Comparing Abiraterone with Prednisone or Darolutamide for Advanced Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effects of abiraterone combined with prednisone versus darolutamide alone in patients with advanced prostate cancer. The study aims to assess the tolerability of these treatments and their impact on prostate-specific antigen (PSA) levels over a period of one year. Patients will be monitored for side effects and will undergo blood sample collection throughout the study. The trial includes a follow-up period of three years after treatment completion.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting

Study contacts

• Principal investigator: Mamta Parikh — University of California, Davis
• Study coordinator: OCR Referral Team
• Email: OCRReferral@health.ucdavis.edu
• Phone: 916-382-6970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.