Clinical trial NCT04852224: Strength, Aging, and Memory in Prostate Cancer
Official title: Strength, Aging, and Memory in Prostate Cancer: A Prospective Study of the Effects of Androgen Deprivation on Neurocognition and Frailty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Neoplasm
Prostate Cancer
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: American College of Sports Medicine
First posted: 2021-04-21
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men aged 19 years and older diagnosed with prostate cancer either under active surveillance or scheduled to receive/within 30 days of receiving androgen deprivation therapy; and age-matched men without a history of cancer.

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.

Eligibility criteria: Inclusion Criteria:

* 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-)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in inhibitory control
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in cognitive flexibility
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in executive function
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in spatial working memory reaction time
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in short term memory
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in processing speed
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in verbal memory
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in visuospatial function
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in white matter integrity
timeFrame: Baseline (M0), 6-month follow-up (M6)
measure: Change in brain volume
timeFrame: Baseline (M0), 6-month follow-up (M6)
measure: Change in resting state functional connectivity
timeFrame: Baseline (M0), 6-month follow-up (M6)
measure: Change in self-reported cognitive function
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Secondary outcomes:
measure: Change in appendicular lean mass index
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in physical function
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in functional capacity
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in upper body strength
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in lower body strength
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in physical activity
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
measure: Change in cancer-related fatigue
timeFrame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Diane Ehlers, PhD
role: STUDY_DIRECTOR
References: