These were just some of the issues that jumped out at our reviewers from this news release about a study published in the journal Urology. The study evaluated treatment of 20 men with prostate cancer that had metastasized, or spread to other parts of the body.
All of the patients received a combination of pharmaceutical, surgical and radiation treatment with the end goal of having no detectable prostate cancer after 20 months.
The release did an adequate job in describing the study’s novelty and the availability of the different treatment options.
But the headline and opening paragraphs of the release frame the research as a potential “cure” for metastatic prostate cancer, despite concerns, that the release itself notes, about the fact that this is a small, preliminary study in which cancer ultimately appears to have recurred for all of the “successful” patients. Lastly, the release notes that the design of the study allowed researchers to identify which combination of treatments was most effective at eliminating detectable disease.
Prostate cancer is extremely common, with the National Cancer Institute reporting that prostate cancer makes up 9.6 percent of new cancer cases each year. And 5 percent of those prostate cancers are diagnosed only after the cancer has metastasized.
Is this an automatic death sentence? No. Patients with metastatic prostate cancer can live for years with the disease — something the release does not mention. (According to SEER data managed by the National Cancer Institute’s Surveillance Research Program service, the 5-year survival for metastatic prostate cancer is 29 percent.)
Instead, the release focuses on the fact that, to date, metastatic prostate cancer has been considered incurable — which is true. However, the release seems to waffle in how it presents these new findings: in some places it treats the findings as evidence that the disease can be cured, and elsewhere it offers a much more guarded optimism, saying that the work means researchers should at least try to cure metastatic prostate cancer. Given the amount of uncertainty involved in a study of this size, the release should have focused on the latter approach.
We want to emphasize: this is important research with intriguing findings. But the way the findings are communicated in this news release leaves much room for improvement, and we try to point out some of those opportunities with constructive criticism.
Costs are not discussed at all. Given the scope of the treatments, we think it’s important for a release like this to at least give some cost estimates. It’s also unclear from the release whether insurance would cover these treatment plans. The study noted that one patient could not complete the protocol due to lack of insurance coverage.
The benefit here was the elimination of detectable prostate cancer within 20 months of beginning drug treatment. The release makes clear that four of the 20 patients in the study reached this endpoint. But there are some problems. For one thing, the release notes that, of the four patients who reached the relevant endpoint, the cancer “remained undetectable in two patients for 27 and 46 months, respectively.” What happened after 27 and 46 months? Was the cancer detected again? Or was that simply when researchers submitted the paper? And what happened to the other two patients? According to the journal manuscript, the cancer remained undetectable for the other two patients for five and six months, respectively. But, again, it’s not clear if the cancer then came back or if that was simply when the study ended. Given that the entire release hangs on whether people still have prostate cancer, this should be crystal clear to readers — and it’s not. In addition, it would have been very easy to include the numbers for all four patients who reached the endpoint, so this looks like cherry-picking. Lastly, it’s worth noting that the benefit was not clearly defined until the sixth paragraph. Since this was the defined endpoint for the study, the release would have been stronger if it had noted this earlier.
In addition, the 20 month time period strikes us as arbitrary for a study endpoint. Typically, when oncologists speak of cure it implies that there is no evidence of disease five years after treatment. An undetectable PSA is a surrogate measure and we do not know whether the multiple treatment approach can “cure” cancer or even extend survival. The longer-term follow-up data (which was variable in length because patients were not enrolled at the same time), indicated that two of the four patients did have not have recurrence of the cancer (at least based on detectable PSA). However, this seems to imply that two of the patients could have had recurrence after 20 months.
The release doesn’t mention harms at all – except to say that the combo treatment was “well tolerated.” Given that the patients received a combination of drugs, surgery and radiation treatment, there are a host of potential side effects. We don’t expect a release like this one to provide an exhaustive list of those potential harms, but we do expect it to acknowledge possible side effects in some sort of meaningful way. Readers have no way of knowing what “well tolerated” means in the absence of more facts.
Granted, the published study offered very little observation in the way of harms. But in the absence of such information we encourage news release authors and journalists to seek clarification since it’s a key consideration for people considering treatment options.
The release makes clear that this study is “only a first step,” and clearly describes the study — including the fact that it involved only 20 patients. The release would have been stronger if it had noted the amount of uncertainty inherent in any study involving such a small number of people — the study had almost as many authors as patients! The release would have been improved had it noted more directly that this is a small, uncontrolled study, with carefully selected patients.
The release focuses on the fact that metastatic prostate cancer has been considered incurable. That’s true. And it’s true that metastatic prostate cancer is often fatal. But it’s also true that patients with metastatic prostate cancer can live with the disease for 5, 10 or 15 years — or longer.
While the release doesn’t disease monger per se, it does “treatment monger” by over-hyping the benefit of the tested treatment approach and implying in several instances that this is a cure for metastatic prostate cancer. This small pilot study didn’t show that.
The release doesn’t mention who funded the work or whether there were any conflicts of interest.
The release notes that the results of the three-pronged treatment approach were better than would have been achieved with any of the treatment options on their own. However, it doesn’t provide evidence for this statement. Because the treatment was offered to a small, highly-selected group of patients and the study did not have a control group, the validity of this claim is uncertain.
The release makes clear that all of the treatment options are currently available.
The release does a good job of articulating how this work takes a three-pronged approach and promotes the idea of working toward a means of curing metastatic prostate cancer. It would have been stronger if it had offered more discussion regarding the importance of “a new paradigm for testing various drug combinations in conjunction with local treatment of the prostate to determine which is the best approach (ie, has the highest undetectable disease rate).” That seems like a useful tool for both researchers and clinicians, and is largely glossed over.
The subhed, or secondary headline, for the release states that “a new paradigm including drug therapy, surgery, and radiation may cure previously incurable cancer.” And the first sentence of the release says: “In the past, all forms of metastatic prostate cancer have been considered incurable.” (Emphasis added.) But lower down, the release notes that this study “is only a first step,” that “Longer follow-up is needed to determine whether these patients were in fact cured” and that “the longevity of effect is essential to prove the point of curability.” In other words, this is a small study that absolutely can’t prove whether a cure is possible. It’s a promising first step, but it is only a first step — and should be approached with cautious language. Using cautious language later in the release doesn’t make up for over-reaching language at the top.
The author is quoted in the news release as saying that “the endpoint also shifts the paradigm from palliation to cure,” a comment that goes beyond the data. The study does not provide sufficient data to know whether the three-pronged treatment can “cure” cancer. Therefore, we don’t know whether the surrogate endpoint is clinically meaningful.