A Feasibility Study of Biometric Measurements Via Wearable Smart Watch Technology for Evaluation … (NCT07535541) | Clinical Trial Compass
RecruitingNot Applicable
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)
United States18 participantsStarted 2026-05
Plain-language summary
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 participate
Age range18 Years
SexMALE
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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
✓. 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)
Exclusion criteria
✕. Wrist circumference less than 95 mm or greater than 222 mm
What they're measuring
1
Duration of wear per day
Timeframe: 28 days
2
Percent of days with self-reported time marked vasomotor events
Timeframe: 28 days
3
Concordance between time marked vasomotor events and events described through EMAs.