Study on Niraparib Before Surgery for Patients with High-Risk Localized Prostate Cancer and DNA Repair Issues

Sponsor: Marc Dall'Era, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04030559

Provider View

This clinical trial is testing how well the drug niraparib works when given before surgery to treat patients with high-risk prostate cancer that hasn't spread and has problems with DNA repair. Niraparib may help stop tumor growth by blocking certain enzymes needed for cell growth.

Patient Parameters

Program Overview

This phase II study is exploring the effectiveness of niraparib, a medication given before surgery, in treating patients with high-risk prostate cancer that is localized and has DNA repair defects. The drug may help stop the growth of cancer cells by blocking enzymes necessary for cell growth. Patients will take niraparib daily for up to three cycles before undergoing standard surgery. After treatment, patients will be monitored regularly for up to five years to track their health and any recurrence of cancer.

Description

The main goal of this study is to see how well niraparib works when given before surgery in patients with high-risk localized prostate cancer that has DNA repair defects. Researchers will look at the stage of the tumor, the presence of cancer in lymph nodes, and the rate of positive surgical margins after surgery.

Another goal is to track the recurrence of cancer over five years in patients with these DNA repair issues after surgery.

Patients will take niraparib by mouth once a day for 28 days, repeating this cycle up to three times unless the disease progresses or side effects become unacceptable. After completing the treatment, patients will have standard surgery. Follow-up visits will occur 30 days after treatment, every three months for two years, and then every six months for up to three years.

Eligibility Criteria

Inclusion Criteria

  • Understand and agree to sign an informed consent form.
  • Able to follow the study schedule and requirements.
  • Have confirmed localized prostate cancer classified as high or very high risk.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Life expectancy of at least 10 years.
  • Chosen surgery as the primary treatment for prostate cancer.
  • Prostate cancer with specific DNA repair gene alterations, including BRCA1/2, ATM, and others.
  • Able to swallow whole capsules.
  • Agree to use a condom or practice abstinence during the study and for three months after the last dose.
  • Meet specific blood count and organ function criteria within 14 days before starting treatment.

Exclusion Criteria

  • Unable to understand or sign informed consent.
  • Previous treatment for prostate cancer.
  • Previous treatment with a PARP inhibitor or certain hormone therapies.
  • Any condition or treatment that might interfere with the study results or patient safety.
  • Severe infection within four weeks before joining the study.
  • Allergies or intolerance to niraparib.
  • Disorders affecting absorption in the stomach or intestines.
  • Certain heart conditions or medications that affect heart rhythm.
  • HIV positive with specific conditions, such as not on stable antiretroviral therapy or low CD4 count.

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