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

October 9, 2023 updated by: University of Nebraska

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in inhibitory control
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6)
Change in fractional anisotropy as measured by diffusion MRI.
Baseline (M0), 6-month follow-up (M6)
Change in brain volume
Time Frame: Baseline (M0), 6-month follow-up (M6)
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
Time Frame: Baseline (M0), 6-month follow-up (M6)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in appendicular lean mass index
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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
Time Frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American College of Sports Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Diane Ehlers, PhD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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