Strength, Aging, and Memory in Prostate Cancer
- Conditions
- Prostate NeoplasmProstate Cancer
- Interventions
- Drug: Androgen deprivation therapy
- Registration Number
- NCT04852224
- Lead Sponsor
- University of Nebraska
- Brief Summary
The objective of this study is to compare changes in neurocognitive function across a 12-month period between three groups: (1) men treated with androgen deprivation therapy (ADT) for prostate cancer (PCa); (2) men under active surveillance for PCa; and (3) men without a history of cancer.
- Detailed Description
Aim 1: This study will examine differences in neurocognitive function (cognitive performance, brain structural integrity) from baseline (within 30 days of ADT initiation or 90 days of diagnosis) to 6- and 12-month follow-up.
Aim 2: Examine group differences in components of frailty (e.g., lean mass, muscle strength, physical function, fatigue, physical activity) from baseline to 6- and 12-month follow-up.
Men will be recruited for this study if they are (1) recently diagnosed with PCa and scheduled to receive 6-months or more of ADT (ADT+ group, n=20), (2) recently diagnosed with PCa and under active surveillance (ADT- group, n=20), or (3) healthy men without a history of cancer (PCa- group, n=20). Eligible men (N=60) will be scheduled for two or three testing appointments at each testing timepoint. To assess Aim 1, participants will complete measures at baseline (M0), 6-month follow-up (M6), and 12-month follow-up (M12). Aim 1 measures include: neurocognitive tasks, functional magnetic resonance imaging (optional; n=10 ADT+ and n=10 ADT- only), and questionnaires. To assess Aim 2, outcomes indicated as components of frailty syndrome will be measured, including: dual-energy X-ray absorptiometry (e.g., appendicular lean mass), upper and lower body dynamometry, physical function and functional capacity, questionnaires (i.e., fatigue surveys), and physical activity monitoring (i.e., accelerometry). Findings from this study will build upon the scientific framework for the potential frailty pathway of cancer-associated cognitive decline in PCa patients in order to develop future evidence-based interventions to manage cognitive impairment in men diagnosed with PCa.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
- Telephone Interview of Cognitive Status (TICS-M) performance above impaired range (≥21)
Group-specific criteria:
- First time, primary diagnosis of prostate cancer (ADT+ and ADT-)
- Diagnosed within past 30 days (ADT-)
- Scheduled to receive ≥ 6-months androgen deprivation therapy and have not received >30 days of androgen deprivation therapy (ADT+)
- Men without a history of cancer who are within one year of age of ADT+ participants (PCa-)
- Second cancer diagnosis (excluding non-invasive skin cancers)
- History of stroke, transient ischemic attack, neurological disorder, or brain surgery involving tissue removal
- Unable to walk without assistance
- Unwilling to complete study requirements
- Body weight greater than 300 pounds (DXA requirement)
- Moderate-intensity physical activity ≥ 150 minutes per week
- Upper and lower body strength training ≥ 2 days per week
- Unable to read in English
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Androgen Deprivation Therapy (ADT+) Androgen deprivation therapy Men diagnosed with prostate cancer and scheduled to receive greater than or equal to 6-months of treatment with androgen deprivation therapy
- Primary Outcome Measures
Name Time Method Change in executive function Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in completion time on Trails B task, with higher values indicating lower executive function. Trails B completion time is a continuous variable with no minimum or maximum value.
Change in visuospatial function Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in accuracy on Benton Judgement of Line Orientation task, with higher accuracy indicating better visuospatial function.
Change in white matter integrity Baseline (M0), 6-month follow-up (M6) Change in fractional anisotropy as measured by diffusion MRI.
Change in brain volume Baseline (M0), 6-month follow-up (M6) Change in mean cortical thickness of brain regions of interest as measured by an anatomical MRI brain scan.
Change in resting state functional connectivity Baseline (M0), 6-month follow-up (M6) Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence.
Change in self-reported cognitive function Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) The perceived cognitive impairments subscale of the Functional Assessment in Cancer Therapy - Cognition (FACT-Cog) will be sued to measure self-reported cognition. Scores range from 0-72, with higher scores indicating better cognitive function.
Change in cognitive flexibility Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in reaction time on Task-switch task, with higher values indicating lower cognitive flexibility. The Task-switch reaction time is a continuous variable with no minimum or maximum value.
Change in inhibitory control Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in interference score on Stroop task, with negative values indicating lower inhibitory control. The Stroop task interference score is a continuous variable with no minimum or maximum value.
Change in spatial working memory reaction time Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in reaction time on spatial working memory task, with faster reaction times indicating better spatial working memory.
Change in verbal memory Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in number recalled on Hopkins Verbal Learning Task, with greater number of items recalled indicating better verbal memory.
Change in short term memory Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in accuracy on N-Back task, with higher accuracy indicating better short-term memory.
Change in processing speed Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in accuracy on Attentional Blink task, with higher accuracy indicating faster processing speed.
- Secondary Outcome Measures
Name Time Method Change in appendicular lean mass index Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in appendicular lean mass index (ALMI) as measured by dual-energy X-ray absorptiometry (DXA) with higher scores indicating more lean mass. Appendicular lean mass, as measured by DXA, will be divided by height to determine ALMI. ALMI score is a continuous variable with no minimum or maximum value.
Change in physical function Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) The Short Physical Performance Battery (SPPB) will be used to assess physical function. Higher scores on the SPPB are indicative of better physical function. The SPPB has a minimum score of 0 and a maximum score of 12.
Change in functional capacity Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) The Six Minute Walk Test (6MWT) will be used to measure functional capacity. The 6MWT is scored as distance walked in the 6 minutes with greater distance indicating greater functional capacity.
Change in upper body strength Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in grip strength as measured by hand grip dynamometry with higher scores indicating greater upper body strength. Hand grip strength is a continuous variable with no minimum or maximum value.
Change in lower body strength Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in quadriceps strength as measured by hand-held quadriceps dynamometry with higher scores indicating greater lower body strength. Quadriceps strength is a continuous variable with no minimum or maximum value.
Change in physical activity Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) Change in daily minutes of moderate to vigorous physical activity (MVPA) will be measured via accelerometry with more minutes of daily MVPA indicating more physical activity.
Change in cancer-related fatigue Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) The Functional Assessment in Chronic Illness Therapy (FACIT) - Fatigue Scale will be used to measure cancer-related fatigue. Scores range from 0-52, with higher scores indicating less cancer-related fatigue.
Trial Locations
- Locations (1)
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States