TRAVERSE Trial Video Series: Prostate Safety Events

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What the TRAVERSE Trial did and did not show


At its core, the TRAVERSE Trial shows that TRT of middle-aged and older men with hypogonadism with a PSA <3.0 ng/mL, who had been screened carefully to exclude those at high risk of prostate cancer, is associated with low risk of high grade or any prostate cancer. Several caveats apply to this inference. First,
because the numbers and incidence of high grade or any prostate cancer in the two groups were very low, these data should not be interpreted to mean that the incidence was similar in the two groups. Second, even though TRAVERSE is among the longest and the largest trials of TRT, with 14,304 person -23 years of follow-up and an average follow-up duration of 33 months, carcinogens typically take a long period of time to cause cancer. Long-term differences in risk of prostate cancer in men receiving testosterone or placebo are unknown. Third, in line with American Urological Association/Society of Urologic Oncology (AUA/SUO) guidelines, an elevated PSA was repeated in all men prior to consideration of further evaluation (49,50). Additionally, men were provided access to a standardized informational video about the potential benefits and risks of prostate biopsy to ensure shared decision-making regarding their desire for further evaluation. These steps likely reduced the number of persons undergoing prostate biopsy. Fourth, prostate imaging or genetic testing studies were not performed as part of the evaluation; it is possible that the availability of these additional diagnostic studies could have changed the decision to perform prostate biopsy. Finally, men at increased risk of prostate cancer were excluded from the trial; the trial's findings do not apply to men at high risk of prostate cancer.
 
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