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Claims of “new hope” with experimental prostate cancer therapy based on shaky one-person foundation

Theranostic drug personalizes prostate cancer imaging and therapy: Combined PET imaging and radionuclide therapy offers new hope for advanced prostate cancer

Our Review Summary

Cancer therapy word cloudThis news release reports on a paper presented at the 2015 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging on a radionuclide drug that could be used both for imaging and therapy in advanced prostate cancer. The drug works by targeting cells that produce a protein called prostate-specific membrane antigen and varying dosages can either be used for radio imaging or to target cancer cells. An initial trial of this drug yielded a drop in prostate-specific antigen (PSA) levels from 38.0 to 4.6 nanograms per milliliter. This result was verified by PET scan and computed tomography.

These results could certainly warrant a news release calling attention to this novel research. However, we thought the execution could have been handled more carefully. Our main concern with this release is the disparity between the language used — for example, the headline touts “new hope for advanced prostate cancer” — and the actual research, which is based on treatment of a single person resulting in a drop in PSA levels. The release takes five paragraphs to tell us that the study involved only one person; it omits important details about his treatment; and it didn’t mention how long he lived or if, indeed, he is still alive. That’s a flimsy foundation for anyone with advanced prostate cancer to base their hopes.

 

Why This Matters

The radionuclide drug described in this release can potentially be used to identify and treat metastatic prostate cancer — for which currently there are no curative treatments.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Nothing at all is said about the cost of this treatment either for imaging or treatment. Granted, the drug is in the very early stages of development, but that didn’t stop the release from claiming that the approach “personalizes cancer imaging and therapy,” “offers new hope for advanced prostate cancer,” and may have “a major impact.” If it’s not too early to make such bold statements, then it’s not too early, in our view, to give some idea of what this treatment might cost.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

We are told that PSA levels dropped from 38.0 to 4.6 nanograms per milliliter and that the result was verified by PET scan and computed tomography. But we have no information about the time period over which the PSA dropped, whether there were additional treatments, and whether PSA levels remained low (and for how long) — and whether the patient is still alive. In treating metastatic cancers, survival benefits are often quite short, e.g., the median survival benefit for sipuleucel (Provenge vaccine) was only 4 months. So we’d want some evidence that patients are living longer (and more than just one of them) before talking about “new hope” for this disease. We also disagree with the comment that “current clinical methods are not sensitive enough for detecting disease beyond the prostate.” Currently used radionuclide bone scans can readily detect metastatic disease.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

This is not really addressed — or addressable — given that only one patient has been treated. The release discusses previous drugs of this type that had problems, and mentions “adverse effects” associated with existing therapies. The suggestion is that this drug does not have those problems and would be a safer alternative to existing therapies. But there’s no way we can assess the safety of this approach based on results in only patient. So the release is incomplete and potentially misleading in its discussion on this point.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The clinical study involved only one person, a detail which the release takes too long to tell us about. And as noted above under “Benefits,” the release is also short on details regarding other aspects of this patient’s treatment. There is no information at all about how the study was done with the mice, on the number of test subjects in either imaging or therapy. While the animal data are not necessarily translatable, it would also be interesting to know more about the diagnostic performance in mice — sensitivity and specificity.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering here.  Prostate cancer is a reality and as more men are living longer, prostate cancer diagnoses increase.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

There is no mention of funding for this work, so it is difficult to determine if there is any conflict of interest.  Funding is listed in the abstract and fairly clearly shows that there is no conflict of interest, but that is impossible to tell from the release.

Does the news release compare the new approach with existing alternatives?

Satisfactory

Other attempts at creating this type of imaging/therapy drug are mentioned, and the fact that metastatic prostate cancer is currently difficult to control and has a poor prognosis implies that there are few successful alternatives. We’ll award a Satisfactory, although the release could have made it clearer that targeted therapies are only a subset of treatments for metastatic cancer — which also includes various chemotherapies and the Provenge vaccine.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

This release does eventually make it clear that only one patient has been tested, that this is very preliminary work and that the drug is not available.

Does the news release establish the true novelty of the approach?

Satisfactory

The story mentions that while this is not the first time a drug of this nature has been attempted, it is the first time that one has been developed that hopefully does not have serious side effects or other problems.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

There is too much frothy language in this release based on a study that involved only one patient. For example:

  • “New hope for advanced prostate cancer”
  •  “a significant step forward that could have a major impact”
  • “a watershed moment for prostate cancer theranostics”

We also wish the release had defined the word “theranostics,” which would have made it easier for readers to tell if this is, indeed, a “watershed moment” in that field.

Total Score: 4 of 10 Satisfactory

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