Hello. I am Dr Gerald Chodak, for Medscape. Today I want to address the role of active surveillance in men with intermediate-risk prostate cancer. Two recent reports address this matter.
Raldow and colleagues[1] evaluated outcomes of men with low-risk vs low-risk intermediate disease who had undergone brachytherapy at the Prostate Cancer Foundation of Chicago, with a median follow-up of nearly 7 years. The analysis found that overall survival and prostate cancer survival rates were similar between the groups. Low-risk intermediate disease was defined as having only one of the three possible parameters of risk: prostate-specific antigen (PSA) between 10 and 20 ng/mL; a Gleason score of 3 (primary grade) +4 (secondary, next most frequent pattern); or T1c (nonpalpable) with T2 (palpable) disease. In addition, in this series, men were required to have cancer in less than 50% of the cores involved. Again, that study found no significant difference in overall survival and prostate cancer survival rates, but the results are relatively short-term, with a median follow-up of less than 7 years.
The second study,[2] from a Canadian group, reports a large active surveillance series. They found that men with intermediate-risk prostate cancer had about a 3.5-fold greater risk of dying from prostate cancer than men with low-risk disease. In this cohort, intermediate disease was defined using a different set of criteria. Men could have more than one of those three possible parameters, or they could have been up to 70 years of age with a PSA of up to 15 ng/mL. The analysis did not define men with low-risk intermediate disease. Thus, this series found that prostate cancer mortality is indeed higher for men with intermediate-risk disease.
What Is the Take-Home Message?
Neither of the studies was randomized. How do we interpret the results, and what kind of message can we take home? It must be true that some men with intermediate-risk disease will do well with active surveillance. I say that for two reasons. First, if we look back at the PIVOT trial,[3] which included intermediate-risk disease in men who underwent surgery vs conservative therapy, the difference in survival was not statistically significant, at least at 12 years.
Second, we realize that many of the men who have a Gleason 3+3 on biopsy turn out to have 3+4 disease when the radical prostatectomy is performed. There is a level of undergrading, and yet those men with Gleason 3+3 disease apparently have a low risk of dying of their disease, by at least 10-12 years. Is that long enough follow-up? No, but it does raise the question: Could active surveillance be offered to a select group of men who have intermediate-risk disease? Whether we define it as having only one of the three usual risk parameters or define it on the basis of how much cancer is detected on the biopsy remains unclear, but it certainly seems that further information is needed to define the group of men who can do well with active surveillance.
The British ProtecT trial will soon come due. This trial will have randomly assigned men to the various therapies, and everyone will be looking to the outcomes of that study to help further define who might be a reasonable candidate for active surveillance. These two reports, however, raise the question of whether a select group of men with intermediate 3+4 Gleason score disease could be treated conservatively, at least at the outset.
I look forward to your comments. Thank you.
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Cite this: Active Surveillance OK in Intermediate-Risk Prostate Cancer? - Medscape - Mar 25, 2015.
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