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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Surveillance/ Prostate Cancer<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of enrolled subjects who remain compliant free until disease progression. | This measurement will monitor the feasibility of the Active Surveillance Program for men with low risk prostate cancer | 10 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Active Surveillance, Low risk prostate cancer, Prostate Cancer