Wonderous survival data in low-risk men treated with ProstRCision

In a paper just published on line in the Journal of Urology, the authors demonstrate that, in a series of patients treated with brachytherapy and external beam radiation therapy (so-called ProstRCision) between 1984 and 2000, they obtained long-term, recurrence-free survival rates (with PSA levels of < 0.2 ng/ml), comparable to those achieved with surgery.

The problem is that, when you read the full paper, it becomes clear that Critz and his colleagues were (to a very large extent) selectively treating men with low-risk disease … many of whom may never have needed treatment at all, since most of them would have clearly met current guidelines for active surveillance. These are the same men in whom Dr. Walsh was able to achieve long-term, biochemical recurrence-free survival by radical prostatectomy at Johns Hopkins. Many of those men may never have needed treatment either.

The “New” Prostate Cancer InfoLink has always taken the position that many men with low-risk disease are at greater risk from the adverse effects of treatment than they ever would be from the clinical progression of their prostate cancer. Even today, we are only beginning to see the acceptance of this principle in the clinical management of prostate cancer.

The paper by Critz et al. purports to show that, after treatment with ProstRCision:

  • Cancer control, as defined by a post-treatment PSA of < 0.2 ng/ml, is durable, with no further recurrences between 15.5 and 25 years post-treatment.
  • At least 15 years of follow-up is needed to evaluate the effectiveness of any therapy for prostate cancer.
  • If a man’s PSA level is < 0.2 ng/ml at 15 years post-treatment, later recurrence is highly unlikely.

Given the criteria on which this study is based, we feel that Critz and his colleagues can certainly claim to have made their point. However, let’s look at some of the other data that are and are not presented in this study:

  • The actual median follow-up of the 3,117 men included in this study was 11.0 years (range 3 months to 26 years).
  • 2,259/3,117 men in the study (72.5 percent) had a PSA level of < 10 ng/ml at diagnosis.
  • 2,280/3,117 men in the study (73.1 percent) had a Gleason score of ≤ 6 at diagnosis.
  • 2,617/3,117 men in the study (84.0 percent) had a clinical stage  of T1c or T2a at diagnosis.
  • The estimated median overall survival rates for the men in this study were
    • 75 percent at 10 years
    • 73 percent at 15 years
    • 73 percent at 20 years
    • 73 percent at 25 years
  • The estimated median prostate cancer progression-free survival rates for the low-risk group men in this study were
    • 96 percent at 5 years
    • 93 percent at 10 years
    • 92 percent at 15 years
  • There is not a single reference to any of the side effects of treatment in the paper.

Our take away from this study is pretty straightforward. If you aggressively treat men with low-risk disease who may not even need treatment (with ProstRCision, surgery, or anything else), you surely will be able to obtain excellent cancer-specific survival data. However, such data without any discussion of the side effects and complications of treatment is medically and scientifically useless. The “New” Prostate Cancer InfoLink feels that it is high time the editors of the Journal of Urology (and other standard journals that report data on the treatment of prostate cancer) set guidance for their contributors clearly indicating that papers presenting survival data from case series and clinical trials without any supportive data on the side effects and complications of treatment will no longer be considered for publication.

If you look at the survival data published by Klotz and his colleagues from his series of men managed with active surveillance, you will note that (to date) they have very similar survival data to those just published by Critz et al. They also have few to no side effects from treatment … because they didn’t actually need treatment!

11 Responses

  1. “There is not a single reference to any of the side effects of treatment in the paper.”

    It’s criminal that these refereed scholarly journals will accept papers so lacking in such very basic information. The Journal of Urology is a twisted sham.

  2. Well done Sitemaster. It is tragic that so-called medical experts can, either by accident or design, so gravely mis-report their findings.

  3. I totally agree with Sitemaster’s comments.

    Fernando Premoli, MD, PhD

  4. I, for one, had brachytherapy and radiation in 2002, and had quite a few nasty side effects. This reduced my PSA to almost nil, but 3 years later the cancer was back in force!

  5. This is just another example of the why our health care costs are so high. We treat men who don’t need any treatment with two treatments that increase side effects without any evidence that patients getting one therapy alone would do worse. Please, someone — stop this nonsense!

  6. I totally agree with Sitemaster’s analysis. I have heard Critz’s ads hundreds of times. He is a mass marketer providing only a sound bite of how he can cure you. It’s all about quality of life and need for treatment. We need to get the truth out.

  7. Didn’t read the “Critz” paper. Did it specify ages, average or otherwise. of those involved in the treatments? Feel this factor would also have been of some significance as to prospective “active surveillance” methodology.

  8. Dear Mr. Monahan:

    Yes, the paper by Critz and his colleagues does give information about the ages of the patients treated, as follows: 996 (28.1%) were 60 years or younger; 1,714 (48.3%) were between 61 and 70 years of age; 836 (23.6%) were over 70 years of age. In addition, the paper states that 384 men (10.8%) were of “Black” race; the remaining 3,162 (89.2%) were “White.”

  9. Was there any mention of mortality from any of these patients?

  10. Dear Chris:

    There is no clear data in the paper about the actual all-cause or prostate cancer-specific mortality of the patients enrolled in this case series. What the paper does state is that the median overall survival of the patients from time of treatment is 16 years; that the median age at initiation of brachytherapy was 65 years; and that the median lifespan of the patients was therefore 81 years. This would certainly seem to imply, when taken in conjunction with the other data, is that most men in this case series did not die of prostate cancer.

  11. Ah yes, the late Don Cooley developed a view about ProstRCision and the data from the therapy many years ago. Having been a supporter of the therapy for many years – a poster boy in fact – he turned.

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