Prostate CancerNCT05764005

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

A study testing web-based tool (MAP- Management of Active surveillance in Prostate Cancer) and MUSIC website in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 55 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: web-based tool (MAP- Management of Active surveillance in Prostate Cancer) and MUSIC website
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 9 Nov 2022to 11 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years and older
Men only
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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.

Conditions: Prostate Cancer
Being tested: web-based tool (MAP- Management of Active surveillance in Prostate Cancer), MUSIC website
Keywords: low-risk, active surveillance
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

web-based tool (MAP- Management of Active surveillance in Prostate Cancer)Behavioural
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}
MUSIC websiteBehavioural
Standard of care educational materials {add more detail}

Study groups in NCT05764005
Study group	Role	What they receive
Intervention website	Experimental	Not described Receives: Behavioral: web-based tool (MAP- Management of Active surveillance in Prostate Cancer)
Control MUSIC website	Active comparator	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/). Receives: Behavioral: MUSIC website

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility - Recruitment
Defined as the successful recruitment of 40 patients.
Measured: up to 9 months
Feasibility - Uptake
Defined as the proportion of men who complete the baseline and follow-up surveys out of the total number of patients recruited.
Measured: up to 6 months
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.
Measured: up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 202211 Mar 2024

First posted10 Mar 2023
Study start9 Nov 2022
Primary completion11 Mar 2024
Study completion11 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05764005
Sponsor's protocol ID: UMCC 2022.059
Other IDs: HUM00209599, 5K08CA245237
Status last verified: Feb 2026
First submitted: 28 Feb 2023
Last updated: 6 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
ClinicalTrials.gov ID: NCT05764005
Acronym / sponsor ID: UMCC 2022.059
Conditions: Prostate Cancer
Keywords: low-risk, active surveillance
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: University of Michigan Rogel Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 9 Nov 2022 (actual)
Primary completion: 11 Mar 2024 (actual)
Study completion: 11 Mar 2024 (actual)
First posted: 10 Mar 2023 (actual)
Results: Posted 6 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention website	Experimental	Behavioral: web-based tool (MAP- Management of Active surveillance in Prostate Cancer)
Control MUSIC website	Active comparator	Behavioral: MUSIC websiteThis 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/).

Who may qualify

Ages: 55 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
web-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}	Behavioural	Intervention website
MUSIC websiteStandard of care educational materials {add more detail}	Behavioural	Control MUSIC website

Primary outcome

Feasibility - Recruitment
Time frame: up to 9 months
Defined as the successful recruitment of 40 patients.
Feasibility - Uptake
Time frame: up to 6 months
Defined as the proportion of men who complete the baseline and follow-up surveys out of the total number of patients recruited.
Acceptability - Mean Satisfaction Scores
Time frame: up to 4 months
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.

Results and safety

Results posted to the registry on 6 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Website	17	17
Control MUSIC Website	18	18

Primary outcome: Feasibility - Recruitment

Time frame: up to 9 months. Count of participants. Unit: Participants

Measure	Total Study Enrollment n = 40
Value	39

Primary outcome: Feasibility - Uptake

Time frame: up to 6 months. Count of participants. Unit: Participants

Measure	Total Study Enrollment n = 35
Value	30

Primary outcome: Acceptability - Mean Satisfaction Scores

Time frame: up to 4 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention Website n = 10	Control MUSIC Website n = 0
Acceptability- Total	3.53 (0.83)	–
MAP Satisfaction 1 - I would recommend the MAP program to other people	3.70 (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)	–

Population analysed: Survey was only given to those in the intervention arm

Adverse events

Time frame: Patients were monitored while on study for an average of 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Website	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Control MUSIC Website	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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. This study is not recruiting at the moment.

Archana Radhakrishnan principal investigator

University of Michigan Rogel Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 6 Mar 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?

Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility - Recruitment (time frame: up to 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05764005.

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 6 Mar 2026.