Study on Hormone Therapy With or Without Niraparib After Radiation for Treating High-Risk Localized or Locally Advanced Prostate Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04947254

Provider View

This clinical trial is exploring whether adding the drug niraparib to standard hormone therapy after radiation can help control prostate cancer that is either localized or has spread to nearby areas. The study involves different combinations of hormone therapy drugs to see which is most effective.

Patient Parameters

Program Overview

This study is investigating if adding niraparib to hormone therapy after radiation can better control prostate cancer that hasn't spread far. Hormone therapy, also known as androgen ablation therapy, reduces male hormones that help prostate cancer grow. The study uses two types of hormone therapy: AAP + ADT (abiraterone acetate and prednisone with androgen deprivation therapy) and Apa + ADT (apalutamide with androgen deprivation therapy). Researchers want to see if these treatments, with or without niraparib, can help manage prostate cancer more effectively.

Description

The main goal of this study is to see if adding niraparib to hormone therapy after radiation can improve treatment outcomes for men with prostate cancer. The study will compare two groups: one receiving maximal hormone therapy with niraparib and the other receiving hormone therapy alone. Researchers will look at how well the cancer is controlled and the safety of the treatments.

The study is divided into three parts:

  1. Neoadjuvant Phase (Cycles 1-3): Patients take apalutamide daily and receive hormone therapy chosen by their doctor. This phase lasts for up to 3 cycles, each 28 days long, unless the cancer progresses or side effects become unacceptable.

  2. Radiation Phase (Cycles 4-6): Within 30 days of completing the first phase, patients undergo radiation therapy while continuing apalutamide and hormone therapy. This phase also lasts for up to 3 cycles.

  3. Adjuvant Phase (Cycles 7 and Beyond): Patients with a good response continue with apalutamide and hormone therapy. Those with a less favorable response are randomly assigned to one of two groups:

    • Group A: Continue apalutamide and hormone therapy for up to 12 cycles.
    • Group B: Take abiraterone acetate, prednisone, hormone therapy, and niraparib for up to 12 cycles.

After treatment, patients will have follow-up visits within 14 days, then at 30-90 days, and every 3 months for 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent before any study procedures.
  • Agree to tissue collection for research purposes.
  • Male, aged 18 years or older.
  • Confirmed diagnosis of prostate cancer.
  • High-risk localized or regional prostate cancer, defined by specific medical criteria.
  • Planned for radiation and hormone therapy as treatment.
  • Willing to maintain low testosterone levels through medical or surgical means.
  • ECOG performance status of 0 to 2, indicating good overall health.
  • Adequate organ and bone marrow function based on recent blood tests.
  • Able to swallow pills.
  • Willing to use effective birth control if they have partners who could become pregnant.
  • Willing to comply with study procedures and visits.
  • Must stop medications that lower the seizure threshold at least 4 weeks before starting the study.

Exclusion Criteria

  • Previous systemic treatment for prostate cancer, except recent hormone therapy.
  • Prostate cancer that has spread to distant parts of the body.
  • Previous major surgery or radiation for prostate cancer.
  • Unresolved side effects from past cancer treatments.
  • History of certain blood disorders or other cancers likely to return soon.
  • Active, uncontrolled infections or liver disease.
  • Lung disease not related to cancer.
  • Medical or psychiatric conditions that could interfere with the study.
  • Difficulty swallowing pills or gastrointestinal issues affecting drug absorption.
  • Known allergies to study drugs.
  • Prisoners or those involuntarily detained.
  • Conditions that increase seizure risk.
  • Recent severe heart problems or uncontrolled high blood pressure.
  • Current gastrointestinal disorders affecting absorption.
  • Active infections like HIV or hepatitis.
  • Chronic conditions requiring high-dose steroids.
  • Use of certain medications that interact with study drugs.
  • Moderate to severe liver impairment.
  • Any condition that the investigator believes would prevent participation.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.