In a University of Texas news release remarkably light on evidence, but heavy with superlatives, a novel technique to treat prostate cancer using gold nanoparticles is presented to the world. Two testimonials, one from the lead researcher testing this new approach and a single patient who underwent the procedure, cannot together purport to be a solid basis for judging the worthiness of this bit of new high tech wizardry. We know that other techniques to treat prostate cancer, including active surveillance, have varying levels of success but there is no sense how those compare to the gold nanoparticle approach.
A safer, less invasive way to treat prostate tumors would surely be welcomed yet only under a few important caveats: The new technique must come with reliable evidence that is is as effective and safer than current treatments, and be offered at a cost that is acceptable to patients and the medical community.
No discussion of cost, but one could imagine that a treatment made from gold is not likely to be inexpensive.
There are no data to speak of in this news release so no reliable discussion of benefits either.
The only harms discussed are those in relation to competing treatments.
Other than learning that this is a “small clinical trial,” the news release was remarkably void of any discussion of the quality of the data collected. It is impossible to judge the quality of evidence as discussed in the news release.
Given that this study is not yet complete (ClinicalTrials.gov lists a December 2018 completion date), there may be no evidence to report regarding either benefits or harms (other than the anecdote of one patient). Regardless, the primary outcome of this study is whether the gold nanoparticle therapy can ablate (or destroy tumors without removing them) prostate lesions at 3-month follow up. Thus, this study will not be providing practice-changing evidence. Furthermore, based on the enrollment criteria, many of the subjects would have low- to very-low risk prostate cancers — which are best managed with active surveillance. Consequently, the treatment could hardly be described as life-changing.
The release doesn’t engage in disease-mongering. Prostate cancer can be fatal for some men and this release does not exaggerate the dangers of prostate cancer, even though the release appears to downplay the concept of active surveillance which is a suitable option for many men.
The funder(s) of the study aren’t mentioned. We don’t know how heavily the lead researcher, his research center or partners, or even the patient could be conflicted with the company developing the technology. That information would have been very helpful.
We learn about other alternatives: “Treatment options have traditionally included radical prostatectomy, which is the removal of the prostate gland and some of the tissue around it, radiation therapy and cryotherapy, among others. These methods carry the potential to have a negative impact on urinary function and sexual performance.”
“The side effects of current prostate cancer treatments can be extremely traumatic. This new technology holds the potential to eliminate those life-altering effects, while still removing the cancer tissue and reducing hospital and recovery time.”
While this is useful information it is inadequate. Impotence and urinary incontinence are often the downstream consequences of prostate cancer treatment but how did the rates of these adverse effects compare to the gold nanoparticle treated group? We don’t know.
In addition, the other treatment methods also carry the potential of curing cancers. We can’t say the same for the new technology.
The release gives the sense that this new technique is very experimental, and being done inside the bounds of a trial, but that is never made very clear. The trial will enroll only 45 patients and the follow up (a repeat biopsy) is only for 3 months.
The novelty of this technique seems to be its major claim to relevance yet the description of its novelty barely passes muster. For example, we don’t learn if gold nanoparticle research is being done for other types of tumors or other types of conditions.
This news release is flush with unjustifiable language including describing gold nanoparticles as “tumor-seeking missiles on a mission to remove prostate cancer.” It would be nice to see a description of a cancer treatment that didn’t rely on military metaphors.
Also objectionable: “This procedure is the first in the world that is precise enough to potentially avoid negative ramifications like urinary incontinence or sexual impotency.” Really? What about active surveillance?
“This therapy could be life-changing….” True. But where is the evidence to justify that claim?
While patients are entitled to their own opinions and beliefs, the news release has some over-riding responsibility to offer context. The patient said: “I wasn’t afraid to try the most cutting-edge technology.” But the release could have explained that patients should always be aware that there are risks in participating in trials involving experimental treatments.