Limitations
high-grade prostate cancer, hypogonadism, prostate cancer, prostate
HYPOGONADISM, MALIGNANT NEOPLASMS, PROSTATE, EVENTS, PROSTATE CANCER
The trial has some limitations. These findings should not be applied to patients with known prostate cancer, those with higher PSA values, or men who do not have confirmed hypogonadism. Although the TRAVERSE study was longer than most other randomized clinical trials of TRT, carcinogens may require many years to induce malignant neoplasms. The trial’s structured evaluation of men after PSA testing did not include prostate imaging or other biomarker tests that may influence the decision to perform a biopsy. It is possible that shared decision-making played a role in lower rates of prostate biopsy; results could be different in a setting in which shared decision-making is not made available. Although the trial’s sample size is the largest of any randomized testosterone trials to date, the numbers and incidences of any prostate cancer and high-grade prostate cancer were low. Because of the small number of prostate cancer events, these findings should not be interpreted to imply that the risk of prostate cancer in the testosterone and placebo groups was similar. The trial’s findings indicate that in men with hypogonadism who were screened and monitored carefully using a structured protocol, the risk of high-grade or any prostate cancer and other prostate events is low. The trial’s findings do not apply to men at high risk of prostate cancer, who were excluded. Rates of study medication discontinuation and loss to follow-up were high, although not dissimilar from those in randomized trials in other symptomatic conditions