Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer (NADIR)

February 5, 2024 updated by: NRG Oncology

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

This phase II trial studies the side effects and best dose of niraparib, and to see how well it works in combination with standard of care radiation therapy and hormonal therapy (androgen deprivation therapy) in treating patients with prostate cancer that has a high chance of coming back (high risk). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding niraparib to the usual treatments of radiation therapy and hormonal therapy may lower the chance of prostate cancer growing or returning.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

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 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 OBJECTIVES:

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 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.

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.

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.

After completion of study treatment, patients are followed up every 6 months for 3 years, then annually for 3 years.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Tucson, Arizona, United States, 85704
        • University of Arizona Cancer Center-Orange Grove Campus
      • Tucson, Arizona, United States, 85719
        • University of Arizona Cancer Center-North Campus
    • California
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Marysville, California, United States, 95901
        • Fremont - Rideout Cancer Center
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • Upland, California, United States, 91786
        • City of Hope Upland
    • Delaware
      • Newark, Delaware, United States, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants PA
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
      • Newnan, Georgia, United States, 30265
        • CTCA at Southeastern Regional Medical Center
    • Illinois
      • Alton, Illinois, United States, 62002
        • Alton Memorial Hospital
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center-Overland Park
      • Westwood, Kansas, United States, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Columbia, Maryland, United States, 21044
        • Central Maryland Radiation Oncology in Howard County
      • Glen Burnie, Maryland, United States, 21061
        • UM Baltimore Washington Medical Center/Tate Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Bay City, Michigan, United States, 48706
        • McLaren Cancer Institute-Bay City
      • Brownstown, Michigan, United States, 48183
        • Henry Ford Cancer Institute-Downriver
      • Clarkston, Michigan, United States, 48346
        • McLaren Cancer Institute-Clarkston
      • Clinton Township, Michigan, United States, 48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn, Michigan, United States, 48126
        • Henry Ford Medical Center-Fairlane
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Weisberg Cancer Treatment Center
      • Flint, Michigan, United States, 48532
        • McLaren Cancer Institute-Flint
      • Flint, Michigan, United States, 48532
        • Singh and Arora Hematology Oncology PC
      • Lansing, Michigan, United States, 48912
        • Mid-Michigan Physicians-Lansing
      • Lansing, Michigan, United States, 48910
        • Karmanos Cancer Institute at McLaren Greater Lansing
      • Lapeer, Michigan, United States, 48446
        • McLaren Cancer Institute-Lapeer Region
      • Mount Clemens, Michigan, United States, 48043
        • McLaren Cancer Institute-Macomb
      • Novi, Michigan, United States, 48377
        • Henry Ford Medical Center-Columbus
      • Petoskey, Michigan, United States, 49770
        • McLaren Cancer Institute-Northern Michigan
      • Port Huron, Michigan, United States, 48060
        • McLaren-Port Huron
      • Shelby, Michigan, United States, 48315
        • Henry Ford Macomb Health Center - Shelby Township
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford West Bloomfield Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center at West County Hospital
      • Kansas City, Missouri, United States, 64154
        • University of Kansas Cancer Center - North
      • Lee's Summit, Missouri, United States, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63129
        • Siteman Cancer Center-South County
      • Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center at Saint Peters Hospital
    • Montana
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare- Sletten Cancer Institute
    • New Jersey
      • Cape May Court House, New Jersey, United States, 08210
        • AtlantiCare Health Park-Cape May Court House
      • Egg Harbor Township, New Jersey, United States, 08234
        • AtlantiCare Surgery Center
      • Newark, New Jersey, United States, 07101
        • Rutgers New Jersey Medical School
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Hospital
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Flushing, New York, United States, 11355
        • The New York Hospital Medical Center of Queens
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rochester, New York, United States, 14620
        • Highland Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System - Akron Campus
      • Barberton, Ohio, United States, 44203
        • Summa Health System - Barberton Campus
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Medina, Ohio, United States, 44256
        • Summa Health Medina Medical Center
      • West Chester, Ohio, United States, 45069
        • University of Cincinnati Cancer Center-West Chester
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Christiana Care Health System-Concord Health Center
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Lewisburg, Pennsylvania, United States, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Lewistown, Pennsylvania, United States, 17044
        • Lewistown Hospital
      • Philadelphia, Pennsylvania, United States, 19124
        • Eastern Regional Medical Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC-Shadyside Hospital
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, United States, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenwood, South Carolina, United States, 29646
        • Self Regional Healthcare
      • Greer, South Carolina, United States, 29650
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, United States, 29672
        • Prisma Health Cancer Institute - Seneca
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Healthcare
    • Wisconsin
      • Menomonee Falls, Wisconsin, United States, 53051
        • Froedtert Menomonee Falls Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Zablocki Veterans Administration Medical Center
      • Oak Creek, Wisconsin, United States, 53154
        • Drexel Town Square Health Center
      • Oconomowoc, Wisconsin, United States, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Waukesha, Wisconsin, United States, 53188
        • UW Cancer Center at ProHealth Care
      • West Bend, Wisconsin, United States, 53095
        • Froedtert West Bend Hospital/Kraemer Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • 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. Please see Niraparib IB for details.)

