📃 Paper Title: Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism A Randomized Clinical Trial
🧍 Author: Bhasin
🕒 Year: 2023
📚 Journal: JAMA - Journal of American Medical Association (JAMA Network)
🌎 Country: United States
ㅤContext to the study:
Is there evidence to support the safety of Testosterone Replacement Therapy -TRT in hypogonadal men with high-grade prostate cancer?
Does testosterone replacement therapy in men with hypogonadism increase the risk of high-grade prostate cancer or other adverse prostate events?
ㅤ✅ Take-home message of study:
TRT was associated with a greater increase in PSA levels than placebo. However, the risk of prostate cancer, including high-grade disease, was not increased.
ㅤ Placebo-controlled, double-blind randomized clinical trial
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Study participants:
Incluion criteria: 5246 men (aged 45-80 years) from 316 US trial sites who had 2 testosterone concentrations less than 300 ng/dL, hypogonadal symptoms, and cardiovascular disease (CVD) or increased CVD risk. Exclusion criteria: Men with prostate-specific antigen (PSA) concentrations greater than 3.0 ng/mL and International Prostate Symptom Score (IPSS) greater than 19 were excluded
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Key study outcomes:
Primary Outcomes: incidence of adjudicated high-grade prostate cancer - during 14 304 person-years of follow-up, there were 5 participants with high-grade prostate cancer in the TRT group and 3 in the placebo group. The incidence of high-grade prostate cancer did not differ significantly between groups (5 of 2596 [0.19%] in the TRT group vs 3 of 2602 [0.12%] in the placebo group; hazard ratio, 1.62; 95% CI, 0.39-6.77; P = .51). Secondary Outcomes: Secondary end points included incidence of any adjudicated prostate cancer, acute urinary retention, invasive prostate surgical procedure, prostate biopsy, and new pharmacologic treatment.
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Study 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. The trial's findings do not apply to men at high risk of prostate cancer, who were excluded.
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What were the rates of prostate cancer across study arms?
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