THE "NEW" PROSTATE CANCER INFOLINK

A new paper in the Journal of Urology provides data from European males with clinically low levels of serum testosterone indicating that, in these patients, testosterone replacement therapy (TRT) was not associated with any increase in risk for a diagnosis of prostate cancer.

Clearly, this is a good thing for hypogonadal men with no history of prostate cancer who need TRT. However, what this study does not demonstrate is whether there is or is not increased (or decreased) risk very specifically for

• Recurrence of prostate cancer among men who use TRT because they are hypogonadal after apparently successful treatment for prostate cancer
• Diagnosis of prostate cancer among men who use TRT but who do not meet standard criteria for hypogonadism

Of the 1,023 men enrolled in the three independent registry databases used to conduct the current analysis, none at all had been diagnosed and treated for prostate cancer prior to enrollment in this study.

Here are the overall study data from the paper by Haider et al.:

• Data was extracted from three independent, parallel, prospective, ongoing, registry studies.
• 1,023 men were enrolled in these three registries and received TRT if they met both of these criteria:
  • Their total serum testosterone level was ≤ 350 ng/dl (≤ 12.1 nmol/l).
  • They had clear symptoms of hypogonadism.
• Patients were followed for a maximum of 17 years and an average (median) of 5 years.
• Patients ranged in age from 15 to 84 years.
• All patients were treated using injections of testosterone undecanoate at 12-week intervals.
• All patients received a pretreatment examination of the prostate and monitoring during treatment.
• Prostate biopsies were performed (according to EAU guidelines) on 92/1,023 patients (9.0 percent) during the follow-up period.
• 11/1,023 patients (1.1 percent) were diagnosed with prostate cancer.
• The rate of prostate cancer diagnosis in this cohort of men appears to be significantly lower than the rates of diagnosis observed in the major prostate cancer screening trials reported to date.

The authors conclude that:

Testosterone therapy in hypogonadal men does not increase the risk of prostate cancer. If guidelines for testosterone therapy are properly applied, testosterone treatment is safe in hypogonadal men.

This seems to be an entirely reasonable conclusion. However, in the discussion section of their paper (as also reported on the ScienceDaily web site) the authors state that:

In view of the current evidence, clinicians … cannot justify withholding T therapy from hypogonadal men and men who have been successfully treated for [prostate cancer].

Whether this is a justifiable statement is almost certainly going to be a much more hotly debated matter. For The “New” Prostate Cancer InfoLink, it is not a justifiable statement because there were no patients at all included in this study who were hypogonadal as a direct consequence of a diagnosis of prostate cancer and its treatment. While this study certainly appears to demonstrate that TRT presents little or no increase in risk for a diagnosis of prostate cancer among a wide range of hypogonadal males who have never been diagnosed and treated for prostate cancer prior to their initial use of TRT, expanding the study’s conclusions to include a specific set of patients who were not even represented in the trial appears (at least to us) to be — at best — a stretch, and a long stretch at that.

We want to be extremely clear that The “New” Prostate Cancer InfoLink does not have a problem with individual prostate cancer patients, after appropriate discussion with their doctors, deciding that they will take the known (and the unknown) risks associated with TRT in an attempt to optimize their vitality and sexual functionality. That is a personal choice and the available clinical data about the levels of risk remain unclear. Some physicians will feel able to support this decision; others will be willing to go along with it, even though they don’t think it is a good idea; and some physicians will probably still think that the decision is unjustifiable and won’t write the prescription. However, Haider et al. have provided no data in this study that justify the idea that TRT has no impact on risk for prostate cancer recurrence in men who are hypogonadal as a consequence of treatment for prostate cancer. In our opinion, to draw such a conclusion based on this study is an error of judgment.

Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: hypogonadism, replacement, testosterone, TRT |