Active surveillance is absolutely NOT appropriate for all men with intermediate-risk prostate cancer


A paper to be presented this Thursday at the upcoming Genitourinary Cancers Symposium in  Orlando, Florida, will clearly confirm the above heading, which should come as no surprise to anyone. The issue has always been whether there is a subset of men with (“favorable”) intermediate-risk disease who are potentially appropriate candidates.

What Musunuru et al. will present on Thursday (from the Sunnybrook series in Canada) is the following information.

The Sunnybrook series included 237 AS patients (out of the 945 patients now eligible for analysis) who were formally classified as having intermediate-risk disease. In other words, they had at least one of a PSA level > 10 ng/ml, a Gleason score of 7, and/or a clinical stage of T2b/2c. The remaining 708 patients in the Sunnybrook series who were diagnosed between 1995 and 2013 and followed through 2013 all met classic criteria for low-risk disease.

All patients were offered treatment if any one of the following occurred:

  • Their PSA doubling time dropped to < 3 years.
  • There was Gleason score progression.
  • There were clear indications of clinical progression.

Unsurprisingly, the men with intermediate-risk disease had lower rates of overall and prostate cancer-specific survival than the men with low-risk disease:

  • Average (median) follow-up was
    • 6.9 years for intermediate-risk patients
    • 6.4 years for low-risk patients
  • 145/237 (61.2 percent) of the intermediate-risk patients were > 70 years of age.
  • 86/237 (36.3 percent) of the intermediate-risk patients received treatment (mainly radiation).
  • The median treatment-free interval for intermediate-risk patients was 12.3 years (range, 10.1 to 19.8 years).
  • 33/86 intermediate-risk patients who received treatment developed biochemical failure.
  • 17/86 intermediate-risk patients who received treatment developed metastatic disease.
  • The 10-year overall survival rates were
    • 68.4 percent for intermediate-risk patients
    • 83.6 percent for low-risk patients
  • The 15-year overall survival rates were
    • 50.3 percent for intermediate-risk patients
    • 68.8 percent for low-risk patients
  • The 10-year prostate cancer-specific survival rates were
    • 95.5 percent for intermediate-risk patients
    • 98.2 percent for low-risk patients
  • The 15-year prostate cancer-specific survival rates were
    • 88.5 percent for intermediate-risk patients
    • 96.3 percent for low-risk patients
  • The hazard ratios for intermediate- as compared to low-risk patients were
    • 2.08 for overall survival
    • 3.75 for prostate cancer-specific survival
  • The 10-year metastasis-free survival rate for intermediate-risk patients was 92.1 percent.
  • The 10-year treatment-free survival rate for intermediate-risk patients was 58.5 percent.

As the authors correctly conclude:

AS for intermediate risk prostate has significantly lower [overall survival] and [prostate cancer-specific survival rates] compared to low risk patients and therefore extreme caution should be exercised if it were to be implemented in intermediate risk patients.

However, it is worth noting that if you look at the differences in absolute as opposed to relative rates of all the measures used in this study, just as a couple of examples:

  • The absolute difference in prostate cancer-specific survival rates between the intermediate- and low-risk patients at 10 years is just 2.7 percent.
  • The absolute difference in prostate cancer-specific survival rates between the intermediate- and low-risk patients at 15 years is just 7.8 percent.

While these difference are certainly statistically significant, they are still small (especially when you consider that the men with intermediate-risk disease were mostly > 70 years of age at diagnosis). Furthermore, more than half of the intermediate-risk patients were able to avoid any treatment for 10 years.

It is very clear that exactly which patients with intermediate-risk prostate cancer are good candidates for active surveillance is an issue that is still in evolution. On the other hand, The “New” Prostate Cancer InfoLink would respectfully suggest that this report from the Sunnybrook group actually helps to confirm that active surveillance may be a highly appropriate management option for some, carefully identified patients with (favorable) intermediate-risk disease (but probably not all such men).

It should be borne in mind (yet again) that for many men with favorable intermediate-risk prostate cancer, the potential to avoid metastasis and risks associated with treatment for 10+ years (when one is already 65 years of age or more) may significantly outweigh a small increase in one’s risk for prostate cancer-specific death at 15 years. These are very personal decisions. Men need to be told about these options and given the relevant facts. It should not be assumed that all men necessarily value extent of life over quality of life.

4 Responses

  1. A more useful question would have been how does the AS high-risk group compare to other high-risk treated patients.

    This study really should be titled; Is high risk really a higher risk than low risk? That answer is kind of obvious.

  2. Dear Mike H:

    There were no true “high-risk” patients included in the Sunnybrook series. I think what you may be implying when you say “high risk” is the unfavorable intermediate-risk patients. It seems highly likely to me that these are the patients who did worst.

  3. Sitemaster,

    Thank you for reviewing this paper and making a very clear statement regarding AS for intermediate risk prostate cancer.

    A lot of people will potentially be helped by your clarifying this issue and will want to tune in for further developments on this question.

  4. It would be insightful to learn how the Gleason 7s broke down into 3 + 4s and 4 + 3s, and whether there was a significant difference in results for the two groups. Also, but less significantly, whether the volume of disease identified in the biopsy was a factor. The abstract and other reviews of the research that I have read do not appear to address this.
    It goes without saying that any discussion of Gleason 7 disease requires more information.

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