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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01376661
Recruitment Status : Terminated (Early termination due to PI's decision to discontinue research activities.)
First Posted : June 20, 2011
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
St. Joseph Hospital of Orange

Study Description
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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.

Condition or disease
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.
Study Design
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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study
Actual Study Start Date : May 2009
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : September 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort
Active Surveillance/ Prostate Cancer


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percentage of enrolled subjects who require definitive therapy [ Time Frame: 10 years ]
  2. Quality of Life as measured by patient survey. [ Time Frame: 10 Years ]
  3. Overall survival [ Time Frame: 10 years ]
    This will be a measurement of the treatment outcome.

  4. Cost/Benefit Analysis [ Time Frame: 10 Years ]
    This measure will determine the feasibility of the Active Surveillance Program.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376661


Locations
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United States, California
St. Joseph Hospital of Orange
Orange, California, United States, 92868
Sponsors and Collaborators
St. Joseph Hospital of Orange
Investigators
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Principal Investigator: Matthew Greenberger, MD St. Joseph Hospital of Orange
More Information
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Responsible Party: St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier: NCT01376661    
Other Study ID Numbers: 09-009 Active Surveillance
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021
Keywords provided by St. Joseph Hospital of Orange:
Prostate Cancer
Active Surveillance
Low risk prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases