COGCaP: An Investigation into the Cognitive Side Effects of Androgen Receptor Targeted Therapies

UroToday (Truckee, CA): Whether androgen deprivation therapy (ADT) affects the cognitive function of men with prostate cancer remains controversial. While some studies have demonstrated that ADT impairs cognitive function, other studies have not found any such association. A recently reported prospective trial published in the Journal of Clinical Oncology in 2015 by Gonzalez and colleagues found that men receiving ADT for prostate cancer had higher rates of impaired cognitive performance than similar age and education-matched controls with prostate cancer not receiving ADT and men without prostate cancer. The study also found a gene that may confer genetic susceptibility to impaired cognitive function in some men with prostate cancer receiving ADT.1

In light of this work, and through witnessing patients’ experiences in clinical practice, our team is performing a study of cognitive function in men treated with medications that decrease testosterone signaling in metastatic castration-resistant prostate cancer (mCRPC).  This trial, titled Cognitive Effects of Androgen Receptor Targeted Therapies for Advanced Prostate Cancer (CogCAP), has been generously supported by funds from the Prostate Cancer Foundation. In this study, 100 men with mCRPC will be randomized to either enzalutamide or abiraterone acetate therapy.  They will then complete cognitive assessments over time to determine whether cognitive function changes, and to compare cognitive effects between groups.  Men will be recruited from Vanderbilt University Medical Center, Northwestern University, and several other sites starting in February 2017. 

In addition to assessing cognitive function over time, the study includes several correlative studies that seek to enrich our understanding of the biologic mechanism of cognitive change in this population.  We will complete genetic testing to identify single nucleotide polymorphisms (SNPs) that may be associated with greater cognition dysfunction during treatment. We are including an array of candidate genes, including genes associated with dementia, such as APOE4, sleep, mood, and drug metabolism, that may affect cognitive outcomes. In addition, a subset of men in the study will also undergo non-invasive brain MRI imaging at baseline and 3 months to look for structural or functional changes that may occur in the brain during treatment. The results of these tests will be compared within each treatment group, as well as between treatment groups. 

This clinical trial will provide prospectively collected data describing the effects of treatment on cognitive function in men with prostate cancer, further characterizing a complication of prostate cancer survivorship that influences men and their families each day. We seek to provide data that allows clinicians to match the right treatment to the right man, personalizing treatment choices by suspected benefits as well as potential complications, and improving the quality of life for prostate cancer survivors and their loved ones.  



Written by: Alicia Morgans, MD, MPH

Biography:

Alicia Morgans, MD, MPH is the Assistant Professor of medicine in the Division of Hematology/Oncology at the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee. She specializes in the treatment of genitourinary malignancies, including cancers of the prostate, bladder and testis (germ cell) and penis. Dr. Morgans’ research focus is on complications of prostate cancer survivorship and treatment decision making in advanced prostate cancer.

Reference:
Gonzalez BD, Jim HS, Booth-Jone M, et al. Course and predictors of cognitive function in patients with prostate cancer receiving androgen-deprivation therapy: A controlled comparison. J Clin Oncol. 2015 June 20; 33 (18): 2021-7.

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