NCT07535541 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)
| NCT ID | NCT07535541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Virginia |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-05-21 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2026-05-21 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Michael Devitt, MD
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT07535541 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07535541 currently recruiting?
Yes, NCT07535541 is actively recruiting participants. Contact the research team at Cus9jd@uvahealth.org for enrollment information.
Where is the NCT07535541 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT07535541 clinical trial?
NCT07535541 is sponsored by University of Virginia. The principal investigator is Michael Devitt, MD at University of Virginia. The trial plans to enroll 18 participants.
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