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
NCT ID: NCT04037254
Last Updated: 2025-07-28
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2019-10-08
2025-09-26
Brief Summary
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Detailed Description
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I. To establish the preferred dose of niraparib in combination with radiation and antiandrogen therapy (ADT). (Phase I) II. To compare the disease-free state, defined as prostate specific antigen (PSA) remaining \< 0.1 ng/ml at the end of ADT therapy in men with high risk prostate cancer treated with standard therapy with or without the addition of niraparib. (Phase IIR)
SECONDARY OBJECTIVES:
I. To further establish the safety and toxicity profile of standard treatment with radiation and androgen deprivation therapy specifically, two years from initiation of ADT, plus niraparib at the phase II dose.
II. To compare the overall survival, prostate cancer-specific survival, local/regional or distant progression, and distant metastatic disease rates of standard therapy with or without the addition of niraparib.
EXPLORATORY OBJECTIVE:
I. To identify genomic biomarkers of response to combination therapy with radiation, ADT and PARP inhibition.
OUTLINE: This is a phase I, dose-escalation study of niraparib, followed by a randomized phase II study.
PHASE I: Patients receive niraparib orally (PO) once daily (QD) and receive standard of care gonadotrophin releasing hormone (GnRH) agonist androgen suppression therapy. Treatment with niraparib continues for 12 months, and GnRH agonist therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib and GnRH agonist, patients undergo standard of care intensity-modulated radiation therapy (IMRT) 5 days per week for about 6-9 weeks, depending on type of radiation therapy given, in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) on study.
PHASE II: Patients are randomized to 1 of 2 arms:
ARM I: Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI on study.
ARM II: Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI on study.
After completion of study treatment, patients are followed up every 6 months for 3 years, then annually for 3 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase I, Dose Level 1 (niraparib, GnRH, IMRT)
Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity.
\*Niraparib dose level 1: 100 mg.
Gonadotrophin Releasing Hormone
Receive standard of care GnRH agonist androgen suppression therapy
Intensity-Modulated Radiation Therapy
Undergo standard of care IMRT
Niraparib
tablet
Phase I, Dose Level 2 (niraparib, GnRH, IMRT)
Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity.
\*Niraparib dose level 2: 100 mg during IMRT 200 mg otherwise.
Gonadotrophin Releasing Hormone
Receive standard of care GnRH agonist androgen suppression therapy
Intensity-Modulated Radiation Therapy
Undergo standard of care IMRT
Niraparib
tablet
Phase I, Dose Level 3 (niraparib, GnRH, IMRT)
Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment given in the absence of disease progression or unacceptable toxicity.
\*Niraparib dose level 3: 200 mg.
Gonadotrophin Releasing Hormone
Receive standard of care GnRH agonist androgen suppression therapy
Intensity-Modulated Radiation Therapy
Undergo standard of care IMRT
Niraparib
tablet
Phase II, Arm I (GnRH, IMRT)
Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity.
Gonadotrophin Releasing Hormone
Receive standard of care GnRH agonist androgen suppression therapy
Intensity-Modulated Radiation Therapy
Undergo standard of care IMRT
Phase II, Arm II (niraparib, GnRH, IMRT)
Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD (phase I determined dose level) for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity.
Gonadotrophin Releasing Hormone
Receive standard of care GnRH agonist androgen suppression therapy
Intensity-Modulated Radiation Therapy
Undergo standard of care IMRT
Niraparib
tablet
Interventions
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Gonadotrophin Releasing Hormone
Receive standard of care GnRH agonist androgen suppression therapy
Intensity-Modulated Radiation Therapy
Undergo standard of care IMRT
Niraparib
tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Responsible Party
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Principal Investigators
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M. D Michaelson
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
City of Hope Upland
Upland, California, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Grady Health System
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, United States
Alton Memorial Hospital
Alton, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
McLaren Cancer Institute-Bay City
Bay City, Michigan, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, United States
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
McLaren Cancer Institute-Flint
Flint, Michigan, United States
Singh and Arora Hematology Oncology PC
Flint, Michigan, United States
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States
Mid-Michigan Physicians-Lansing
Lansing, Michigan, United States
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, United States
McLaren-Port Huron
Port Huron, Michigan, United States
Henry Ford Macomb Health Center - Shelby Township
Shelby, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
AtlantiCare Health Park-Cape May Court House
Cape May Court House, New Jersey, United States
AtlantiCare Surgery Center
Egg Harbor, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Holy Name Hospital
Teaneck, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
The New York Hospital Medical Center of Queens
Flushing, New York, United States
Highland Hospital
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Summa Health System - Akron Campus
Akron, Ohio, United States
Summa Health System - Barberton Campus
Barberton, Ohio, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Summa Health Medina Medical Center
Medina, Ohio, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Saint Francis Cancer Center
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2019-02260
Identifier Type: REGISTRY
Identifier Source: secondary_id
NRG-GU007
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-GU007
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-GU007
Identifier Type: -
Identifier Source: org_study_id
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