Study on Niraparib, Abiraterone Acetate, and Prednisone for Metastatic Hormone-Sensitive Prostate Cancer with Specific Genetic Changes

Sponsor: Qian Qin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06392841

This clinical trial is testing a combination of medications, including Niraparib, Abiraterone Acetate, and Prednisone, to treat men with metastatic hormone-sensitive prostate cancer that has specific genetic changes affecting DNA repair.

Patient Parameters

Program Overview

This study is open to men with metastatic hormone-sensitive prostate cancer (mHSPC) who have not received prior treatment for their cancer and have specific genetic changes that affect DNA repair. These changes include alterations in genes like BRCA1/2 and others. The trial will enroll 64 participants to evaluate the effectiveness of the drug combination in controlling cancer growth.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and agree to share personal health information.
  • Must be 18 years or older.
  • Identify as Hispanic/Latino or non-Hispanic Black.
  • Have a performance status that allows for daily activities with some limitations.
  • Have a confirmed diagnosis of prostate cancer.
  • Have specific genetic changes in DNA repair genes, confirmed by tests.
  • Have evidence of cancer spread to other parts of the body.
  • Have not received extensive prior treatment for prostate cancer.
  • Have adequate organ function based on blood tests.
  • Men able to father a child must agree to use contraception.
  • Must be able to swallow tablets.
  • Have a life expectancy of at least 12 months.
  • Must understand and agree to follow study procedures.

Exclusion Criteria

  • Have prostate cancer with neuroendocrine or small cell features.
  • Have received certain prior treatments for prostate cancer.
  • Have had recent radiation therapy.
  • Have severe allergies to study medications.
  • Have medical conditions that prevent the use of prednisone.
  • Require long-term use of high-dose steroids.
  • Have had major surgery recently.
  • Have brain metastases causing symptoms.
  • Have active liver disease or severe liver impairment.
  • Have a history of certain blood disorders.
  • Have recent severe heart problems.
  • Have uncontrolled high blood pressure.
  • Have HIV with certain conditions.
  • Have active infections requiring treatment.
  • Have other active cancers needing treatment.
  • Have participated in another clinical trial recently.

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