Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
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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