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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01376661
Other study ID # 09-009 Active Surveillance
Secondary ID
Status Recruiting
Phase N/A
First received June 3, 2011
Last updated September 12, 2012
Start date May 2009
Est. completion date April 2019

Study information

Verified date September 2012
Source St. Joseph Hospital of Orange
Contact Maria Gonzalez
Phone 714-734-6220
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.

Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 90 Years
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms


Country Name City State
United States St. Joseph Hospital of Orange Orange California

Sponsors (1)

Lead Sponsor Collaborator
St. Joseph Hospital of Orange

Country where clinical trial is conducted

United States, 


Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Percentage of enrolled subjects who require definitive therapy 10 years No
Secondary Quality of Life as measured by patient survey. 10 Years No
Secondary Overall survival This will be a measurement of the treatment outcome. 10 years No
Secondary Cost/Benefit Analysis This measure will determine the feasibility of the Active Surveillance Program. 10 Years No
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