Active surveillance for men with PSA levels up to 20 ng/ml?

A forthcoming paper in the Journal of Urology has suggested that active surveillance may be an acceptable option for selected patients with a clinical stage of ≤ T2a, a Gleason score of ≤ 6, but PSA levels of up to 20 ng/ml.

In the majority of currently used recommendations for enrollment of patients on to active surveillance protocols, the upper level for a patient’s PSA has been < 10 ng/ml. The outstanding exception to that general rule has been the Sunnybrook series of Klotz and his colleagues in Canada, which has routinely accepted patients with PSA levels up to 15 ng/ml.

Yu et al. have now reported data from a prospectively maintained database of men with histologically favorable-risk prostate cancer who all underwent radical prostatectomy between 2003 and 2015.

This was a retrospective study (which means that it needs to be evaluated with caution) in which they assigned all the patients into one of three groups based on their PSA levels:

  • Group A: a low PSA level group, in which patients had a PSA of < 10 ng/ml
  • Group B: an intermediate PSA level group, in which patients had PSA levels ≥ 10 and <20 ng/ml
  • Group C: a high PSA level group, in which patients had PSA levels ≥20 ng/ml

Otherwise, all of the patients had favorable histopathology based on their initial evaluation and biopsy data (i.e., a Gleason score of ≤ 6 and a clinical stage of ≤ T2a).

Here is what Yu et al. report:

  • The cohort from which patients were selected if eligible numbered 2,125 patients.
  • 1,327/2,125 patients (62.4 percent) were categorized as having a histologically favorable-risk disease (but any PSA level)
  • Based on multivariate analysis, after radical prostatectomy,
    • The rates of upstaging and upgrading were similar for patients in Group A and Group B.
    • The rate of upstaging was higher in Group C than in Group B (p = 0.02).
    • The rate of upgrading to a Gleason score of ≥ 4 + 3 was higher in Group C than in Group B (p = 0.046).
    • Biochemical recurrence-free survival rates revealed no meaningful differences, except between patents in Group A and Group C.

The authors conclude that

Patients with elevation of preoperative PSA levels between 10 and 20 who otherwise had histologically favorable-risk [prostate cancer] were not at higher risk for having adverse pathologic outcomes when compared to men with PSA < 10.

The implication is that men with histologically favorable prostate cancer and a PSA level of up to 20 ng/ml may be very reasonable candidates for active surveillance.

Having said this, the full text of this paper is still under embargo and so we cannot yet report certain details from this paper. In addition, a key question relates to PSA density as a criterion for selection of good patients for active surveillance. Data from Johns Hopkins continue to suggest that patients with a PSA density of > 0.15 may be less good candidates for active surveillance. A man with a PSA level of 20 ng/ml would need to have a prostate volume of the order of 140 cm3 to have a PSA density of < 0.15. Prostates of this volume are not unknown, but such a volume is very high. While this paper by Yu et al. is interesting in that it suggests that at least some men with PSA levels ≥ 10 and < 20 may be good candidates for active surveillance, we will need more data to clarify some of the risk factors associated with active surveillance in men with PSA levels in that range.

2 Responses

  1. PSA 10 to < 20 Covers a Lot of Territory

    As Sitemaster noted, there has not been much study of this PSA range, with the Klotz series noted above as the "outstanding exception."

    It could well be that otherwise qualifying patients with PSAs up to around 15, or maybe a little less or a little more generally do well on active surveillance, while those at the upper end of the range have significantly less favorable results. This is reminiscent of risk stratification with Gleason scores, where a 3 + 4 = 7 is significantly more favorable than 4 + 3 = 7: the total is still 7, but the proportion of each grade constitutes a significant cut point.

    Prostate size data should be available for this cohort, and it will be interesting to see if the complete paper relates size or PSA density to the results in the abstract. With well over a thousand patients in the overall study, I suspect there are likely to be at least around 100 patients in Group C — the 10 to < 20 range for PSA. If so, perhaps there will have been enough so that the authors will have graphed success for each point of PSA in this range.

    Sometimes research resembles bracketing and homing in on the target with artillery. This study should foster further research on the PSA range of 10 to < 20.

    Thanks again Sitemaster for pointing out this interesting study.

  2. Very interesting, as my father who has been on active surveillance is nearing a crossroads. He has been on a steady climb and just peaked over 10.5 ng/ml. He is 81 and in great health. Given my history, it may be more reasonable that he takes on treatment with radiation than test the hypothesis. Thanks for the post. I’ll share it with him.

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