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Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer
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.
Details
| Lead sponsor | Northwestern University |
|---|---|
| Phase | Phase 4 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 100 |
| Start date | 2017-03-31 |
| Completion | 2029-08 |
Conditions
- Castration-Resistant Prostatic Cancer
- Metastatic Prostate Carcinoma
- Recurrent Prostate Carcinoma
- Stage IV Prostate Cancer
- Hormone-Refractory Prostate Cancer
Interventions
- GnRH agonist/antagonist
- Prednisone
- Abiraterone Acetate
- Enzalutamide
Primary outcomes
- Cognitive function defined by overall Cogstate score and Cogstate module scores for each domain — Measured at baseline, 3 months, 6 months, and 12 months
Raw scores on each module of the Cogstate test will be converted to standardized scores (z-scores and T-scores) according to age and/or education-adjusted published normative data per the Cogstate protocol. Linear regressions will be utilized to assess the mean differences between groups at each time point after the baseline while adjusting for baseline scores.
Countries
United States