NCT06173362 Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer
| NCT ID | NCT06173362 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Davis |
| Condition | Advanced Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-11-09 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2023-11-09 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Mamta Parikh
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT06173362 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Advanced Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06173362 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06173362 currently recruiting?
Yes, NCT06173362 is actively recruiting participants. Contact the research team at OCRReferral@health.ucdavis.edu for enrollment information.
Where is the NCT06173362 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT06173362 clinical trial?
NCT06173362 is sponsored by University of California, Davis. The principal investigator is Mamta Parikh at University of California, Davis. The trial plans to enroll 75 participants.