Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT07535541

Conditions

Prostate Cancer

Hot Flashes

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VMS logging

Study Details

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.

Conditions

Prostate Cancer

Hot Flashes

Study ID

NCT07535541

Start date

May 21, 2026

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Smartwatch for VMS Logging

Participants will be asked to wear a smartwatch during daily life and log VMS events by pressing a designated button on a smartwatch device. Participants will be asked to wear the watch for the duration of the study.

Participants will receive daily electronic (Ecological Momentary Assessments) EMAs from the UVA Qualtrics platform via text message link. EMAs are used to record VMS frequency and subjective experiences.

Interventions

VMS logging

Wearing of smartwatch and logging VMS

Primary outcome measure

  • Duration of wear per day [ Time Frame: 28 days ]
  • Percent of days with self-reported time marked vasomotor events [ Time Frame: 28 days ]
  • Concordance between time marked vasomotor events and events described through EMAs. [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

More Information

Sponsor

University of Virginia

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • VMS
  • Hot flashes
  • ADT
  • Prostate Cancer
  • vasomotor symptoms
  • vasomotor symptom event
  • Smartwatch
  • Survey
  • EMA
  • androgen deprivation therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-06-09.