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Phase 2 Completed N=22 Randomized Treatment

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

Prostate adenocarcinoma · Stage IIC Prostate Cancer AJCC v8 · Stage III Prostate Cancer AJCC v8 · Stage IIIA Prostate Cancer AJCC v8
Source: ClinicalTrials.gov NCT04037254 ↗
Enrolled (actual)
22
Serious AEs
52.9%
Results posted
Jul 2025
Primary outcomePrimary: Number of Participants Disease-free Until Completion of Treatment (2 Years From Start of ADT)

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Disease-free Until Completion of Treatment (2 Years From Start of ADT)
SECONDARY
Percent of Participants Alive (Overall Survival)
SECONDARY
Percentage of Participants With Prostate Cancer Deaths (Prostate Cancer-specific Survival)
SECONDARY
Percentage of Participants With Pathologic Complete Response (pCR) at Two Years
SECONDARY
Percentage of Participants With Local/Regional or Distant Progression
SECONDARY
Percentage of Participants With Distant Metastases
SECONDARY
Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)
SECONDARY
Number of Participants by Highest Grade Adverse Event Reported

Eligibility Criteria

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 = = 9, PSA = = 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 = 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 = = 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 = = 30 mL/min estimated using Cockcroft-Gault equation (within 90 days prior to registration)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = = 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, measure direct and indirect bilirubin, and if direct bilirubin is = 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 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)/ac
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04037254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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