NCT07535541Recruiting
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 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)
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 31 Mar 2026
- Start date
- 21 May 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- University of Virginia
- Diseases
- Prostate cancer
- NCT number
- NCT07535541
What you commit to
- Study type: Interventional
- Planned participants: 18
- From 21 May 2026 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of VMS prior to initiation of ADT, regardless of severity or duration
- Those receiving any experimental therapy for treatment of their prostate cancer (other standard of care prostate cancer therapies are permitted)
Other illness
- Known allergic reactions to components of the EmbracePlus smart watch, specifically any skin allergy to silicone
- Active febrile illness (temperature \>38°C) or on active treatment for febrile illness
- Evidence of progression of prostate cancer as defined by PCWG3 criteria
Other
- Wrist circumference less than 95 mm or greater than 222 mm
- Inability to press button on smart watch crown
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.