- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05540782
A Study of Cognitive Health in Survivors of Prostate Cancer
October 8, 2025 updated by: Memorial Sloan Kettering Cancer Center
Prostate Cancer Survivorship and Cognitive Health (PRO-HEALTH)
The purpose of this study is to collect information that may help the researchers understand the relationship between prostate cancer survivors' experiences of cancer-related cognitive dysfunction (CRCD) and their other conditions (co-morbid factors), including anxiety, depression, and insomnia.
The researchers will also find out how additional things may contribute to CRCD, including social factors, the characteristics of participants' prostate cancer, and the type of cancer treatment or other medications they received.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
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
-
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center Suffolk - Commack
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients from Memorial Sloan Kettering Cancer Center (MSK) and the Ralph Lauren Center (RLC), an MSK-affiliated Harlem community clinic.
Description
Inclusion Criteria:
- English-speaking
- Age 18 years or older
- History of histologically documented PC of any stage
- No evidence of PC Disease
Exclusion Criteria:
- <1 month since completion of surgery, radiation, chemotherapy, or ADT
- Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder
- Score >10 indicative of dementia on Blessed Orientation Memory Concentration
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Survivors of Prostate Cancer
This is a cross-sectional study with a one-time data collection process and no subsequent follow-ups.
If patients did not opt out of receiving study-specific text communications, they may also receive text messages with reminders about surveys and/or direct links to REDCap to complete the surveys.
Text-based communications will be delivered using the secure, HIPAA-compliant Mosio texting platform developed for clinical research.
|
Patient-Reported Outcomes (PROs)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of participants with co-morbid symptoms
Time Frame: 1 year
|
All participants will be evaluable as long as they have completed the PROMIS-SF v2.0 - Cognitive Function 8a.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kevin Liou, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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)
September 8, 2022
Primary Completion (Estimated)
September 8, 2026
Study Completion (Estimated)
September 8, 2026
Study Registration Dates
First Submitted
September 9, 2022
First Submitted That Met QC Criteria
September 13, 2022
First Posted (Actual)
September 15, 2022
Study Record Updates
Last Update Posted (Estimated)
October 9, 2025
Last Update Submitted That Met QC Criteria
October 8, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-223
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
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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