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