Expanded criteria to identify men eligible for active surveillance of low risk prostate cancer at Johns Hopkins: a preliminary analysis.

PURPOSE: At our institution the eligibility criteria used to enroll patients in active surveillance are clinical stage T1, prostate specific antigen density less than 0.15 ng/ml, biopsy Gleason score 6 or less, 2 or fewer positive biopsy cores and 50% or less involvement of any biopsy core. We hypothesized that these criteria may be excessively strict, precluding many men from active surveillance.
MATERIALS AND METHODS: We studied pathological outcomes in men treated with radical prostatectomy between 1995 and 2012 who met 4 or more of the 5 active surveillance criteria. Outcomes included a definition of significant tumor (pathological Gleason 7 or greater, or nonorgan confined). We compared adverse pathology rates between men who met all 5 vs 4 of 5 active surveillance criteria.
RESULTS: Of 8,261 men 1,890 (22.9%) met all active surveillance eligibility criteria and 2,133 (25.8%) met 4. Men with values exceeding prostate specific antigen density and biopsy Gleason criteria were at increased risk for adverse pathological outcomes. Clinical stage greater than T1 was not associated with adverse pathological findings. The risk of significant tumors in men with clinical stage T2 lesions, 3 or fewer positive biopsy cores and less than 60% core involvement was comparable to that of men who met all active surveillance criteria.
CONCLUSIONS: Prostate specific antigen density greater than 0.15 ng/ml and biopsy Gleason score 7 or greater are strongly associated with adverse pathological findings at radical prostatectomy. Our findings suggest that active surveillance criteria should be expanded to include men with clinical stage T2 lesions and a greater number of positive biopsy cores of low grade. Based on these preliminary findings, we are in the process of reassessing active surveillance eligibility criteria using more detailed pathological analysis.