RecruitingNANCT07535541

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)

Sponsor: University of Virginia

Trial Details

ConditionProstate Cancer, Hot Flashes
InterventionVMS logging
PhaseNA
StatusRecruiting
Participants18
Est. Completion1 May 2027
Last Updated9 June 2026

Primary Outcome

Duration of wear per day; Percent of days with self-reported time marked vasomotor events; Concordance between time marked vasomotor events and events described through EMAs.

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male (biologic sex), aged ≥18 years of age 4. Diagnosis of prostate cancer 5. 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 6. Evidence of castrate level testosterone by either of the following: 1. A documented serum testosterone level of \<50 ng/dL at any time point since initiation of ADT or 2. 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) 7. Duration of ADT expected to extend for a minimum of 4 weeks from time of study enrollment 8. Report experiencing VMS that began after initiation of ADT and occur with a minimum frequency of once per day 9. 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. 1. iPhone 8 or higher with iOS 16.0 or higher 2. Android devices version 12, 12.1, 13, 14, 15, or higher 10. Ability to read, speak, and understand English 11. ECOG performance status of 0, 1, or 2 Exclusion Criteria: 1. Wrist circumference less than 95 mm or greater than 222 mm 2. Known allergic reactions to components of the EmbracePlus smart watch, specifically any skin allergy to silicone 3. Presence of VMS prior to initiation of ADT, regardless of severity or duration 4. Active febrile illness (temperature \>38°C) or on active treatment for febrile illness 5. Inability to press button on smart watch crown 6. Those receiving any experimental therapy for treatment of their prostate cancer (other standard of care prostate cancer therapies are permitted) 7. Evidence of progression of prostate cancer as defined by PCWG3 criteria

Trial Sites

Countries

United States
View Registry Entry

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