PURPOSE: The following eligibility criteria are used to enroll patients in active surveillance (AS) at Johns Hopkins: clinical stage T1, PSA density < 0.15, biopsy Gleason score ≤ 6, ≤ 2 positive biopsy cores, and ≤ 50% involvement of any biopsy core.
We hypothesized that these criteria may be excessively strict, thereby precluding many men from AS.
MATERIALS AND METHODS: We studied pathological outcomes in men treated between 1995 and 2012 with radical prostatectomy (RP) who met ≥ 4 of 5 AS criteria. Outcomes included a definition of significant tumor (pathological Gleason ≥ 7 or non-organ confined). Rates of adverse pathology were compared between men meeting all versus 4 of 5 AS criteria.
RESULTS: Of 8261 men, 1890 (22.9%) met all AS eligibility criteria and 2133 (25.8%) met 4 of 5 criteria. Men exceeding PSA density and biopsy Gleason criteria were at increased risk of adverse pathological outcomes. Clinical stage > T1 was not associated with adverse pathology. Men with clinical stage T2 lesions, ≤ 3 positive biopsy cores, and < 60% core involvement were at comparable risk of significant tumors to men meeting all AS criteria.
CONCLUSIONS: PSA density > 0.15 ng/ml and biopsy Gleason score ≥ 7 are strongly associated with adverse pathology at RP. Our findings suggest expanding AS criteria 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 AS eligibility criteria using more detailed pathological analysis.
Reese AC, Landis P, Han M, Epstein JI, Carter HB. Are you the author?
Reference: J Urol. 2013 May 13. pii: S0022-5347(13)04351-6.