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)
Recruiting · NCT07535541 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Virginia
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 it is running
1 location listed across 1 US state.
- University of Virginia Health System - Charlottesville, Virginia, United States