Actively Recruiting
A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide
Led by University of California, Davis · Updated on 2026-03-13
75
Participants Needed
1
Research Sites
25 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
Researchers are evaluating the effects and side effects of two treatments, abiraterone with prednisone and darolutamide alone, in men with advanced prostate cancer that has spread beyond the prostate. This phase II trial aims to assess how well patients tolerate these treatments and compares their impact on prostate tumor growth driven by male hormones. The study also looks at prostate-specific antigen (PSA) response over seven months to understand treatment effects better. Participants are assigned to one of two groups based on their doctor's preference. One group receives abiraterone and prednisone following standard care guidelines, and the other group receives darolutamide alone. Treatments continue for up to one year, provided there is no disease progression or unacceptable side effects. Blood samples are collected during screening and throughout the study to monitor patients. After completing treatment, patients are followed for up to three years to observe long-term outcomes. Throughout the study, researchers monitor for serious side effects, particularly those that are grade 3 or higher, at the 12-month mark. Participants' health is regularly assessed, including their ability to continue treatment and adherence to study visits. This careful monitoring helps evaluate the safety and tolerability of these therapies over time.
CONDITIONS
Brief 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 willingness to sign an informed consent form
- Histologically confirmed prostate adenocarcinoma
- Advanced prostate cancer appropriate for treatment with abiraterone acetate plus prednisone or darolutamide as assessed by the treating physician
- Participants are encouraged to be currently treated with androgen deprivation therapy (ADT) or having undergone bilateral orchiectomy
- Performance status 0 - 2 (Karnofsky 250%)
- Age 2518 years at time of consent
- Life expectancy 256 months per investigator discretion
- Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study
You will not qualify if you...
- Have been on either abiraterone or darolutamide for more than 28 days prior to initiating enrollment
- Any condition that in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants receive abiraterone and prednisone or darolutamide as part of their treatment. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Blood samples are collected during this period.
Visits as per standard of care during treatment
Duration - 3 years
After completing treatment, participants are followed up for monitoring and assessment for a total of 3 years.
Follow-up visits as scheduled for up to 3 years
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
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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