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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

Tracking Information
First Submitted Date June 3, 2011
First Posted Date June 20, 2011
Last Update Posted Date April 2, 2021
Actual Study Start Date May 2009
Actual Primary Completion Date September 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2012)
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
Original Primary Outcome Measures
 (submitted: June 16, 2011)
To monitor the feasibility and outcome of the Active Surveillance Program for men with low risk prostate cancer [ Time Frame: 10 years ]
Percentage of enrolled subjects who remain compliant until disease progression.
Change History
Current Secondary Outcome Measures
 (submitted: January 23, 2012)
  • Percentage of enrolled subjects who require definitive therapy [ Time Frame: 10 years ]
  • Quality of Life as measured by patient survey. [ Time Frame: 10 Years ]
  • Overall survival [ Time Frame: 10 years ]
    This will be a measurement of the treatment outcome.
  • Cost/Benefit Analysis [ Time Frame: 10 Years ]
    This measure will determine the feasibility of the Active Surveillance Program.
Original Secondary Outcome Measures
 (submitted: June 16, 2011)
To monitor the outcome of the Active Surveillance Program for men with low risk prostate cancer [ Time Frame: 10 years ]
Percentage of enrolled subjects who require devinitive therapy Quality of life Treatment outcomes Overal Survival Cost benefit analysis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study
Official Title Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Men with low risk prostate cancer.
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Active Surveillance/ Prostate Cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 30, 2021)
8
Original Estimated Enrollment
 (submitted: June 16, 2011)
500
Actual Study Completion Date September 1, 2016
Actual Primary Completion Date September 1, 2016   (Final data collection date for primary outcome measure)
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

Exclusion Criteria:

  • See inclusion criteria for eligibility
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01376661
Other Study ID Numbers 09-009 Active Surveillance
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party St. Joseph Hospital of Orange
Original Responsible Party Matthew Greenberger, MD / Principal Investigator, The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange
Current Study Sponsor St. Joseph Hospital of Orange
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Matthew Greenberger, MD St. Joseph Hospital of Orange
PRS Account St. Joseph Hospital of Orange
Verification Date March 2021