-5000 or [email protected], or
- Contact: 605-312-3320
Missouri
- Open in multiple cities
- Contact: 314-996-5569 or [email protected]
Montana
- Open in multiple cities
- Contact: 406-969-6060 or [email protected]
Nevada
- Las Vegas
- Contact: 702-384-0013 or [email protected]
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
- NYP/Weill Cornell Medical Center
- Nyack
Nyack Hospital
845-348-8507
North Carolina
- Open in multiple sites
- Contact: 888-823-5923 or [email protected]
North Dakota
- Fargo
Contact: 701-234-6161 or [email protected]
Ohio
- Columbus
James Cancer Center
Contact: 800-293-5066 or [email protected] - Open in multiple sites
- Contact: 937-528-2900 or [email protected], or
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
- Open in multiple sites
- Contact: 605-622-8700 or [email protected], or
- Contact: 605-312-3320 or [email protected]
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
- Salt Lake City
Huntsman Cancer Institute
888-424-2100 [email protected]
Vermont
- Saint Johnsbury
Norris Cotton Cancer Center
Contact: 802-473-4100
Washington
- Open in multiple sites
- Contact: 509-783-4637 or [email protected], or
- Contact: 425-899-6000, or
- Contact: 425-228-3440 or [email protected], or
- Contact: 360-514-3940 or [email protected]
West Virginia
- Charleston
West Virginia University Charleston Division
Contact: 304-388-9944
Wisconsin
- Open in multiple sites
- Contact: 414-302-2304 or [email protected]
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.
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.