230
Participants
Start Date
August 31, 2006
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
Questionaires
We will use a 6-month longitudinal design to assess the short-term cognitive effects of androgen ablation therapy. We will collect 6-month longitudinal data on 170 men with prostate cancer. All 170 men will be hormone naïve at the start of this study (Hormone Naïve Group). These 170 men will consist of two subgroups. The first subgroup will comprise 70 men with prostate cancer age 65 and older scheduled to start androgen ablation therapy. Their cognitive functioning will be assessed prior to starting androgen ablation therapy or within 21 days after initiation, (i.e. baseline) and then 6 months later (Androgen Ablation Subgroup).The second subgroup will serve as a control group, and consist of 100 men with prostate cancer age 65 and older who are at least 1-year post definitive localized treatment with no evidence of disease and no plan to start androgen ablation therapy (No Androgen Ablation Subgroup).
Questionaires
To supplement the pilot data collected in Aim 1, Aim 2 we will utilize a group comparison design to assess the long-term cognitive effects of androgen ablation therapy. We will collect data on the cognitive functioning of 110 men with prostate cancer age 65 and older who have been on continuous androgen ablation therapy for 1-3 years (2-Year Androgen Ablation Group). These men will complete the study battery once (i.e., the neuropsychological battery, psychosocial questionnaires, and a functional status battery). We will compare the cognitive functioning of these 110 men in the 2-Year Androgen Ablation Group to the 170 men with prostate cancer who are hormone naïve (Hormone Naïve Group).
fMRI scan (optional)
Main study participants will be offered to complete an optional fMRI. Fifteen participants from the No Androgen Ablation Subgroup and 15 participants from the Comparison Androgen Ablation Subgroup or Longitudinal Androgen Ablation Subgroup will be recruited for this portion of the study. The fMRI will be scheduled either the same day as the neurocognitive assessment or within eight weeks of the neurocognitive testing. The fMRI will be performed only once at baseline for the Comparison Androgen Ablation Subgroup. The fMRI will be performed at the follow-up time point for the Longitudinal Androgen Ablation Subgroup. The fMRI will be performed at baseline for the No Androgen Ablation Subgroup; if the fMRI can not be completed at baseline (due to participant schedule conflict, lack of fMRI availability, staff schedule conflict, etc.), then the scan will be conducted at the follow-up time point if possible.
Memorial Sloan Kettering Cancer Center, New York
City of Hope, Duarte
National Cancer Institute (NCI)
NIH
City of Hope National Medical Center
OTHER
Fordham University
OTHER
Columbia University
OTHER
NYU Langone Health
OTHER
Weill Medical College of Cornell University
OTHER
Memorial Sloan Kettering Cancer Center
OTHER