This news release from the University of Missouri Medical School summarizes an observational study of 364 men with re-occurring prostate cancer after radiation who had a complex surgery involving complete removal of their prostate and surrounding tissue. The news release noted that the majority of men were still alive 10 and 20 years after the surgery, called “salvage” prostatectomy. We found this news release missed some criteria we find important such as cost and harms. It reported that surgery-after-radiation increased a man’s chances of survival but the news release provides no support for that claim–and neither does the study. In addition, we looked for data on cancer-specific survival, which presumably is the point of providing a second cancer treatment, but found none.
Men with prostate cancer face a bewildering range of choices in treatment, and not much clear advice on the best course. Medicine has not discovered a foolproof way to predict whether a man’s cancer is mild, moderate or aggressive. This new study suggests that some patients who avoid surgery and choose radiation first but then suffer a recurrence of cancer may benefit from salvage prostatectomy after radiation.
The news release does not mention costs.
The news release adequately quantifies the benefits with this statement:
“Using the Surveillance, Epidemiology and End Results (SEER) program database, Pokala and his research team studied 364 patients who underwent a salvage radical prostatectomy surgery after unsuccessful radiation treatments. Looking at survival rates, the researchers found that 88.6 percent of men were still alive 10 years later and 72.7 percent of men were still alive 20 years later.”
It would have been beneficial to readers if the release had also included cancer-specific survival. Without a comparison group, it’s hard to draw any conclusions about the benefit of this approach. Even if there was a comparison, it’s also hard to draw conclusions from observational data. While they could report how many patients were alive at the end of the study period only a relatively small proportion of the patients would have been followed for the 20 years so it would be hard to interpret.
The news release does not mention or explain any harms that might be associated with these surgeries. This strikes us as especially disappointing because some of the side effects of surgery are known to influence patient decisions about treatment. The two side effects that get the most attention are incontinence and impotence.
The researcher is quoted acknowledging the fear that patients have, but does not offer any measures for post-surgical outcomes related to quality of life. We found that disappointing.
“Because radical prostatectomy is a complex surgery, there can be a reluctance to undergo the procedure,” Pokala said. “However, this study shows that it is a viable treatment option. This can bring a renewed hope and peace of mind to men living with prostate cancer.”
Harms for either surgery or radiation alone such as urinary, bowel, and sexual dysfunction, can adversely affect quality of life. The literature suggests that salvage prostatectomy can cause even more worrisome complications such as damage to pelvic structures, blood clots, and bleeding. Unfortunately, these data are not available in the SEER database so the authors could not assess–an important limitation of the study.
There are several limitations on the evidence and that carries over to the news release. First, this release is focused on a study that relied on observational data as opposed to a randomized controlled trial so it is inappropriate to use cause -effect statements such as “improves survival.” In addition, subjects included in the analysis had undergone salvage treatments between 1988 and 2010. The problem with this is that radiation technologies have changed a lot since then. Today physicians are able to order higher radiation doses with fewer complications — and studies have shown that men with high-risk cancers should receive hormone therapy in addition to radiation (and the authors cited lack of data on hormone therapy as a limitation of their analyses). Surgical techniques have also changed — most procedures are now being performed laparoscopically with robots. Basically, we don’t know how applicable the results are for a man facing a treatment decision in 2016.
There’s no mention of who funded the study or if there were potential conflicts of interest in the release. The journal article stated there were no conflicts of interest.
The release did not include information on what alternatives patients may have chosen who suffered recurrence after radiation, but did not elect to have the prostatectomy. However, we’ll give them the benefit of a doubt since there are no clinical trials comparing options such as cryotherapy, surgery and brachytherapy.
Data analyzed in the release relates to surgeries performed between 1988 and 2010 at many different institutions so we assume it is widely available.
The release doesn’t make any claim to novelty and that’s appropriate because it’s understood that the surgery in question has been performed since at least 1988.
The news release did not use unjustifiable language.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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