Status:
ACTIVE_NOT_RECRUITING
Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide
Lead Sponsor:
Alliance Foundation Trials, LLC.
Collaborating Sponsors:
Bayer
Conditions:
Metastatic Prostate Cancer
Prostate Cancer Metastatic
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is a prospective, randomized, open-label phase II study comparing cognitive outcomes between men with metastatic and non-metastatic castration resistant prostate cancer (CRPC) or metastatic hormo...
Detailed Description
The goal of the trial is to assess cognitive and quality of life outcomes over the 48-week primary data collection period of the trial. This is a prospective, randomized, open-label phase II study com...
Eligibility Criteria
Inclusion
- Key inclusion criteria include:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Progressive disease per PCWG3 criteria with EITHER: Metastatic CRPC or non- metastatic CRPC (M0CRPC)
- For mCRPC: metastatic disease documented by standard or novel imaging techniques
- OR for M0CPRC: no evidence of metastatic disease on standard imaging.
- OR mHSPC
- Surgically or medically castrated, with testosterone levels of \<50 ng/dL. If the patient is medically castrated, continuous dosing with GnRH agonist or antagonist must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Able to complete cognitive testing and patient reported outcome surveys in English.
- Ability to swallow study medications whole.
- Able to provide informed consent.
Exclusion
Key Trial Info
Start Date :
August 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT04335682
Start Date
August 17 2021
End Date
August 1 2026
Last Update
November 4 2025
Active Locations (8)
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1
University of California - San Francisco at Mount Zion
San Francisco, California, United States, 94115
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
3
University of Chicago
Chicago, Illinois, United States, 60637
4
University of Kansas Cancer Center
Fairway, Kansas, United States, 66205