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
1 other identifier
interventional
18
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Apr 2026
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
April 17, 2026
April 1, 2026
1.1 years
March 31, 2026
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
28 days
Secondary Outcomes (2)
Number of participants who complete the post-intervention visit
28 days
Post intervention survey
28 days
Study Arms (1)
Smartwatch for VMS Logging
EXPERIMENTALParticipants 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.
Interventions
Wearing of smartwatch and logging VMS
Eligibility Criteria
You may qualify if:
- 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
- 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
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Devitt, MD
University of Virginia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 31, 2026
First Posted
April 17, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04