Strength, Aging, and Memory in Prostate Cancer

NCT ID: NCT04852224

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-04-26

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.

Conditions

Prostate Neoplasm; Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Androgen Deprivation Therapy (ADT+)

Men diagnosed with prostate cancer and scheduled to receive greater than or equal to 6-months of treatment with androgen deprivation therapy

No interventions assigned to this group

Prostate Cancer Surveillance (ADT-)

Men diagnosed with prostate cancer under active surveillance (i.e., not receiving active treatment for prostate cancer)

No interventions assigned to this group

Non-cancer Control (PCa-)

Age-matched men without a history of cancer

No interventions assigned to this group

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

American College of Sports Medicine

OTHER

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diane Ehlers, PhD

Role: STUDY_DIRECTOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0261-21-FB

Identifier Type: -

Identifier Source: org_study_id