Prostate CancerNCT05540782
A Study of Cognitive Health in Survivors of Prostate Cancer
An observational study of Prostate Cancer and Survivorship, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Survivorship
- What is being tested?
- PROMIS-SF v2.0 -Cognitive Function 8a
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Sep 2022to 8 Sep 2027
- Phase
- Observational
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 18 years and older
- Men only
- Adult, Older adult
Study population: Patients from Memorial Sloan Kettering Cancer Center (MSK) and the Ralph Lauren Center (RLC), an MSK-affiliated Harlem community clinic.
Who may be able to join
- English-speaking
- Age 18 years or older
- History of histologically documented PC of any stage
- No evidence of PC Disease
Who cannot join
- <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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center Suffolk - Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: 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.
- Conditions
- Prostate Cancer, Survivorship
- Being tested
- PROMIS-SF v2.0 -Cognitive Function 8a
- Keywords
- Cognitive health, Quality of Life, 22-223
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMIS-SF v2.0 -Cognitive Function 8aBehavioural
Patient-Reported Outcomes (PROs)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PROMIS-SF v2.0 -Cognitive Function 8a |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with co-morbid symptoms
All participants will be evaluable as long as they have completed the PROMIS-SF v2.0 - Cognitive Function 8a.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start8 Sep 2022
- Primary completion8 Sep 2027 (estimated)
- Study completion8 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Liou, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540782
- Sponsor's protocol ID
- 22-223
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2022
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.