Recruiting
Phase 2

Abiraterone & Darolutamide

Sponsor:

UCLA

Code:

NCT06173362

Conditions

Advanced Prostate Adenocarcinoma

Stage III Prostate Cancer AJCC v8

Stage IV Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Abiraterone

Biospecimen Collection

Darolutamide

Prednisone

Study Details

Brief summary:

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

Advanced Prostate Adenocarcinoma

Stage III Prostate Cancer AJCC v8

Stage IV Prostate Cancer AJCC v8

Study ID

NCT06173362

Start date

Nov 9, 2023

Status verified date

Mar, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (abiraterone, prednisone)

Patients receive abiraterone and prednisone per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.

experimental: Arm II (darolutamide)

Patients receive darolutamide per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.

Interventions

Abiraterone

Given abiraterone

Biospecimen Collection

Undergo collection of blood samples

Darolutamide

Given darolutamide

Prednisone

Given prednisone

Primary outcome measure

  • Incidence of grade 3 or higher adverse events [ Time Frame: At 12 months ]

Central Contacts and Locations

Central contacts

OCR Referral Team

916-382-6970OCRReferral@health.ucdavis.edu

Locations

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Office of Clinical Research

916-382-6970OCRReferral@health.ucdavis.edu

Principal Investigator:

Mamta Parikh

More Information

Sponsor

University of California, Davis

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-03-13.