Strength, Aging, and Memory in Prostate Cancer (STAMP)

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Prostate Neoplasm
• Intervention / Treatment: Drug: Androgen deprivation therapy

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.; Other Names: Leuprolide; Goserelin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: American College of Sports Medicine
• Investigators: Study Director: Diane Ehlers, PhD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide; Goserelin; Androgens
• Other Study ID Numbers: 0261-21-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The final dataset will not include identifying information; however, there is still a possibility of deductive disclosure of identity. Therefore, data will not be a shared via an NIH or approved public repository. We will share de-identified as required for publication in scientific journals and with outside collaborators and scientists upon request.
• IPD Sharing Time Frame: Data will be shared via scientific journals at the time of publication and with outside collaborators before publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No