Status:
RECRUITING
Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer
Lead Sponsor:
Mamta Parikh
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Advanced Prostate Adenocarcinoma
Stage III Prostate Cancer AJCC v8
Eligibility:
MALE
18+ years
Phase:
PHASE2
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...
Detailed Description
PRIMARY OBJECTIVE: I. Tolerability. SECONDARY OBJECTIVES: I. Tolerability in prespecified subpopulations. II. Prostate-specific antigen (PSA) response at 7 months. OUTLINE: Patients are assigned ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06173362
Start Date
November 9 2023
End Date
May 1 2027
Last Update
December 18 2024
Active Locations (1)
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1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817