CClinicalTrials.gg
CompletedNCT05764005Updated Mar 6, 2026Results posted

Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study

An interventional study of web-based tool (MAP- Management of Active surveillance in Prostate Cancer) and MUSIC website in Prostate Cancer, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to male participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by University of Michigan Rogel Cancer Center · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
55 Years and older
Sex
Male
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Study summary

This is a pilot evaluation of a patient-centered intervention that enables providers to support men on active surveillance to maximize adherence. Conducted in urology practices, this pilot will measure key patient-reported, provider-reported, and implementation outcomes. Successful completion of this work will inform a subsequent multi-center effectiveness-implementation hybrid design trial and ultimately will improve low-risk cancer management by effectively engaging Primary Care Physicians (PCPs) in care delivery.

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Conditions studied

  • Prostate Cancer

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Keywords

  • low-risk
  • active surveillance
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In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 39 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Patient Inclusion Criteria:

  • 55 years old or older
  • Men diagnosed with low-risk prostate cancer currently on active surveillance
  • Men who identify having a primary care provider
  • Access and ability to use the Internet

Patient Exclusion Criteria:

  • Men who are unable to read and/or speak English
  • Men with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss)

PCP Inclusion Criteria:

  • Identified by patient on baseline survey as their PCP

Urologist and Clinic Staff Inclusion Criteria:

  • Clinicians or staff at a participating urology clinic, including but not limited to MDs, APPs, and nurses
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Intervention website

    Behavioral: web-based tool (MAP- Management of Active surveillance in Prostate Cancer)

  • Active comparator
    Control MUSIC website

    This is usual care and all urologists are encouraged to refer their patients to the patient educational materials on the MUSIC website (http://www.musicurology.com/patientmaterials/).

    Behavioral: MUSIC website

Interventions

  • Behavioralweb-based tool (MAP- Management of Active surveillance in Prostate Cancer)

    A web-based tool with modules on active surveillance education, team based active surveillance care delivery and the role of the PCP, and self-management for cancer anxiety and worry. {may need more detail}

  • BehavioralMUSIC website

    Standard of care educational materials {add more detail}

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What researchers measure

Primary outcomes

  1. Feasibility - Recruitment

    Defined as the successful recruitment of 40 patients.

    Time frame: up to 9 months

  2. Feasibility - Uptake

    Defined as the proportion of men who complete the baseline and follow-up surveys out of the total number of patients recruited.

    Time frame: up to 6 months

  3. Acceptability - Mean Satisfaction Scores

    Acceptability asks the extent to which participants consider the intervention is agreeable. Patients in the intervention arm will answer questions (on a 5-point Likert scale) regarding the use of the tool including: a) the tool provided me the necessary information about being on active surveillance; b) the tool helped me know what tests I needed and when; c) the tool helped me understand what my PCP can do for my active surveillance; d) the tool was easy to use; e) the amount of time it took to go through the website; and f) I would recommend the tool to other patients. We will ask an open-ended question on if the tool should have any other features in future versions. We will additionally collect paradata such as user actions (clicks) and time spent on each webpage. Mean score will be provided from a scale of 1-5 for each question. 5 indicating greater acceptability. The name of the web-based tool being studied is MAP- Management of Active surveillance in Prostate Cancer.

    Time frame: up to 4 months

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Results

Posted Mar 6, 2026

Participant flow

Participant flow — Overall Study
MilestoneIntervention WebsiteControl MUSIC Website
Started1718
Completed1718
Not completed00

Outcome measures

PrimaryFeasibility - Recruitment

Defined as the successful recruitment of 40 patients.

Time frame:
up to 9 months
Reported as:
Count of participants · Participants
Feasibility - Recruitment
ParticipantsTotal Study Enrollment
Feasibility - Recruitment39
PrimaryFeasibility - Uptake

Defined as the proportion of men who complete the baseline and follow-up surveys out of the total number of patients recruited.

Time frame:
up to 6 months
Reported as:
Count of participants · Participants
Feasibility - Uptake
ParticipantsTotal Study Enrollment
Feasibility - Uptake30
PrimaryAcceptability - Mean Satisfaction Scores

Acceptability asks the extent to which participants consider the intervention is agreeable. Patients in the intervention arm will answer questions (on a 5-point Likert scale) regarding the use of the tool including: a) the tool provided me the necessary information about being on active surveillance; b) the tool helped me know what tests I needed and when; c) the tool helped me understand what my PCP can do for my active surveillance; d) the tool was easy to use; e) the amount of time it took to go through the website; and f) I would recommend the tool to other patients. We will ask an open-ended question on if the tool should have any other features in future versions. We will additionally collect paradata such as user actions (clicks) and time spent on each webpage. Mean score will be provided from a scale of 1-5 for each question. 5 indicating greater acceptability. The name of the web-based tool being studied is MAP- Management of Active surveillance in Prostate Cancer.

Time frame:
up to 4 months
Reported as:
Mean · score on a scale
Acceptability - Mean Satisfaction Scores
score on a scaleIntervention WebsiteControl MUSIC Website
Acceptability- Total3.53 ± 0.83—
MAP Satisfaction 1 - I would recommend the MAP program to other people3.70 ± 0.95—
MAP Satisfaction 2- Using the MAP program helped me learn about active surveillance.3.30 ± 1.34—
MAP Satisfaction 3- The MAP program helped me know what tests I needed and when.2.80 ± 1.32—
MAP Satisfaction 5- The program helped me understand what my PCP can do for my active surveillance.3.40 ± 1.35—
MAP Satisfaction 8- The MAP program took too much time.4.40 ± 0.70—
MAP Satisfaction 12- The MAP program was easy to use.3.60 ± 1.17—

Adverse events

Collected over Patients were monitored while on study for an average of 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Website0/17 (0%)0/17 (0%)0/17 (0%)
Control MUSIC Website0/18 (0%)0/18 (0%)0/18 (0%)

Baseline characteristics

Age, Customized
Age, Customized(years)Intervention WebsiteControl MUSIC WebsiteTotal
Mean69.3 ± 6.168.2 ± 7.968.7 ± 7.0
Sex: Female, Male
Sex: Female, Male(Participants)Intervention WebsiteControl MUSIC WebsiteTotal
Female000
Male171835
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Intervention WebsiteControl MUSIC WebsiteTotal
Hispanic or Latino101
Not Hispanic or Latino161834
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention WebsiteControl MUSIC WebsiteTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American011
White161733
More than one race000
Unknown or Not Reported101
Region of Enrollment
Region of Enrollment(participants)Intervention WebsiteControl MUSIC WebsiteTotal
United States171835
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Study locations

1 site
  • University of Michigan Rogel Cancer Center
    Ann Arbor, Michigan 48109, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 7, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05764005
Lead sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 10, 2023
Start date
Nov 9, 2022
Primary completion
Mar 11, 2024
Completion
Mar 11, 2024
Results posted
Mar 6, 2026
Last update
Mar 6, 2026

Study contacts

Archana Radhakrishnan
principal investigator · University of Michigan Rogel Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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