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Completed Phase 1Phase 2 Interventional Results available

Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring

ClinicalTrials.gov ID: NCT04037254

Public ClinicalTrials.gov record NCT04037254. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 2:08 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized Phase II Trial of Niraparib With Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) (NADIR*) *Randomized Phase II Trial of Niraparib With Standard Combination Androgen DeprIvation Therapy (ADT) and Radiotherapy in High Risk Prostate Cancer (With Initial Phase I)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a phase I-II trial to find the safety and activity of adding a new drug (neraparib) to the usual treatment (radiation combined with male hormone deprivation therapy) in lowering the chance of prostate cancer growing or returning. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding niraparib to the usual care may lower the chance of prostate cancer growing or returning.

Study identification

NCT ID
NCT04037254
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
NRG Oncology
Other
Enrollment
22 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 8, 2019 (Actual)
Primary completion
Jul 1, 2024 (Actual)
Completion
Dec 23, 2025 (Actual)
Last update posted
Jul 10, 2026

2019 – 2025

United States locations

U.S. sites
94
U.S. states
22
U.S. cities
80
Facility City State ZIP Site status
Banner MD Anderson Cancer Center Gilbert Arizona 85234 —
University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona 85704 —
University of Arizona Cancer Center-North Campus Tucson Arizona 85719 —
City of Hope Comprehensive Cancer Center Duarte California 91010 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
Fremont - Rideout Cancer Center Marysville California 95901 —
University of California Davis Comprehensive Cancer Center Sacramento California 95817 —
City of Hope Upland Upland California 91786 —
Helen F Graham Cancer Center Newark Delaware 19713 —
Medical Oncology Hematology Consultants PA Newark Delaware 19713 —
George Washington University Medical Center Washington D.C. District of Columbia 20037 —
Grady Health System Atlanta Georgia 30303 —
Emory University Hospital/Winship Cancer Institute Atlanta Georgia 30322 —
Emory Saint Joseph's Hospital Atlanta Georgia 30342 —
CTCA at Southeastern Regional Medical Center Newnan Georgia 30265 —
Alton Memorial Hospital Alton Illinois 62002 —
Northwestern University Chicago Illinois 60611 —
Rush MD Anderson Cancer Center Chicago Illinois 60612 —
Carle Cancer Center Urbana Illinois 61801 —
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa 52242 —
University of Kansas Cancer Center Kansas City Kansas 66160 —
University of Kansas Cancer Center-Overland Park Overland Park Kansas 66210 —
University of Kansas Hospital-Westwood Cancer Center Westwood Kansas 66205 —
University of Maryland/Greenebaum Cancer Center Baltimore Maryland 21201 —
Central Maryland Radiation Oncology in Howard County Columbia Maryland 21044 —
UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland 21061 —
Massachusetts General Hospital Cancer Center Boston Massachusetts 02114 —
McLaren Cancer Institute-Bay City Bay City Michigan 48706 —
Henry Ford Cancer Institute-Downriver Brownstown Michigan 48183 —
McLaren Cancer Institute-Clarkston Clarkston Michigan 48346 —
Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan 48038 —
Henry Ford Medical Center-Fairlane Dearborn Michigan 48126 —
Wayne State University/Karmanos Cancer Institute Detroit Michigan 48201 —
Henry Ford Hospital Detroit Michigan 48202 —
Weisberg Cancer Treatment Center Farmington Hills Michigan 48334 —
McLaren Cancer Institute-Flint Flint Michigan 48532 —
Singh and Arora Hematology Oncology PC Flint Michigan 48532 —
Karmanos Cancer Institute at McLaren Greater Lansing Lansing Michigan 48910 —
Mid-Michigan Physicians-Lansing Lansing Michigan 48912 —
McLaren Cancer Institute-Lapeer Region Lapeer Michigan 48446 —
McLaren Cancer Institute-Macomb Mount Clemens Michigan 48043 —
Henry Ford Medical Center-Columbus Novi Michigan 48377 —
McLaren Cancer Institute-Northern Michigan Petoskey Michigan 49770 —
McLaren-Port Huron Port Huron Michigan 48060 —
Henry Ford Macomb Health Center - Shelby Township Shelby Michigan 48315 —
Henry Ford West Bloomfield Hospital West Bloomfield Michigan 48322 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters Missouri 63376 —
Siteman Cancer Center at West County Hospital Creve Coeur Missouri 63141 —
University of Kansas Cancer Center - North Kansas City Missouri 64154 —
University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri 64064 —
Washington University School of Medicine St Louis Missouri 63110 —
Siteman Cancer Center-South County St Louis Missouri 63129 —
Benefis Sletten Cancer Institute Great Falls Montana 59405 —
AtlantiCare Health Park-Cape May Court House Cape May Court House New Jersey 08210 —
AtlantiCare Surgery Center Egg Harbor New Jersey 08234 —
Rutgers New Jersey Medical School Newark New Jersey 07101 —
Holy Name Hospital Teaneck New Jersey 07666 —
Roswell Park Cancer Institute Buffalo New York 14263 —
The New York Hospital Medical Center of Queens Flushing New York 11355 —
Highland Hospital Rochester New York 14620 —
University of Rochester Rochester New York 14642 —
Stony Brook University Medical Center Stony Brook New York 11794 —
Summa Health System - Akron Campus Akron Ohio 44304 —
Summa Health System - Barberton Campus Barberton Ohio 44203 —
University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio 45219 —
Case Western Reserve University Cleveland Ohio 44106 —
Summa Health Medina Medical Center Medina Ohio 44256 —
University of Cincinnati Cancer Center-West Chester West Chester Ohio 45069 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania 19317 —
Geisinger Medical Center Danville Pennsylvania 17822 —
Penn State Milton S Hershey Medical Center Hershey Pennsylvania 17033-0850 —
Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania 17837 —
Lewistown Hospital Lewistown Pennsylvania 17044 —
Eastern Regional Medical Center Philadelphia Pennsylvania 19124 —
University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania 15232 —
UPMC-Shadyside Hospital Pittsburgh Pennsylvania 15232 —
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania 18711 —
Medical University of South Carolina Charleston South Carolina 29425 —
Prisma Health Cancer Institute - Faris Greenville South Carolina 29605 —
Saint Francis Cancer Center Greenville South Carolina 29607 —
Prisma Health Cancer Institute - Eastside Greenville South Carolina 29615 —
Self Regional Healthcare Greenwood South Carolina 29646 —
Prisma Health Cancer Institute - Greer Greer South Carolina 29650 —
Prisma Health Cancer Institute - Seneca Seneca South Carolina 29672 —
West Virginia University Healthcare Morgantown West Virginia 26506 —
Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin 53051 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —
Zablocki Veterans Administration Medical Center Milwaukee Wisconsin 53295 —
Drexel Town Square Health Center Oak Creek Wisconsin 53154 —
ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin 53066 —
UW Cancer Center at ProHealth Care Waukesha Wisconsin 53188 —
Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin 53095 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04037254, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 10, 2026 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04037254 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →