Eligibility criteria for active surveillance among men with low-risk prostate cancer

As regular readers of this blog will be aware, the urology group at Johns Hopkins in Baltimore has, for the past several years, had one of the most restrictive sets of criteria for eligibility for active surveillance as an appropriate method for the management of men initially diagnosed with low- and very low-risk prostate cancer.

Historically, Johns Hopkins has required men to meet all five of the following criteria:

  • A clinical stage of T1
  • A PSA density of less than 0.15 ng/ml
  • A biopsy-based Gleason score of 6 or less
  • A maximum of two positive biopsy cores, and
  • ≤ 50 percent involvement of any biopsy core

In an article just published in the current issue of the Journal of Urology, Reese et al. report that a careful re-evaluation of the available data on their patients has encouraged Johns Hopkins to expand their eligibility criteria.

According to the analysis reported by Reese et al.:

  • 1,890/8,261 men in the Johns Hopkins database (22.9 percent) met all of the above surveillance eligibility criteria
  • 2,133/8,261 men (25.8 percent) met  four of the five criteria.
  • Men who failed to meet the PSA density and biopsy Gleason criteria were clearly at increased risk for adverse pathological outcomes at surgery.
  • A clinical stage > T1 was not necessarily associated with adverse pathological findings.
  • Among men with clinical stage T2 lesions, up to three biopsy cores and less than 60 percent of core involvement was associated with a risk level comparable to that of men who met all five current active surveillance criteria.

Reese et al. conclude that a PSA density > 0.15 ng/ml and a biopsy-based Gleason score of ≥ 7 are strongly associated with adverse pathological findings at radical prostatectomy and so patients with either one of these findings are probably not appropriate candidates for active surveillance. However, they also conclude that:

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.

Apparently Johns Hopkins is currently reassessing its active surveillance eligibility criteria based on a more detailed pathological analysis, and The “New” Prostate Cancer InfoLink looks forward to evaluating these new eligibility criteria as soon as they become available. Regular readers will be aware that we have long felt that the Johns Hopkins criteria were overly restrictive when compared to the criteria used by other centers with significant experience of the application of active surveillance. We see this as a very positive finding that will expand confidence in active surveillance as a means to manage men diagnosed with low- and very low-risk forms of prostate cancer

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