Prostate Cancer Clinical Trial

Strength, Aging, and Memory in Prostate Cancer

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.

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Full 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.

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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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

60

Study ID:

NCT04852224

Recruitment Status:

Active, not recruiting

Sponsor:

University of Nebraska

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There is 1 Location for this study

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University of Nebraska Medical Center
Omaha Nebraska, 68198, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

60

Study ID:

NCT04852224

Recruitment Status:

Active, not recruiting

Sponsor:


University of Nebraska

How clear is this clinincal trial information?

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