Strength, Aging, and Memory in Prostate Cancer

NCT04852224 | Completed DMC

• 1 other identifier: 0261-21-FB
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Neoplasm; Prostate Cancer

Outcome Measures

Primary Outcomes (12)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• Change in white matter integrity

  Change in fractional anisotropy as measured by diffusion MRI.

  Baseline (M0), 6-month follow-up (M6)

• 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)

• 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)

• 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 Outcomes (7)

• Change in appendicular lean mass index

  Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)

• Change in physical function

  Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)

• Change in functional capacity

  Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)

• Change in upper body strength

  Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)

• Change in lower body strength

  Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)

Study Arms (3)

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

Prostate Cancer Surveillance (ADT-)

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

Non-cancer Control (PCa-)

Age-matched men without a history of cancer

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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-)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• American College of Sports Medicine: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Diane Ehlers, PhD

  University of Nebraska

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 21, 2021
• Study Start: October 1, 2021
• Primary Completion: April 11, 2023
• Study Completion: April 26, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared via scientific journals at the time of publication and with outside collaborators before publication.
• Access Criteria: We will make data available to researchers who agree to use the data only for research purposes, protect the data using secure computer technologies, and destroy the data after relevant analyses are completed and manuscripts are published.

Locations

US (1)