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Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Re-verified, no change to tracked fieldsv10
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 4 to 5
    • Primary completion date changed from estimate of Aug 2022 to Jan 4, 2023
    • Study completion date: Aug 2023 to Aug 2029
    v9
  3. Notable Primary completion date: Aug 2020 to Aug 2022
    • Study completion date: Aug 2021 to Aug 2023
    v8
  4. Minor Study sites: 3 to 4v7
  5. Minor Study sites: 2 to 3v6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Site contacts updated at 1 of 2 sitesv5
  2. Notable Lead sponsor: Vanderbilt-Ingram Cancer Center to Northwestern University
    • Study sites: 1 to 2
    v4
  3. Notable Primary completion date: Aug 2018 to Aug 2020
    • Study completion date: Aug 2019 to Aug 2021
    • Eligibility criteria shortened, about 222 words
    • Study description expanded, about 11 words
    v3
  4. Notable Phase: Not applicable to Phase 4
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2017 to Mar 31, 2017
    • Site details revised
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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This clinical trial studies cognitive function in men with prostate cancer treated with androgen receptor directed therapies such as abiraterone acetate and enzalutamide. The investigators use MRI imaging (non-invasive, non-contrast) to see whether there are changes in brain structure or activity related to treatment that may be related to changes in cognitive function. The investigators are also looking for genetic variations that might make patients more or less sensitive to cognitive changes during treatment for prostate cancer.
Trial Details
NCT Number NCT03016741
Lead Sponsor Northwestern University
Conditions
(from sponsor)
Castration-Resistant Prostatic Cancer, Metastatic Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer, Hormone-Refractory Prostate Cancer
Related terms Cognitive Dysfunction, Dementia, Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov