Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06173362

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

Led by University of California, Davis · Updated on 2026-03-13

75

Participants Needed

1

Research Sites

181 weeks

Total Duration

On this page

Sponsors

U

University of California, Davis

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willing to sign informed consent
  • Histologically confirmed prostate adenocarcinoma
  • Advanced prostate cancer appropriate for abiraterone acetate plus prednisone or darolutamide treatment
  • Encouraged to be currently treated with androgen deprivation therapy or have had bilateral orchiectomy
  • Performance status 0 to 2 (Karnofsky score 50% or higher)
  • Age 18 years or older at time of consent
  • Life expectancy of 6 months or more
  • Ability and willingness to follow study visit schedule and protocol requirements
Not Eligible

You will not qualify if you...

  • Have been on abiraterone or darolutamide for more than 28 days before enrollment
  • Any condition that would prevent understanding or giving informed consent or interfere with safety or compliance in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

Actively Recruiting

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Research Team

O

OCR Referral Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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