Comparing Abiraterone with Prednisone or Darolutamide for Advanced Prostate Cancer
A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide
This study is testing whether a combination of abiraterone and prednisone works better than darolutamide alone for people with advanced prostate cancer by looking at side effects and changes in PSA levels over a year.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06173362 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 18 and older with histologically confirmed advanced prostate adenocarcinoma who are appropriate for treatment with either abiraterone and prednisone or darolutamide.
Not a fit: Patients who have previously been treated with abiraterone or darolutamide for more than 28 days prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into effective treatment options for advanced prostate cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using androgen deprivation therapies for advanced prostate cancer, making this approach a continuation of established treatment strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Sacramento, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.