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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Survivorship and Cognitive Health (PRO-HEALTH)
- ClinicalTrials.gov ID
- NCT05540782
- Acronym / sponsor ID
- 22-223
- Conditions
- Prostate Cancer, Survivorship
- Keywords
- Cognitive health, Quality of Life, 22-223
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 8 Sep 2027 (estimated)
- Study completion
- 8 Sep 2027 (estimated)
- First posted
- 15 Sep 2022 (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 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivors of Prostate Cancer | – | Behavioral: PROMIS-SF v2.0 -Cognitive Function 8aThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- 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.
Key inclusion criteria (4 listed)
- English-speaking
- Age 18 years or older
- History of histologically documented PC of any stage
- No evidence of PC Disease
Key exclusion criteria (3 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROMIS-SF v2.0 -Cognitive Function 8aPatient-Reported Outcomes (PROs) | Behavioural | Survivors of Prostate Cancer |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
Kevin Liou principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Survivorship, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
number of participants with co-morbid symptoms (time frame: 1 year). 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 14 Oct 2026.