Yesterday we suggested that we would have more to say about this study when we had read the full text of the article by Wilt et al. and the associated editorial by Thompson and Tangen. However, in all truth, others have really done this job for us, and there is little point in reinventing the wheel.
We refer the interested reader to a detailed commentary on the Medscape web site. Yes, you do have to register to read this, but the Medscape site is one we recommend for many reasons.
Everyone is going to put their own spin on the results of the PIVOT study. Yes, it was flawed because Americans couldn’t be successfully encouraged to enroll in a randomized trial of surgery vs. observation. The size of the trial was therefore lower than originally intended. However, there are at least two core pieces of information that come out of this trial to confirm the findings of others:
- For men with low-risk, early stage, localized prostate cancer who are > 65 years of age and have a life expectancy of not more than 15 years, observation (i.e., active monitoring) is now shown to be every bit as effective as (and a great deal safer than) radical prostatectomy.
- For men with low-risk, early stage, localized prostate cancer who are > 65 years of age and have a life expectancy of more than 15 years, it is arguable that observation (i.e., active monitoring) may be at least as good an option as radical prostatectomy.
The problem is that the PIVOT data are really limited to these two pieces of wisdom. If one is under 60 years of age, the PIVOT study tells you nothing. And if you you are 65-70 years of age and have intermediate or high-risk disease, it really doesn’t offer you much help either.
We are left waiting again … this time for data from the ProtecT study being carried out in the UK, which (hopefully) is large enough and will offer sufficiently compelling data to be able to give some really strong recommendations regarding the customary use of active monitoring as compared to surgery and radiation as first-line management approaches to early stage prostate cancer in men between 50 and 70 years of age.