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

This study is currently recruiting participants.
Verified September 2012 by St. Joseph Hospital of Orange
Sponsor:
Information provided by (Responsible Party):
St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier:
NCT01376661
First received: June 3, 2011
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Joseph Hospital of Orange:

Primary Outcome Measures:
  • Percentage of enrolled subjects who remain compliant free until disease progression. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    This measurement will monitor the feasibility of the Active Surveillance Program for men with low risk prostate cancer


Secondary Outcome Measures:
  • Percentage of enrolled subjects who require definitive therapy [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Quality of Life as measured by patient survey. [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    This will be a measurement of the treatment outcome.

  • Cost/Benefit Analysis [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
    This measure will determine the feasibility of the Active Surveillance Program.


Estimated Enrollment: 500
Study Start Date: May 2009
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Active Surveillance/ 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men with low risk prostate cancer.

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

Exclusion Criteria:

  • See inclusion criteria for eligibility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376661

Contacts
Contact: Maria Gonzalez 714-734-6220 Maria1.Gonzalez@stjoe.org
Contact: Heather Weiss 714-734-6220 Heather.Weiss@stjoe.org

Locations
United States, California
St. Joseph Hospital of Orange Recruiting
Orange, California, United States, 92868
Contact: Gitana Davila     714-734-6200 ext 41477     Gitana.Davila@stjoe.org    
Contact: Heather Weiss     714-734-6220     Heather.Weiss@stjoe.org    
Sub-Investigator: William Pearce, MD            
Sub-Investigator: Brian Norouzi, MD            
Sub-Investigator: Ashok Kar, MD            
Sub-Investigator: Martin Weissman, MD            
Sub-Investigator: Robert Ash, MD            
Sub-Investigator: Afshin Forouzannia, MD            
Sub-Investigator: Venita Williams, MD            
Sponsors and Collaborators
St. Joseph Hospital of Orange
Investigators
Principal Investigator: Matthew Greenberger, MD St. Joseph Hospital of Orange
  More Information

No publications provided

Responsible Party: St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier: NCT01376661     History of Changes
Other Study ID Numbers: 09-009 Active Surveillance
Study First Received: June 3, 2011
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Joseph Hospital of Orange:
Prostate Cancer
Active Surveillance
Low risk prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013