Formal comment from ASTRO on the results of the ProtecT trial

The following official statement was issued on September 15 by the American Society for Radiation Oncology (ASTRO):


In light of the findings from the Prostate Testing for Cancer and Treatment (ProtecT) trial published in the New England Journal of Medicine, the American Society for Radiation Oncology (ASTRO) would like to congratulate the authors and investigators for conceiving and completing a difficult clinical trial to randomize care for 2,664 men who volunteered to be a part of this study. Their paper emphasizes the importance of joint decision making between prostate cancer patients and their physicians when weighing treatment options for early stage disease. Findings from the ProtecT trial can help patients understand the full range of approaches to manage their disease, including the risks and benefits of active monitoring versus early treatment with radiation therapy (RT) or surgery.

Ten-year findings from the trial indicate that for men with early stage prostate cancer, there is no difference in mortality rates following active monitoring, surgery or RT, and moreover, that cancer-specific deaths at ten years following diagnosis averaged only one percent for all men enrolled in the trial.

Growth of the cancer outside of the prostate did vary between monitoring and treatment groups. Rates of both regional spread and distant metastases were significantly higher for men who were monitored rather than treated for their early stage disease. Progression did not vary, however, between the surgery and RT groups, although patients in the trial reported different side effects with each modality.

“These findings underscore the essential role of dialogue in treatment selection,” said ASTRO President David C. Beyer, MD, FASTRO. “Men with prostate cancer are all different, and the relative costs and benefits associated with the multiple options to treat it can vary substantially between individuals. The best treatment decisions for prostate cancer, or any cancer, take into consideration the specifics of each individual patient’s disease, expectations and preferences. These options can be confusing, and patients should always make these decisions after consultation with a radiation oncologist and urologist”

ASTRO, the American Urological Association (AUA) and the American Society for Clinical Oncology (ASCO) are currently developing updated guidelines for the management of clinically localized prostate cancer. The recommendations, which update a 2007 collaborative guideline issued by the societies, are scheduled for publication in mid-2017.

The “New” Prostate Cancer InfoLink considers this statement to be entirely appropriate based on the data, and we are delighted to see that ASTRO and the American Urological Association (AUA) will be issuing a badly needed, joint update to their guidelines on the management of clinically localized prostate cancer as a consequence! As yet we have seen no formal statement from the AUA.

2 Responses

  1. From MedPage today:

    “For today, we can conclude on the basis of level 1 evidence that PSA monitoring, as compared with treatment of early prostate cancer, leads to increased metastasis,” wrote Anthony V. D’Amico, MD, PhD, of Dana-Farber Cancer Institute in Boston. “Therefore, if a man wishes to avoid metastatic prostate cancer and the side effects of its treatment, monitoring should be considered only if he has life-shortening coexisting disease, such that his life expectancy is less than the 10-year median follow-up of the current study.”

  2. Dear Ted:

    It is unusal for me to disagree with Dr. D’Amico, but please see what I wrote in this original report. I find Dr. D’Amico’s analysis of the results of this trial to be highly misleading for a whole number of reasons (and so, apparently, do many other clinicians who have also commented on this trial or who I have spoken to directly).

    Just for starters, we know that up to 23% of the men in this trial who were randomized to active monitoring (about 125 men) would never have been put onto active surveillance if they were diagnosed today because their risk for progressive disease was too high to begin with. It is therefore unsurprising that these men would have been at higher risk for metastasis over a period of 10 years that the men who got treatment. This is a trial designed 20 years ago. Active surveillance as carried out today is very different from the standards being applied in the protocol for this trial that stopped enrolling patients more than 6 years ago.

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