ClinicalTrials.gg
RecruitingNCT07126548Updated Sep 25, 2026

A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men

An interventional study of Best Practice and Discussion in Prostate Carcinoma, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Sep 25, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 71 studies in Prostatic Neoplasms by Mayo Clinic — 19 open to participants now, 24 under way, 2 of them phase 3. Prostatic Neoplasms · Mayo Clinic.

Planned enrollment
10th of 54
200 · median 64
Started
2026
with 2 others
No phase
19 of 71
9 open now
Primary completion
2029-09
later than 19 of 23 live
Registered
68th of 71
by date

Among the 71 studies in Prostatic Neoplasms by Mayo Clinic, this one is the 10th largest by planned enrollment of the 54 interventional ones that give a count, is one of 3 that started in 2026, is one of 19 with no phase, reaches primary completion later than 19 of the 23 other live ones, and was the 68th registered.

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

19 of the 71 studies in Prostatic Neoplasms by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:

13 more — sign in →

By country, each count listing its studies:

All 19 open studies →

Where they have run

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: male · no healthy volunteers.

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02

Study summary

This clinical trial tests how well a point of prostate cancer diagnosis (PPCD) virtual reality assistant (ViRA) intervention works in supporting Black men with newly diagnosed prostate cancer. Cancer is the second leading cause of death for African American/Black men, with prostate cancer leading in estimated new cancer cases and second in estimated new cancer deaths. Over 40,000 African American/Black men are diagnosed with prostate cancer annually, with 1 in 6 lifetime probability of developing prostate cancer compared to 1 in 8 probability in White men. The PPCD ViRA provides psycho-oncology support, social determinants of health navigation and emotional support for ethnically diverse African American/Black men newly diagnosed with prostate cancer using artificial intelligence and augmented reality. Using PPCD ViRA may close the prostate cancer care gap for African American/Black men across the cancer continuum and provide emotional, educational, and resource needs of this population when they are visiting a doctor about their prostate health or prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. Evaluate the effectiveness of the PPCD ViRA (i) on the delivery of PPCD support in a clinic setting, at home and community setting; and (ii) in providing social determinants of health (SDOH) navigation, emotional support and psycho-oncology support for African American/Black men (AA/BM) newly diagnosed with prostate cancer (CaP).

II. Assess the effectiveness of the PPCD ViRA in reducing emotional distress and improving other patient reported outcomes (PROs).

III. Using a mixed-method approach, explore the factors that uniquely influence the implementation of the PPCD ViRA in a clinic setting, at home and community setting.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (DELAYED-START INTERVENTION): Patients receive standard care and then receive access to the ViRA application (app) (on a [virtual reality] VR headset, smartphone, iPAD or computer) and are presented with short screening questions, which an AI engine uses to recommend personalized and culturally tailored VR ready CaP interventions facilitated by a digital human character (CaP survivor, physician, or a psycho-oncologist) 3 months later on study.

ARM II (EARLY START INTERVENTION): Patients receive access to the ViRA app (on a VR headset, smartphone, iPAD or computer) and are presented with short screening questions, which an AI engine uses to recommend personalized and culturally tailored VR ready CaP interventions facilitated by a digital human character (CaP survivor, physician, or a psycho-oncologist) on study.

After completion of study intervention, patients are followed up at 1, 3, 6, 9 and 12 months.

03

Conditions studied

  • Prostate Carcinoma

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04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • African American/Black male
  • Diagnosed with CaP within two months
  • Be a patient at a participating clinic or affiliates with one of our community sites
  • Consent to participating in the study

Exclusion criteria

Exclusion Criteria:

  • Do not speak or understand English
  • Unable to read or write
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Arm I (delayed-start intervention [ViRA application])

    Patients receive standard care and then receive access to the ViRA app (on a VR headset, smartphone, iPAD or computer) and are presented with short screening questions, which an AI engine uses to recommend personalized and culturally tailored VR ready CaP interventions facilitated by a digital human character (CaP survivor, physician, or a psycho-oncologist) 3 months later on study.

    Other: Best Practice · Other: Discussion · Other: Survey Administration · Procedure: Virtual Reality

  • Experimental
    Arm II (ViRA application)

    Patients receive access to the ViRA app (on a VR headset, smartphone, iPAD or computer) and are presented with short screening questions, which an AI engine uses to recommend personalized and culturally tailored VR ready CaP interventions facilitated by a digital human character (CaP survivor, physician, or a psycho-oncologist) on study.

    Other: Discussion · Other: Survey Administration · Procedure: Virtual Reality

Interventions

  • OtherBest Practice

    Receive standard care

    Also known as: standard of care, standard therapy

  • OtherDiscussion

    Ancillary studies

    Also known as: Discuss

  • OtherSurvey Administration

    Ancillary studies

  • ProcedureVirtual Reality

    Receive access to ViRA application

    Also known as: VR

06

What researchers measure

Primary outcomes

  1. Reach - enrollment

    Reach of the point of prostate cancer diagnosis (PPCD) virtual reality assistant (ViRA) will be measured by the number of AA/BM who enroll in the study when offered.

    Time frame: Baseline

  2. Reach - acceptance of ViRA

    Reach of the PPCD ViRA will be measured by the % of AA/BM who accept the ViRA when offered.

    Time frame: Baseline

  3. Reach - initiation of ViRA

    Reach of the PPCD ViRA will be measured by the number of AA/BM who initiate the ViRA at the clinic vs. home vs. community setting.

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

  4. Utilization of the PPCD ViRA

    Will be measured by total # of AA/BM who used the Vira at least once a week.

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

Secondary outcomes

  1. Change in social determinants of health (SDOH) navigation

    Will be assessed by participant self-reported ability to find help for daily needs such as food, housing, reliable transportation for medical appointments.

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

  2. Change in emotional support

    Will be measured using the Positive Affect and Negative Affect Schedule-Expanded Form (PANAS-X), a 60-item questionnaire designed to measure a person's emotional state, both positive and negative, during a specific time frame. Participants rate how they feel on a 5-point Likert scale for each item (e.g., "right now" or "in general"). For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect.

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

  3. Psycho-oncology support

    Assessed by providers using National Comprehensive Cancer Network (NCCN) Guidelines Version 1.2024 Distress Management.

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Sep 2029, 40 months after the start.

Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 40 months is close to that.

Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.

Start moved once since we started tracking on Sep 25, 2026: Jun 2027 → Apr 2026, on Sep 25, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2025
First posted
Aug 17, 2025
StartActual
Apr 24, 2026was Jun 2027
Primary completionEst.
Sep 2, 2029
CompletionEst.
Sep 2, 2029
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 25, 2026
Sites
Mayo Clinic in Florida is now Recruiting
Sep 25, 2026
Start date
Jun 1, 2027→Apr 24, 2026 (actual)
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Not yet recruiting→Recruiting
    Mayo Clinic in Florida is now Recruiting
    Start date Jun 1, 2027→Apr 24, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07126548
Lead sponsor
Mayo Clinic
Collaborators
Congressionally Directed Medical Research Programs
Responsible party
Sponsor
First posted
Aug 17, 2025
Start date
Apr 24, 2026
Primary completion
Sep 2, 2029 (estimated)
Completion
Sep 2, 2029 (estimated)
Last update
Sep 25, 2026

Study contacts

Dee Glaser-Boivin
Contact
GlaserBoivin.Denielle@mayo.edu
904-953-4759
Clinical Trials Referral Office
Contact
mayocliniccancerstudies@mayo.edu
855-776-0015
Folakemi T. Odedina, PhD
principal investigator · Mayo Clinic

Oversight

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

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