Prostate NeoplasmSTAMPNCT04852224
Strength, Aging, and Memory in Prostate Cancer
An observational study of Prostate Neoplasm and Prostate Cancer, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Neoplasm, Prostate Cancer
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 26 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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-)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Oct 2021
- Primary completion11 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Sports Medicine
- Responsible party
- Sponsor
- Investigators
- Diane Ehlers, PhD, Study director, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852224
- Sponsor's protocol ID
- 0261-21-FB
- Acronym
- STAMP
- Status last verified
- Sep 2024
- First submitted
- 15 Apr 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength, Aging, and Memory in Prostate Cancer: A Prospective Study of the Effects of Androgen Deprivation on Neurocognition and Frailty
- ClinicalTrials.gov ID
- NCT04852224
- Acronym / sponsor ID
- STAMP / 0261-21-FB
- Conditions
- Prostate Neoplasm, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- American College of Sports Medicine
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Telephone Interview of Cognitive Status (TICS-M) performance above impaired range (≥21)
- 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-)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Change in white matter integrity
Time frame: Baseline (M0), 6-month follow-up (M6)
Change in fractional anisotropy as measured by diffusion MRI.
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.
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.
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.
7 secondary outcomes
Change in appendicular lean mass index
Time frame: 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)
Change in functional capacity
Time frame: 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 lower body strength
Time frame: 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 cancer-related fatigue
Time frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Ehlers, PhD study director
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Neoplasm and Prostate Cancer, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inhibitory control (time frame: Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.