NCT01376661

Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: St. Joseph Hospital of Orange · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to monitor the feasibility and outcome of the Active Surveillance Program for men with low risk prostate cancer.

Detailed description

The purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at The Center for Cancer Prevention and Treatment at St. Joseph Hospital. We hope to demonstrate that men who are compliant with a closely monitored active surveillance program for low risk prostate cancer will achieve favorable outcomes by: 1) avoiding the side effects of definitive therapy that may not be necessary; 2) retaining quality of life (QOL) and normal activities; 3) avoiding unnecessary treatment; and 4) decreased health care costs. In addition, we will monitor the possible adverse outcomes that may be associated with the active surveillance program including suboptimal response and/or greater side effects due to delayed initiation of therapy; psychological impact on the patients and caregivers due to anxiety of living with an untreated cancer and/or the requirement for frequent medical examination and periodic prostate biopsies.

Conditions

• Prostate Cancer

Timeline

• Start date: 2009-05-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2011-06-20
• Last updated: 2021-04-02

Locations

1 site across 1 country: United States