Recruiting

Decision Aid

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06785441

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 65+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This protocol describes pilot testing of an educational shared decision-making intervention to help men with localized prostate cancer 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

NCT06785441

Start date

May 25, 2023

Status verified date

Jan, 2025

Completion date

Feb 2, 2030

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients:

1. Males aged 65 or older
2. Diagnosis of localized prostate cancer
3. Have not received curative intent treatment for their prostate cancer
4. Fluent in English

Care partners/caregivers:

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:

Patients

1. Currently receiving treatment for another cancer (primary or recurrence)

Care partners/caregivers

1. None

Study Design

Enrollment

180 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Preparation for Decision Making Scale [ Time Frame: Through study completion and average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Lisa Lowenstein, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Feb 4, 2025

Last verified

Jan, 2025

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 2025-02-04.