RecruitingPhase 2NCT06173362

Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide


Sponsor

University of California, Davis

Enrollment

75 participants

Start Date

Nov 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial compares the effects, good and/or bad of abiraterone and prednisone or darolutamide alone in treating patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Androgens (male hormones) can cause the growth of prostate tumor cells. Abiraterone acetate lowers the amount of androgens made by the body. This may help stop the growth of prostate tumor cells that need androgen to grow. Darolutamide blocks the use of androgens by the tumor cells. Prednisone is used to lessen inflammation and lower the body's immune response. Researchers want to compare the side effects of standard of care (SOC) abiraterone and prednisone or darolutamide alone in treating patients with advanced prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how well two hormone-blocking treatments — abiraterone (with prednisone) and darolutamide — work in real-world patients with advanced prostate cancer, to better understand which patients benefit most from each drug. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of advanced prostate cancer - Your doctor has recommended starting abiraterone acetate plus prednisone or darolutamide - You are currently on or eligible for androgen deprivation therapy (ADT — hormone therapy to lower testosterone), or have had surgical castration - You have a reasonable performance status and expected life expectancy of at least 6 months **You may NOT be eligible if...** - You have already been on abiraterone or darolutamide for more than 28 days before enrolling - You have a medical condition that would prevent you from safely participating or giving informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbiraterone

Given abiraterone

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

DRUGDarolutamide

Given darolutamide

DRUGPrednisone

Given prednisone


Locations(1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

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NCT06173362


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