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

NCT ID: NCT01376661

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2016-09-01

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Active Surveillance/ Prostate Cancer

No interventions assigned to this group

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
• Able to complete a QOL questionnaire
• Able to comply with the scheduled follow-up appointments

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph Hospital of Orange

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Greenberger, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph Hospital of Orange

Locations

St. Joseph Hospital of Orange

Orange, California, United States

Countries

United States

Other Identifiers

09-009 Active Surveillance

Identifier Type: -

Identifier Source: org_study_id