Prostate CancerBioWEARNCT07535541
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)
A study testing VMS logging in people with Prostate Cancer and Hot Flashes, run by University of Virginia at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Hot Flashes
- What is being tested?
- VMS logging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male (biologic sex), aged ≥18 years of age
- Diagnosis of prostate cancer
- Must be receiving active treatment with ADT at the time of enrollment
- 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
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- Evidence of castrate level testosterone by either of the following:
- A documented serum testosterone level of <50 ng/dL at any time point since initiation of ADT or
- 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)
- Duration of ADT expected to extend for a minimum of 4 weeks from time of study enrollment
- Report experiencing VMS that began after initiation of ADT and occur with a minimum frequency of once per day
- 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.
- iPhone 8 or higher with iOS 16.0 or higher
- Android devices version 12, 12.1, 13, 14, 15, or higher
- Ability to read, speak, and understand English
- ECOG performance status of 0, 1, or 2
Who cannot join
- Wrist circumference less than 95 mm or greater than 222 mm
- Known allergic reactions to components of the EmbracePlus smart watch, specifically any skin allergy to silicone
- Presence of VMS prior to initiation of ADT, regardless of severity or duration
- Active febrile illness (temperature >38°C) or on active treatment for febrile illness
- Inability to press button on smart watch crown
- Those receiving any experimental therapy for treatment of their prostate cancer (other standard of care prostate cancer therapies are permitted)
- Evidence of progression of prostate cancer as defined by PCWG3 criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily Leytham contact
United States1 site, 1 recruiting
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Hot Flashes
- Being tested
- VMS logging
- Keywords
- VMS, Hot flashes, ADT, Prostate Cancer, vasomotor symptoms, vasomotor symptom event, Smartwatch, Survey, EMA, androgen deprivation therapy
- Medical subject headings
- Prostatic Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMS loggingBehavioural
Also called Embrace Plus (Empatica Inc.) Smartwatch
Wearing of smartwatch and logging VMS
| Study group | Role | What they receive |
|---|---|---|
| Smartwatch for VMS Logging | Experimental | 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. Receives: Behavioral: VMS logging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of wear per day
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.
Measured: 28 days
Percent of days with self-reported time marked vasomotor events
Percent of days with self-reported time marked vasomotor events, using the real-time marked vasomotor events from the device.
Measured: 28 days
Concordance between time marked vasomotor events and events described through EMAs.
Concordance between time marked vasomotor events and EMA reporting of vasomotor events during the corresponding time period.
Measured: 28 days
Secondary outcomes (2)
Number of participants who complete the post-intervention visit
Number of participants who complete the post-intervention visit
Measured: 28 days
Post intervention survey
Post intervention survey
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start21 May 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael E. Devitt, University of Virginia
- Investigators
- Michael Devitt, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535541
- Sponsor's protocol ID
- HSR302801
- Acronym
- BioWEAR
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07535541
- Acronym / sponsor ID
- BioWEAR / HSR302801
- Conditions
- Prostate Cancer, Hot Flashes
- Keywords
- VMS, Hot flashes, ADT, Prostate Cancer, vasomotor symptoms, vasomotor symptom event, Smartwatch, Survey
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 21 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| Smartwatch for VMS Logging | Experimental | Behavioral: VMS loggingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male (biologic sex), aged ≥18 years of age
- Diagnosis of prostate cancer
- Must be receiving active treatment with ADT at the time of enrollment
Key exclusion criteria (7 listed)
- Wrist circumference less than 95 mm or greater than 222 mm
- Known allergic reactions to components of the EmbracePlus smart watch, specifically any skin allergy to silicone
- Presence of VMS prior to initiation of ADT, regardless of severity or duration
- Active febrile illness (temperature >38°C) or on active treatment for febrile illness
- Inability to press button on smart watch crown
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 |
|---|---|---|
| VMS loggingAlso: Embrace Plus (Empatica Inc.) SmartwatchWearing of smartwatch and logging VMS | Behavioural | Smartwatch for VMS Logging |
Primary outcome
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.
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.
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.
2 secondary outcomes
Number of participants who complete the post-intervention visit
Time frame: 28 days
Post intervention survey
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Emily Leytham contact
Michael Devitt, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VMS logging in people with Prostate Cancer and Hot Flashes, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 9 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Doder (434-421-5577, Cus9jd@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of wear per day (time frame: 28 days). 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?
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 9 Jun 2026.