Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- St. Joseph Hospital of Orange
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Percentage of enrolled subjects who remain compliant free until disease progression.
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •See inclusion criteria for eligibility
Outcomes
Primary Outcomes
Percentage of enrolled subjects who remain compliant free until disease progression.
Time Frame: 10 years
This measurement will monitor the feasibility of the Active Surveillance Program for men with low risk prostate cancer
Secondary Outcomes
- Percentage of enrolled subjects who require definitive therapy(10 years)
- Overall survival(10 years)
- Quality of Life as measured by patient survey.(10 Years)
- Cost/Benefit Analysis(10 Years)