A Feasibility Study of Biometric Measurements Via Wearable Smart Watch Technology for Evaluation of Vasomotor Symptoms in Patients Treated With Androgen Deprivation Therapy for Prostate Cancer (Prostate 007) (BioWEAR)

May 4, 2026 updated by: Michael E. Devitt, University of Virginia

A Feasibility Study of Biometric Measurements Via Wearable Smart Watch Technology for Evaluation of Vasomotor Symptoms in Patients Treated With Androgen Deprivation Therapy for Prostate Cancer (BioWEAR)

The purpose of this study is to find out if patients with prostate cancer who have vasomotor symptoms, commonly called hot flashes, from their Androgen Deprivation Therapy (ADT) will consistently wear a smartwatch device to track their health data, log hot flashes on their smartwatch, and how these data compare with daily surveys about their hot flashes. Participants will be asked to wear the smartwatch for 4 weeks and to log their hot flashes on their smart watch pressing a button on the watch. Participants will be asked to complete surveys (sent through a text message link) to describe their experiences with hot flashes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants in this study will be asked to log vasomotor symptoms events (VMS or hot flashes) via a smartwatch device and record VMS frequency and subjective experiences via daily electronic surveys.

After a consent is signed and eligibility is confirmed, participants will receive an EmbracePlus (Empatica, Inc.) smartwatch, corresponding charging device, and manual. Participants will download the Empatica Care smartphone application.

The study team will verify successful pairing of the EmbracePlus smartwatch to the participant's smart phone and the collection of biometric data. The study team will instruct participants on use of the device, including instructions on logging VMS events. This orientation will occur at the University of Virginia. The smartwatches and charging devices must be returned to the study team.

Participants will then take the watch home and be asked to continuously wear their EmbracePlus smartwatch (with the exception of time needed to charge the device) for the duration of the study.

Participants will be asked to log VMS event by pressing a designated button on the smartwatch device for one second, once at the beginning and once at the conclusion of an event.

Data will be transmitted via Bluetooth connection from the EmbracePlus smartwatch to the Empatica Care smartphone application. Data will then be transferred from the app to the Empatica Cloud server, where the research team will access and monitor the data. The Empatica Health Monitoring Platform received initial FDA clearance in 2022.

Participants will receive electronic EMAs from the UVA Qualtrics platform up to 4 times per day, for 28 days.

Participants will receive a check-in call and an end of study survey.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male (biologic sex), aged ≥18 years of age
  4. Diagnosis of prostate cancer

  5. Must be receiving active treatment with ADT at the time of enrollment

    a. ADT is defined as any medical or surgical intervention intended to lower the serum testosterone to <50 mg/dL for the purpose of treating prostate cancer

  6. Evidence of castrate level testosterone by either of the following:

    1. A documented serum testosterone level of <50 ng/dL at any time point since initiation of ADT or
    2. A documented decrease in PSA following initiation of ADT and no evidence of PSA progression per PCWG3 criteria (PSA progression defined as a rise in PSA of ≥25% from PSA nadir and absolute increase of ≥1 ng/mL confirmed by a second measurement at least 3 weeks later)
  7. Duration of ADT expected to extend for a minimum of 4 weeks from time of study enrollment
  8. Report experiencing VMS that began after initiation of ADT and occur with a minimum frequency of once per day

  9. Own a smartphone with Bluetooth 5 compatibility and be willing to use cellular data and/or Wi-Fi on their smartphone. Participants must agree to download the Empatica Care app on their smartphone.

    1. iPhone 8 or higher with iOS 16.0 or higher
    2. Android devices version 12, 12.1, 13, 14, 15, or higher
  10. Ability to read, speak, and understand English
  11. ECOG performance status of 0, 1, or 2

Exclusion Criteria:

  1. Wrist circumference less than 95 mm or greater than 222 mm
  2. Known allergic reactions to components of the EmbracePlus smart watch, specifically any skin allergy to silicone
  3. Presence of VMS prior to initiation of ADT, regardless of severity or duration
  4. Active febrile illness (temperature >38°C) or on active treatment for febrile illness
  5. Inability to press button on smart watch crown
  6. Those receiving any experimental therapy for treatment of their prostate cancer (other standard of care prostate cancer therapies are permitted)
  7. Evidence of progression of prostate cancer as defined by PCWG3 criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smartwatch for VMS Logging

Participants will be asked to wear a smartwatch during daily life and log VMS events by pressing a designated button on a smartwatch device. Participants will be asked to wear the watch for the duration of the study.

Participants will receive daily electronic (Ecological Momentary Assessments) EMAs from the UVA Qualtrics platform via text message link. EMAs are used to record VMS frequency and subjective experiences.
Behavioral: VMS logging
Wearing of smartwatch and logging VMS
Other Names:
  • Embrace Plus (Empatica Inc.) Smartwatch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of wear per day
Time Frame: 28 days
For each participant, we will calculate the duration of device wear for each day using the real-time data recorded by the device and estimate the mean daily duration.
28 days
Percent of days with self-reported time marked vasomotor events
Time Frame: 28 days
Percent of days with self-reported time marked vasomotor events, using the real-time marked vasomotor events from the device.
28 days
Concordance between time marked vasomotor events and events described through EMAs.
Time Frame: 28 days
Concordance between time marked vasomotor events and EMA reporting of vasomotor events during the corresponding time period.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who complete the post-intervention visit
Time Frame: 28 days
Number of participants who complete the post-intervention visit
28 days
Post intervention survey
Time Frame: 28 days
Post intervention survey
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Michael Devitt, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR302801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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