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

Completed · Phase 1/Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT04037254
Run by: NRG Oncology
People needed: 22
Starts: 2019-10-08
Expected to finish: 2025-12-23
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

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 MD Anderson Cancer 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
Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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