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

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT01376661
• Lead Sponsor: St. Joseph Hospital of Orange

Brief 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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-20
• Primary Completion: 2016-09-01
• Study Completion: 2016-09-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• At least 18 years of age
• Histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. Subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated.
• PSA < 10 ng/ml within 1 month of program enrollment
• Clinical stage less than or equal to T2a
• Biopsy sampling with at least 10-12 cores
• Gleason score less than or equal to 3 + 3
• No more than 2 cores involved
• No core more than 50% involved
• Eligible for definitive therapy
• Able to provide informed consent
• Able to complete a QOL questionnaire
• Able to comply with the scheduled follow-up appointments

Exclusion Criteria

• See inclusion criteria for eligibility

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of enrolled subjects who remain compliant free until disease progression.	10 years	This measurement will monitor the feasibility of the Active Surveillance Program for men with low risk prostate cancer

Secondary Outcome Measures

Name	Time	Method
Percentage of enrolled subjects who require definitive therapy	10 years
Overall survival	10 years	This will be a measurement of the treatment outcome.
Quality of Life as measured by patient survey.	10 Years
Cost/Benefit Analysis	10 Years	This measure will determine the feasibility of the Active Surveillance Program.

Trial Locations

Locations (1)

St. Joseph Hospital of Orange; 🇺🇸 Orange, California, United States