Strength, Aging, and Memory in Prostate Cancer

Prostate Cancer Clinical Trial

— STAMP  

Official title:

Strength, Aging, and Memory in Prostate Cancer: A Prospective Study of the Effects of Androgen Deprivation on Neurocognition and Frailty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852224
• Other study ID #: 0261-21-FB
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: April 26, 2023

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 26, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Drug:
• Androgen deprivation therapy
Prostate cancer survivors in the ADT+ group will have been prescribed androgen deprivation therapy for a period of 6-months or more by their treating oncologist prior to consent for this study.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	American College of Sports Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inhibitory control	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.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Primary	Change in cognitive flexibility	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.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Primary	Change in executive function	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.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Primary	Change in spatial working memory reaction time	Change in reaction time on spatial working memory task, with faster reaction times indicating better spatial working memory.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Primary	Change in short term memory	Change in accuracy on N-Back task, with higher accuracy indicating better short-term memory.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Primary	Change in processing speed	Change in accuracy on Attentional Blink task, with higher accuracy indicating faster processing speed.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Primary	Change in verbal memory	Change in number recalled on Hopkins Verbal Learning Task, with greater number of items recalled indicating better verbal memory.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Primary	Change in visuospatial function	Change in accuracy on Benton Judgement of Line Orientation task, with higher accuracy indicating better visuospatial function.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Primary	Change in white matter integrity	Change in fractional anisotropy as measured by diffusion MRI.	Baseline (M0), 6-month follow-up (M6)
Primary	Change in brain volume	Change in mean cortical thickness of brain regions of interest as measured by an anatomical MRI brain scan.	Baseline (M0), 6-month follow-up (M6)
Primary	Change in resting state functional connectivity	Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence.	Baseline (M0), 6-month follow-up (M6)
Primary	Change in self-reported cognitive function	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.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Secondary	Change in appendicular lean mass index	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.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Secondary	Change in physical function	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.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Secondary	Change in functional capacity	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.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Secondary	Change in upper body strength	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.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Secondary	Change in lower body strength	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.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Secondary	Change in physical activity	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.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Secondary	Change in cancer-related fatigue	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.	Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)