NCT05840484

Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prostate cancer is the most commonly diagnosed cancer in men. However, there is a wide range in prognosis determined by a host of factors. This study will evaluate the feasibility of guiding therapeutic intervention electronically facilitated symptom and disease monitoring in patients being followed on Active Surveillance. Additionally, we will develop a tissue and data resource to support discovery and hypothesis generation to evaluate germline and/or somatic alterations in relation to cancer-specific and overall outcomes..

Detailed description

Primary objectives: 1\. Monitor cancer-specific outcomes of men who meet consensus criteria for active surveillance under one of three categories: 1) low or very low-risk prostate cancer, 2) intermediate risk with patient consent, or 3) severe medical comorbidities and high-risk localized prostate cancer or patient desire, despite recommendation Secondary objectives: 1. Screen for a relationship between cancer-specific and clinical outcomes related to selected comorbidities. 2. Determine the feasibility of electronically facilitated symptoms and disease monitoring to guide therapeutic intervention and prompt therapeutic course correction. 3. Develop a tissue and data resource to support discovery and hypothesis generation focused on germline alterations, somatic alterations, and/or the interaction between the two in determining cancer-specific and overall outcomes

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Active Surveillance	Participants will be asked to complete questionnaires, have physical and rectal examinations, have prostate biopsies, and have imaging scans (such as MRIs). These visits will be done between every 6 months and every 2-3 years, depending on the test/procedure.

Timeline

• Start date: 2023-03-29
• Primary completion: 2029-07-30
• Completion: 2029-07-30
• First posted: 2023-05-03
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States