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

Recruiting now · Phase 2

Conditions studied: Advanced Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT06173362

Run by

University of California, Davis

People needed

75

Starts

2023-11-09

Expected to finish

2027-05-01

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Have been on either abiraterone or darolutamide for > 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

Where it is running

• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)

Full record on ClinicalTrials.gov

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