NCT06215508

Geriatric Assessment and Technology Evaluation in Prostate Cancer

Prostate Cancer Geriatric Assessment and Technology Evaluation (ProsGATE) Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: Male
• Age: 18 Minutes
• Healthy volunteers: Not accepted

Summary

By doing this study, doctors hope to learn more about factors that contribute to frailty (a condition where older adults feel weak, get tired easily, and struggle more with everyday activities) and serious side effects among men over the age of 65 who will receive androgen deprivation therapy (also called "hormone therapy") for prostate cancer that has spread to other parts of their body. Participation in this research will last about 5 years. For the first year, participants will have 5 study visits where they have give blood samples, answer survey questions, and use a wearable device. After study visits are complete, there is a 4-year follow-up period. Research team will check regular doctor visits and look at participants' medical records.

Detailed description

By doing this study, doctors hope to learn more about factors that contribute to frailty (a condition where older adults feel weak, get tired easily, and struggle more with everyday activities) and serious side effects among men over the age of 65 who will receive androgen deprivation therapy (also called "hormone therapy") for prostate cancer that has spread to other parts of their body. Participation in this research will last about 5 years. For the first year, participants will have 5 study visits where they have give blood samples, answer survey questions, and use a wearable device. After study visits are complete, there is a 4-year follow-up period. Research team will check regular doctor visits and look at participants' medical records. The purpose of this research is to gather information about the physical, mental, and social health of study participants to help the research team identify factors that put older men with prostate cancer at greater risk for developing serious side effects during hormone therapy. This study is for individuals who are over the age of 65 and plan to receive hormone therapy as part of standard treatment for their prostate cancer. Participants will receive androgen deprivation therapy as part of their standard care with their doctor outside of this study. No drugs or treatments will be given in this study. Participants will instead fill out questionnaires, provide blood samples, and wear a smartwatch paired to a mobile application downloaded to the their personal smartphone or a phone/tablet provided by the research team. This application will help the research team collect information about each study participants' levels of function, general health, physical activity, body composition, memory, mood and side effects during hormone therapy. By collecting this information, doctors leading the study ultimately hope to learn new ways to potentially improve treatment options for older men with prostate cancer while lowering their risks for serious side effects.

Conditions

• Prostate Cancer
• Prostate Cancer Metastatic

Interventions

Type	Name	Description
OTHER	Questionnaires	Questionnaires participants fill out at different study visits

Timeline

• Start date: 2026-04-01
• Primary completion: 2031-04-01
• Completion: 2031-04-01
• First posted: 2024-01-22
• Last updated: 2025-06-08

Locations

1 site across 1 country: United States