New drug combo aims to stop high-risk prostate cancer in its tracks

NCT ID NCT04037254

Disease control Sponsor: NRG Oncology Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tested whether adding the drug niraparib to standard radiation and hormone therapy can help prevent high-risk prostate cancer from coming back. Niraparib blocks a protein that cancer cells use to repair their DNA, which may kill them. The trial enrolled 22 men with aggressive prostate cancer and followed them for two years to see if their PSA levels stayed low.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: niraparib
What this could lead to: If successful, adding niraparib to standard care could lower the chance of high-risk prostate cancer growing or coming back after treatment.
What could go wrong: This is a small early-phase trial with only 22 participants, so results may not apply broadly. Niraparib can cause side effects like fatigue, nausea, and low blood counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

22 people

The number who actually took part.

Started

Oct 2019

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed (within 180 days prior to registration) adenocarcinoma of the prostate at high risk for recurrence as determined by the following criteria, according to American Joint Committee on Cancer (AJCC) 8th edition: * Phase I enrollment * Gleason \>= 9, PSA =\< 150 ng/mL, any T-stage * Phase II enrollment * Gleason \>= 9, PSA =\< 150 ng/mL, any T-stage * Gleason 8, PSA \< 20 ng/mL, and \>= T2 * Gleason 8, PSA \>= 20-150 ng/mL, any T-stage * Gleason 7, PSA \>= 20-150 ng/mL, any T-stage * No distant metastases as evaluated by: * Bone scan 90 days prior to registration * Lymph node assessment by computed tomography (CT) or magnetic resonance (MR) of pelvis or nodal sampling within 90 days prior to registration (Please note: Lymph nodes will be considered negative \[N0\] if they are \< 1.5 cm short axis) * History/physical examination within 90 days prior to registration * Age \>= 18 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 180 days prior to registration * Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration * Phase I patients: Prior androgen suppression for prostate cancer is not allowed prior to registration * Phase II patients: Prior androgen suppression for prostate cancer is allowed =\< 45 days prior to registration * Hemoglobin \>= 9.0 g/dL (within 90 days prior to registration) * Platelets \>= 100,000 cells/mm\^3 (within 90 days prior to registration) * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (within 90 days prior to registration) * Serum creatinine =\<1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance \>= 30 mL/min estimated using Cockcroft-Gault equation (within 90 days prior to registration) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 x ULN (within 90 days prior to registration) * Serum albumin \>= 3 g/dL (within 90 days prior to registration) * Serum potassium \>= 3.5 mmol/L (within 90 days prior to registration) * Serum total bilirubin =\< 1.5 x ULN or direct bilirubin =\< 1 x ULN (Note: in subjects with Gilberts syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is =\< 1.5 x ULN, subject may be eligible) (within 90 days prior to registration) * Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry Exclusion Criteria: * PSA \> 150 ng/mL * Definitive clinical or radiologic evidence of metastatic disease * Pathologically positive lymph nodes or nodes \> 1.5 cm short axis on CT or MR imaging * Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason * Any active malignancy within 2 years of study registration that may alter the course of prostate cancer treatment * Prior systemic therapy for prostate cancer; note that prior therapy for a different cancer is allowable * Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields * Current treatment with first generation anti-androgens (bicalutamide, nilutamide, flutamide). For patients enrolled to phase II, if prior anti-androgens were administered, a washout period of \>= 30 days is required prior to enrollment * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Uncontrolled acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition * Presence of uncontrolled hypertension (persistent systolic blood pressure \[BP\] \>=160 mmHg or diastolic BP \>= 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment * Prior allergic reaction to the drugs involved in this protocol (including known allergies, hypersensitivity or intolerance to the excipients of niraparib) * Human immunodeficiency virus (HIV) positive with CD4 count \< 200 cells/microliter * Note that patients who are HIV positive are eligible, provided they have a CD4 count \>= 200 cells/microliter within 90 days prior to registration. Patients receiving treatment with highly active antiretroviral therapy (HAART) will not be eligible due to concern for radiosensitization * Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be affected by these drugs * Any history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) * Prior or current treatment with PARP inhibitor

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate adenocarcinoma Stage IIC prostate cancer ajcc V8 Stage III prostate cancer ajcc V8 Stage IIIA prostate cancer ajcc V8 Stage IIIB prostate cancer ajcc V8 Stage IIIC prostate cancer ajcc V8 Stage IVA prostate cancer ajcc V8

Contacts and locations

Locations

Alton Memorial Hospital

Alton, Illinois, 62002, United States
Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada
AtlantiCare Health Park-Cape May Court House

Cape May Court House, New Jersey, 08210, United States
AtlantiCare Surgery Center

Egg Harbor, New Jersey, 08234, United States
Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States
Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States
CTCA at Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Case Western Reserve University

Cleveland, Ohio, 44106, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044, United States
Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
City of Hope Upland

Upland, California, 91786, United States
Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154, United States
Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States
Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Fremont - Rideout Cancer Center

Marysville, California, 95901, United States
Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States
Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095, United States
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States
Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States
George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States
Grady Health System

Atlanta, Georgia, 30303, United States
Helen F Graham Cancer Center

Newark, Delaware, 19713, United States
Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Henry Ford Macomb Health Center - Shelby Township

Shelby, Michigan, 48315, United States
Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States
Henry Ford Medical Center-Columbus

Novi, Michigan, 48377, United States
Henry Ford Medical Center-Fairlane

Dearborn, Michigan, 48126, United States
Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States
Highland Hospital

Rochester, New York, 14620, United States
Holy Name Hospital

Teaneck, New Jersey, 07666, United States
Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910, United States
Lewistown Hospital

Lewistown, Pennsylvania, 17044, United States
Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States
McLaren Cancer Institute-Bay City

Bay City, Michigan, 48706, United States
McLaren Cancer Institute-Clarkston

Clarkston, Michigan, 48346, United States
McLaren Cancer Institute-Flint

Flint, Michigan, 48532, United States
McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, 48446, United States
McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, 48043, United States
McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, 49770, United States
McLaren-Port Huron

Port Huron, Michigan, 48060, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Mid-Michigan Physicians-Lansing

Lansing, Michigan, 48912, United States
Northwestern University

Chicago, Illinois, 60611, United States
Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States
Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States
ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Rush MD Anderson Cancer Center

Chicago, Illinois, 60612, United States
Rutgers New Jersey Medical School

Newark, New Jersey, 07101, United States
Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States
Self Regional Healthcare

Greenwood, South Carolina, 29646, United States
Singh and Arora Hematology Oncology PC

Flint, Michigan, 48532, United States
Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States
Stony Brook University Medical Center

Stony Brook, New York, 11794, United States
Summa Health Medina Medical Center

Medina, Ohio, 44256, United States
Summa Health System - Akron Campus

Akron, Ohio, 44304, United States
Summa Health System - Barberton Campus

Barberton, Ohio, 44203, United States
The New York Hospital Medical Center of Queens

Flushing, New York, 11355, United States
UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061, United States
UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States
UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States
University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, 85704, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States
University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States
University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States
University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States
University of Rochester

Rochester, New York, 14642, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States
West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States
Zablocki Veterans Administration Medical Center

Milwaukee, Wisconsin, 53295, United States

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