Testing the Addition of Niraparib to Usual Hormone and Radiation Therapy for Prostate Cancer with High Recurrence Risk

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04037254

Provider View

This study is exploring whether adding a new drug, niraparib, to the usual hormone and radiation therapy can help prevent prostate cancer from growing or coming back in patients with a high risk of recurrence.

Patient Parameters

Program Overview

This clinical trial is testing if adding niraparib, a drug that blocks an enzyme called PARP, to the standard treatment of hormone and radiation therapy can help stop prostate cancer from growing or returning. Niraparib works by preventing cancer cells from repairing their DNA, which may cause them to die. The study aims to see if this combination can lower the chances of prostate cancer coming back.

Description

The study has two main parts: Phase I and Phase II.

Phase I:

  • The goal is to find the best dose of niraparib when used with radiation and hormone therapy.
  • Patients will take niraparib daily and receive hormone therapy for 24 months.
  • After 8 weeks, they will also start radiation therapy for about 6-9 weeks.

Phase II:

  • Patients are divided into two groups.
  • Group 1: Receives standard hormone therapy and radiation.
  • Group 2: Receives standard hormone therapy, niraparib, and radiation.
  • The study will compare how well the cancer is controlled in both groups.

After treatment, patients will have follow-up visits every 6 months for 3 years, then once a year for another 3 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-risk prostate cancer based on specific medical criteria.
  • No signs of cancer spread to distant parts of the body.
  • Age 18 or older.
  • Good overall health with a performance status of 0 or 1.
  • Specific blood test results within normal ranges.
  • Men must agree to use effective birth control during and for 3 months after treatment.
  • Must provide informed consent to participate.

Exclusion Criteria

  • PSA level over 150 ng/mL.
  • Evidence of cancer spread to other parts of the body.
  • Previous prostate surgery or certain treatments for prostate cancer.
  • Active cancer within the last 2 years that could affect prostate cancer treatment.
  • Severe health conditions like recent heart problems or uncontrolled infections.
  • Allergies to the study drugs.
  • HIV positive with low CD4 count.
  • History of certain blood disorders or previous treatment with PARP inhibitors.

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