Proton-beam therapy is being advocated by physicians at proton centers; however, despite the claims of fewer side effects, no valid evidence can validate these claims, and no evidence has suggested that it provides better outcomes than other forms of radiation. For now, it simply is not worth the higher cost. That leaves conservative therapy, radical prostatectomy, brachytherapy, and external radiation.
To date, no study has compared radiation with conservative therapy, although the ProtecT study in Great Britain may be able to provide some insight. To date, only two well-designed randomized, controlled trials have been reported. A Scandinavian trial of watchful waiting compared with radical prostatectomy found a 5.4% higher survival in the men undergoing surgery at 12 years. However, the difference in survival only applied to men younger than 65 years. This study contained few men with T1C disease, making it hard to broadly apply the results to men diagnosed in the United States.
The PIVOT trial primarily enrolled men with T1C disease and found a 2.9% higher survival in the surgery group, although it was not statistically significant. In subset analyses, a slightly higher overall survival occurred in the group receiving conservative therapy, but this too was not significant. Men with low-risk disease did not have any better survival with surgery.
As for surgery vs either method of radiation, no randomized study has compared these options. Therefore, they are reasonable to consider; however, it cannot be argued that one of these therapies is more effective in treating localized disease.
Clearly, more randomized studies are needed to further identify which patients benefit from definitive therapy and which men do not. Until then, doctors should provide a careful explanation of the pros and cons of the various options, so that they can help each patient make an appropriate choice that is right for them.
A trial looking at the use of 5-alpha reductase inhibitors yielded interesting results. Although the risk for prostate cancer decreased in men taking the drug, those who were found to have prostate cancer had a higher grade of cancer. Men who take these drugs should be counseled appropriately on these risks.
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