NCT07535541 · 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 (Prostate 007)
(BioWEAR)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
VMS logging
Wearing of smartwatch and logging VMS
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- ECOG performance status of 0, 1, or 2
Exclusion criteria
- 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
Where
- Charlottesville, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 9, 2026 · Source of record for eligibility and locations