Recruiting

Decision Aid

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05497024

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Interviews

Surveys

Study Details

Brief 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. 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.

Conditions

Prostate Cancer

Study ID

NCT05497024

Start date

Aug 15, 2022

Status verified date

Apr, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 65+

Healthy Volunteers: Not accepted

Patients

Inclusion Criteria:

1. Males aged 65 or older
2. Diagnosis of localized prostate cancer
3. On active surveillance for 12 or more months
4. Fluent in English

Exclusion Criteria:

1\. Receiving treatment for another cancer (primary or recurrence)

Caregivers

Inclusion Criteria:

1. Aged 18 or older
2. Fluent in English
3. Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)

Exclusion Criteria:
4. None

Clinicians

Inclusion Criteria:

1. Aged 18 or older
2. Fluent in English
3. Provides clinical care for patients with prostate cancer (e.g. medical oncologists, urologists, radiation oncologists, nurse practitioners, physician assistants)

Exclusion Criteria:

1\. None

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Surveys

Participants may answer questions that are sensitive in nature.

Interviews

The interview may occur over phone, web conferencing, or in-person.

Interventions

Interviews

Participants will discuss background, such as race, education, and living situation.

Participants will discuss Prostate cancer Participants will discuss feedback on the educational material

Surveys

Participants may answer questions that are sensitive in nature.

Primary outcome measure

  • The Ottawa Acceptability Scale [ Time Frame: through study completion and average of 1 year ]

Central Contacts and Locations

Central contacts

Lisa Lowenstein, MD

713-563-0020deescalatepca@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Lisa Lowenstein, MD

713-563-0020deescalatepca@mdanderson.org

Principal Investigator:

Lisa Lowenstein, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-16.