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

• ClinicalTrials.gov Identifier: NCT01376661
• Recruitment Status: Terminated
• First Posted: June 20, 2011
• Last Update Posted: April 2, 2021
• Sponsor: St. Joseph Hospital of Orange
• 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.

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

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

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