  • 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 Myelodysplasitc Syndromes (MDS)/ Acute Myeloid Leukemia (AML).
  • Prior or current treatment with PARP inhibitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I (niraparib, GnRH, IMRT)
Patients receive niraparib PO QD and receive standard of care 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 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.
Drug: Niraparib
Given PO
Other Names:
  • MK-4827
  • MK4827
Biological: Gonadotrophin Releasing Hormone
Receive standard of care GnRH agonist androgen suppression therapy
Other Names:
  • GnRH
  • gonadotropin-releasing hormone
  • LHRH
  • Luliberin
  • Gonadorelin
  • AY-24031
  • D-His-6-Pro-8-NEt-LHRH
  • Follicle Stimulating Hormone-Releasing Factor
  • GN-RH
  • Gonadoliberin
  • Gonadorelinum
  • Hoe- 471
  • LH-RF
  • LH-RH
  • LH/FSH-RF
  • LH/FSH-RH
  • Luteinising Hormone-Releasing Factor
  • Luteinizing Hormone-Releasing Factor
  • luteinizing hormone-releasing hormone
Radiation: Intensity-Modulated Radiation Therapy
Undergo standard of care IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Active Comparator: Phase II, Arm I (GnRH, IMRT)
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.
Biological: Gonadotrophin Releasing Hormone
Receive standard of care GnRH agonist androgen suppression therapy
Other Names:
  • GnRH
  • gonadotropin-releasing hormone
  • LHRH
  • Luliberin
  • Gonadorelin
  • AY-24031
  • D-His-6-Pro-8-NEt-LHRH
  • Follicle Stimulating Hormone-Releasing Factor
  • GN-RH
  • Gonadoliberin
  • Gonadorelinum
  • Hoe- 471
  • LH-RF
  • LH-RH
  • LH/FSH-RF
  • LH/FSH-RH
  • Luteinising Hormone-Releasing Factor
  • Luteinizing Hormone-Releasing Factor
  • luteinizing hormone-releasing hormone
Radiation: Intensity-Modulated Radiation Therapy
Undergo standard of care IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Experimental: Phase II, Arm II (niraparib, GnRH, IMRT)
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.
Drug: Niraparib
Given PO
Other Names:
  • MK-4827
  • MK4827
Biological: Gonadotrophin Releasing Hormone
Receive standard of care GnRH agonist androgen suppression therapy
Other Names:
  • GnRH
  • gonadotropin-releasing hormone
  • LHRH
  • Luliberin
  • Gonadorelin
  • AY-24031
  • D-His-6-Pro-8-NEt-LHRH
  • Follicle Stimulating Hormone-Releasing Factor
  • GN-RH
  • Gonadoliberin
  • Gonadorelinum
  • Hoe- 471
  • LH-RF
  • LH-RH
  • LH/FSH-RF
  • LH/FSH-RH
  • Luteinising Hormone-Releasing Factor
  • Luteinizing Hormone-Releasing Factor
  • luteinizing hormone-releasing hormone
Radiation: Intensity-Modulated Radiation Therapy
Undergo standard of care IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance of disease-free state
Time Frame: Up to 2 years following the start of antiandrogen therapy
Will be characterized by PSA values sustained below 0.1 ng/ml. A modified intent-to-treat analysis will be conducted. The proportion of patients disease-free at 24 months will be compared in the two treatment arms using a non continuity-corrected chi-square test. As a secondary analysis, a logistic regression model will be fit to adjust for the stratification factors (risk group and type of radiation therapy).
Up to 2 years following the start of antiandrogen therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From randomization until death from any cause, assessed up to 3 years
Will consist of comparison of Kaplan-Meier (Kaplan 1958) curves using a logrank test.
From randomization until death from any cause, assessed up to 3 years
Prostate cancer-specific survival
Time Frame: From randomization until death from prostate cancer, assessed up to 3 years
Will consist of comparison of Kaplan-Meier (Kaplan 1958) curves using a logrank test.
From randomization until death from prostate cancer, assessed up to 3 years
Pathologic Complete Response (pCR)
Time Frame: At 24 months
Will be assessed among patients undergoing 12-core biopsy. Will be compared using a chi-square test.
At 24 months
Time to local/regional or distant progression
