NRG GU007: Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer (NADIR)

About this Study

The purpose of this study is to study the side effects and determine the 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). 

Sponsor Protocol ID:NRG GU007
IRB Number:2019-0199
Actively Enrolling
Phase 2
June 15, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Histologically confirmed adenocarcinoma of the prostate at high risk for recurrence
  • No distant metastases
  • Must be willing to consent to use of effective birth control while on treatment and at least 3 months afterwards

Exclusion Criteria
  • PSA that is greater than 150 ng/mL
  • Clinical or radiologic evidence of metastatic disease
  • Pathologically positive lymph nodes or nodes greater than 1.5 cm on CT or MR imaging
  • Prior radical prostatectomy, cryosurgery for prostate cancer , or bilateral orchiectomy for any reason
  • Any other active cancer within 2 years of study registration
  • Prior systemic therapy for prostate cancer
  • Prior radiotherapy, including brachytherapy
  • Current treatment with anti-androgens (bicalutamide, nilutamide, flutamide)
  • Severe, active co-morbidity such as unstable angina and/or congestive heart failure (CHF), myocardial infarction within the last six months, acute bacterial or fungal infection requiring IV antibiotics at the time of registration, uncontrolled AIDS, and uncontrolled high blood pressure
  • HIV positive with CD4 count less than 200 cells/microliter
  • Any history or current diagnosis of Myelodysplastic Syndromes (MDS)/Acute Myeloid Leukemia (AML)
  • Prior or current treatment with PARP inhibitor, rucaparib (Rubraca) and olaparib (Lynparza)

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Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Eulisa Goins-Freeman
Phone Number: 601-815-3936
Principal Investigator:Henegan, John C, M.D.
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