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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01376661
• Other study ID #: 09-009 Active Surveillance
• Status: Terminated
• Start date: May 2009
• Est. completion date: September 1, 2016

Study information

• Verified date: March 2021
• Source: St. Joseph Hospital of Orange
• Contact: n/a
• Is FDA regulated: No
• 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 1, 2016
• Est. primary completion date: September 1, 2016
• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

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, 

Outcome

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