Clinical trial NCT01376661: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Active Surveillance
Low risk prostate cancer
Lead sponsor: St. Joseph Hospital of Orange
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with low risk prostate cancer.

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.

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

Primary outcomes:
measure: Percentage of enrolled subjects who remain compliant free until disease progression.
timeFrame: 10 years
Secondary outcomes:
measure: Percentage of enrolled subjects who require definitive therapy
timeFrame: 10 years
measure: Quality of Life as measured by patient survey.
timeFrame: 10 Years
measure: Overall survival
timeFrame: 10 years
measure: Cost/Benefit Analysis
timeFrame: 10 Years
Other outcomes:
Locations:
city: Orange
country: United States
facility: St. Joseph Hospital of Orange
state: California
Study officials:
affiliation: St. Joseph Hospital of Orange
name: Matthew Greenberger, MD
role: PRINCIPAL_INVESTIGATOR
References: