Now what about treatment for this disease?
Now what about treatment for this disease? Well, hopefully we have progressed a little bit from this “voice-mail” answer for patients a few years ago. Once again, there are a number of different ways to treat this disease. There are some patients that don’t need to be treated. There are no randomized studies that compare treatment to no treatment. The standard in the United States though, for organ-confined prostate cancer, remains a radical prostatectomy and different forms of radiation therapy remain an alternative, and in general a quality of life alternative. Hormonal therapy could be used in some patients and cryosurgery as well.
Now how do people do with treatment? Well, we can say something about their likelihood of being cured. There are now two large studies, one from the Cleveland Clinic and one from our institution, looking at the comparison – this is not randomized data, but controlled retrospective data looking at different factors at baseline – and looking at the comparison of external beam radiation to surgery. What one can say is that no matter what one does with localized prostate cancer, the likelihood of being alive at five years is good and equivalent between both of these different types of treatment. And the same can be said at 10 years as well. The outcome appears to be similar with surgery and with radiation in these retrospective, non-randomized types of studies. What the outcomes will look like at 15 and 20 years after treatment remains to be seen. Another thing that we can tell patients is something about the morbidity of treatment. So we can tell people the likelihood of being cured, we can tell people the morbidity of different treatments – we have some good data there – what we cannot tell people is what is their need to be treated. That remains largely unknown. This is a study that we did. This is the only prospective study that looked at treatment outcomes after radiation and surgery in which questionnaires were given to the patients prior to treatment as well as after treatment. The leader of the study was Jim Calcott in our group. We are only looking at radical prostatectomy and external beam radiation here. When asked the question of whether the patients are developing urinary incontinence, radiation does not cause urinary incontinence where surgery does. Fully one-third of individuals two years after having a radical prostatectomy were still wearing absorptive pads because of concern of leakage or true leakage. And 13% of men said that they had a lot of incontinence. One of the disappointing findings in this is that sexual dysfunction was very high with either form of therapy. With radical prostatectomy the majority of patients were rendered impotent as a result of surgery, by the definition of inadequate erections for sex. It really did not matter whether or not they had the nerve-sparing procedure. It is only the subset of individuals who had bilateral nerve-sparing procedures, who were relatively young, where the results were reasonably high. About 50% of those individuals maintained potency. Radiation has its problems as well, although radiation does not cause immediate impotence, it does cause comparable levels of impotence which occurs slowly over a several-year period of time.
An issue that comes up in the treatment of early prostate cancer in under-staging. This is best illustrated, I think, from this paper that was published in JAMA a few years ago. Once again, out of the SERE cancer registry looking at 3,000 men who had undergone a radical prostatectomy in the late 80’s, early 90’s. The important finding here is that over one-third of patients who were treated with radical prostatectomy required some other form of therapy within the next five years; either hormonal therapy or radiation therapy because they had relapsed or there was some concern of relapse. So what had become popular 5-10 years ago were strategies to combine hormonal therapy with either surgery or radiation to try to improve the cure rates of these particular forms of local therapy. In the context of surgery, there were three randomized studies comparing surgery to preoperative hormonal therapy followed by surgery. In these studies hormonal therapy was given for a short amount of time, generally three months. In all the studies there was a reduction in the likelihood of having positive margins when hormonal therapy was used, but no difference in disease free or overall survival. So at the present time, preoperative hormonal therapy is not the standard of care. Now it may be that this concept is completely flawed, or alternatively one requires longer term hormonal therapy in order to see an effect in relapse and overall survival. But that remains unanswered.