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

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.

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