Time Frame: Up to 3 years
Cumulative incidence curves will be compared using the Fine-Gray test (Dignam 2008).
Up to 3 years
Time to distant metastases
Time Frame: From randomization until detection of distant metastatic disease, assessed up to 3 years
Cumulative incidence curves will be compared using the Fine-Gray test (Dignam 2008).
From randomization until detection of distant metastatic disease, assessed up to 3 years
Biochemical Progression-Free Survival
Time Frame: Up to 3 years
Will be defined as PSA >= 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or death from prostate cancer. Will consist of comparison of Kaplan-Meier (Kaplan 1958) curves using a logrank test.
Up to 3 years
Incidence of Adverse Events (Phase II)
Time Frame: Up to 3 years
Adverse event (AE) rates in the two treatment arms will be summarized by time of occurrence (early versus late), type, grade, and attribution to treatment. For each type of AE, the worst grade occurring during the early treatment period, late treatment period, or entire treatment period will be determined. For each time period, treatment group comparisons will be conducted using chi-square or Fisher exact tests.
Up to 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exome sequencing of deoxyribonucleic acid (DNA) repair genes and detected alterations
Time Frame: Up to 3 years
Descriptive statistics will be generated summarizing the frequency of gene alterations, mutations, and gene expression levels. The percentage of patients with baseline or post-therapy alterations in targeted genes will be reported and the association between the occurrence of reversion mutations in DNA repair genes and clinical outcomes will be assessed using logistic regression models for dichotomous endpoints (disease-free state, pCR), and Cox regression or competing risk regression modeling for time-to-event data.
Up to 3 years
Transcription-wide analysis of gene expression
Time Frame: Up to 3 years
Will be assessed using a high-density Affymetrix oligonucleotide array to profile the transcriptome of tumor samples. Descriptive statistics will be generated summarizing the frequency of gene alterations, mutations, and gene expression levels. The percentage of patients with baseline or post-therapy alterations in targeted genes will be reported and the association between the occurrence of reversion mutations in DNA repair genes and clinical outcomes will be assessed using logistic regression models for dichotomous endpoints (disease-free state, pCR), and Cox regression or competing risk regression modeling for time-to-event data.
Up to 3 years
Single nucleotide polymorphisms
Time Frame: Up to 3 years
Will be analyzed in whole blood samples previously associated with prostate risk. Plasma samples will be assessed for baseline and post-therapy alterations in a targeted gene panel and for reversion mutations in DNA repair genes as early biomarkers of treatment resistance. Descriptive statistics will be generated summarizing the frequency of gene alterations, mutations, and gene expression levels. The percentage of patients with baseline or post-therapy alterations in targeted genes will be reported and the association between the occurrence of reversion mutations in DNA repair genes and clinical outcomes will be assessed using logistic regression models for dichotomous endpoints (disease-free state, pCR), and Cox regression or competing risk regression modeling for time-to-event data.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NRG Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: M. D Michaelson, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2019

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

July 26, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRG-GU007 (Other Identifier: CTEP)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NCI-2019-02260 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Adenocarcinoma

Clinical Trials on Niraparib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe