Actively Recruiting
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)
Led by University of Virginia · Updated on 2026-05-08
18
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
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 (Prostate 007)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for study duration
- Male participants aged 18 years or older
- Diagnosis of prostate cancer
- Currently receiving active androgen deprivation therapy (ADT) to lower serum testosterone below 50 mg/dL
- Evidence of castrate level testosterone by documented serum testosterone <50 ng/dL or PSA decrease without progression
- Expected to continue ADT for at least 4 weeks after enrollment
- Experiencing vasomotor symptoms (hot flashes) that began after starting ADT, occurring at least once daily
- Own a smartphone with Bluetooth 5 compatibility (iPhone 8 or higher with iOS 16.0+, or Android 12 or higher)
- Ability to read, speak, and understand English
- ECOG performance status of 0, 1, or 2
You will not qualify if you...
- Wrist circumference less than 95 mm or greater than 222 mm
- Known allergy to EmbracePlus smartwatch materials, especially silicone
- Vasomotor symptoms present before starting ADT
- Active fever (temperature above 38�b0C) or currently treated for febrile illness
- Unable to press the button on the smartwatch crown
- Receiving experimental therapies for prostate cancer treatment
- Evidence of prostate cancer progression as defined by PCWG3 criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
A
Ana Doder
CONTACT
E
Emily Leytham
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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