NCT06173362RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 7 Dec 2023
- Start date
- 9 Nov 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- University of California, Davis
- Diseases
- Prostate cancer
- NCT number
- NCT06173362
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 75
- From 9 Nov 2023 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have been on either abiraterone or darolutamide for \> 28 days prior to initiating enrollment
Other illness
- 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
Who the study is looking for
- 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 ≥ 50%)
- Age ≥ 18 years at time of consent
- Life expectancy ≥ 6 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.