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

March 30, 2021 updated by: St. Joseph Hospital of Orange
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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • St. Joseph Hospital of Orange

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men with low risk prostate cancer.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Active Surveillance/ Prostate Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of enrolled subjects who remain compliant free until disease progression.
Time Frame: 10 years
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
Time Frame: 10 years
10 years
Quality of Life as measured by patient survey.
Time Frame: 10 Years
10 Years
Overall survival
Time Frame: 10 years
This will be a measurement of the treatment outcome.
10 years
Cost/Benefit Analysis
Time Frame: 10 Years
This measure will determine the feasibility of the Active Surveillance Program.
10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph Hospital of Orange

Investigators

  • Principal Investigator: Matthew Greenberger, MD, St. Joseph Hospital of Orange

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2009

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 3, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (Estimate)

June 20, 2011

Study Record Updates

Last Update Posted (Actual)

April 2, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-009 Active Surveillance

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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