Prostate CancerNCT05497024
Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Cognitive and Usability Testing
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This protocol describes development and user testing of an educational shared decision making intervention to help men with prostate cancer who are on active surveillance make decisions with their health care providers about if and when to de-escalate surveillance testing. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Interviews and Surveys
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 2 Feb 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 65 years and older
- Men only
- No healthy volunteers
- Older adult
Study population: M D Anderson Cancer Center
Who may be able to join
- Males aged 65 or older
- Diagnosis of localized prostate cancer
- On active surveillance for 12 or more months
- Fluent in English
- Aged 18 or older
- Fluent in English
Show all 10Show fewer
- Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)
- Aged 18 or older
- Fluent in English
- Provides clinical care for patients with prostate cancer (e.g. medical oncologists, urologists, radiation oncologists, nurse practitioners, physician assistants)
Who cannot join
- 1. Receiving treatment for another cancer (primary or recurrence)
- Caregivers
- None
- Clinicians
- 1. None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Lisa Lowenstein, MD, 713-563-0020, deescalatepca@mdanderson.org
Lisa Lowenstein, MD
About this study
This protocol describes development and user testing of an educational shared decision making intervention to help men with prostate cancer who are on active surveillance make decisions with their health care providers about if and when to de-escalate surveillance testing. The project is important because for many patients their cancer does not progress to the point of needed curative treatment or their health status changes such that they are no longer good candidates for treatment. For these men, de-escalating ongoing surveillance (e.g., fewer biopsies or imaging studies) is a reasonable option.
Read the detailed description
Objectives:
The overall goal of this protocol is to develop and refine an educational tool for use by patients and health-care providers to help men with localized prostate cancer make informed decisions about discontinuation of active surveillance.
- Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with patients
- Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with care partners/caregivers
- Conduct expert reviews of a prototype decision aid with clinicians
- Conditions
- Prostate Cancer
- Being tested
- Interviews, Surveys
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsBehavioural
Participants will discuss background, such as race, education, and living situation.
Participants will discuss Prostate cancer Participants will discuss feedback on the educational material
SurveysBehavioural
Participants may answer questions that are sensitive in nature.
| Study group | Role | What they receive |
|---|---|---|
| Surveys | Participants may answer questions that are sensitive in nature. Receives: Behavioral: Surveys | |
| Interviews | The interview may occur over phone, web conferencing, or in-person. Receives: Behavioral: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ottawa Acceptability Scale
The Ottawa Acceptability scale includes 10 items to assess participant's rating of the educational material ease of use, clarity of information, length, level of detail provided, ability to hold one's interest, and satisfaction with how the materials prepared them for discussing the decision with their clinician
Score Scale (Strongly agree, Agree, Neither agree nor disagree, Disagree Strongly disagree) and (Not at all, A little, Somewhat, Quite a bit, A great deal)
Measured: through study completion and average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start15 Aug 2022
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 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 M.D. Anderson 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Lisa Lowenstein, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497024
- Sponsor's protocol ID
- 2022-0375
- Other IDs
- NCI-2022-06569
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Cognitive and Usability Testing
- ClinicalTrials.gov ID
- NCT05497024
- Acronym / sponsor ID
- 2022-0375
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 11 Aug 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.
This protocol describes development and user testing of an educational shared decision making intervention to help men with prostate cancer who are on active surveillance make decisions with their health care providers about if and when to de-escalate surveillance testing. The project is important because for many patients their cancer does not progress to the point of needed curative treatment or their health status changes such that they are no longer good candidates for treatment. For these men, de-escalating ongoing surveillance (e.g., fewer biopsies or imaging studies) is a reasonable option.
Detailed description
Objectives:
The overall goal of this protocol is to develop and refine an educational tool for use by patients and health-care providers to help men with localized prostate cancer make informed decisions about discontinuation of active surveillance.
- Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with patients
- Conduct cognitive and initial usability and acceptability testing of a prototype decision aid with care partners/caregivers
- Conduct expert reviews of a prototype decision aid with clinicians
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surveys | – | Behavioral: SurveysParticipants may answer questions that are sensitive in nature. |
| Interviews | – | Behavioral: InterviewsThe interview may occur over phone, web conferencing, or in-person. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- M D Anderson Cancer Center
Key inclusion criteria (10 listed)
- Males aged 65 or older
- Diagnosis of localized prostate cancer
- On active surveillance for 12 or more months
- Fluent in English
- Aged 18 or older
Key exclusion criteria (5 listed)
- 1. Receiving treatment for another cancer (primary or recurrence)
- Caregivers
- None
- Clinicians
- 1. None
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 |
|---|---|---|
| InterviewsParticipants will discuss background, such as race, education, and living situation. Participants will discuss Prostate cancer Participants will discuss feedback on the educational material | Behavioural | Interviews |
| SurveysParticipants may answer questions that are sensitive in nature. | Behavioural | Surveys |
Primary outcome
The Ottawa Acceptability Scale
Time frame: through study completion and average of 1 year
The Ottawa Acceptability scale includes 10 items to assess participant's rating of the educational material ease of use, clarity of information, length, level of detail provided, ability to hold one's interest, and satisfaction with how the materials prepared them for discussing the decision with their clinician Score Scale (Strongly agree, Agree, Neither agree nor disagree, Disagree Strongly disagree) and (Not at all, A little, Somewhat, Quite a bit, A great deal)
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 7 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
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.
Lisa Lowenstein, MD principal investigator
M.D. Anderson Cancer Center
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 Cancer, run by M.D. Anderson Cancer Center 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 10 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 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 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?
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?
Contact Lisa Lowenstein, MD (713-563-0020, deescalatepca@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Ottawa Acceptability Scale (time frame: through study completion and average of 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 7 Oct 2026.