Testosterone and Cardiovascular Risk: TRAVERSE Trial and New FDA Label Change
Mohit Khera, MD, MBA, MPH, discusses testosterone therapy and cardiovascular risk, focusing on the TRAVERSE trial and FDA label changes.
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Mohit Khera
Panel Discussion: Men’s Health, Andrology, and Infertility
Mohit Khera, MD, MBA, MPH; Brian S. Christine, MD
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Changing Paradigm in the Diagnosis Band Management of Erectile Dysfunction
Mohit Khera, MD, MBA, MPH, Professor of Urology and Director of the Laboratory for Andrology Research at the McNair Medical Institute at Baylor College of Medicine, identifies the paradigm shifts presented in 2018 guidelines for erectile dysfunction (ED), and the current landscape of treating these patients with regenerative therapies.
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TRAVERSE Trial Update
Mohit Khera, MD, MBA, MPH, presents the latest updates from the TRAVERSE Trial, examining the cardiovascular effects of testosterone therapy. This presentation is an update to Dr. Khera’s “Results from the TRAVERSE Trial” lecture, which was presented to the Grand Rounds in Urology audience in August 2023.
Dr. Khera begins by reviewing the history of the TRAVERSE Trial and its initial results regarding the impact of testosterone therapy on cardiovascular health. He outlines the design of the TRAVERSE Trial, which concluded in January 2024 with a final enrollment count of 5,246 men.
In addition to the original secondary and tertiary endpoints regarding cardiovascular safety and prostate safety, Dr. Khera discusses other secondary endpoints in the trial. These endpoints were sexual function, depression, bone fractures, diabetes, and anemia.
Dr. Khera concludes by delving into the final results of testosterone therapy on all endpoints in the trial. He notes that the results indicate that testosterone therapy does not significantly worsen BPH symptoms and may protect against the development of anemia. However, he notes that testosterone therapy may raise the risk of bone fractures and pulmonary embolisms.
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Testosterone to Improve the Diagnosis and Treatment of Prostate Cancer
Mohit Khera, MD, MBA, MPH, explores how testosterone can help diagnose and treat prostate cancer. He explains that low testosterone is a biomarker for prostate cancer, a predictor of who will progress on active surveillance (AS), and a risk factor for biochemical recurrence after prostatectomy. Further, testosterone therapy can be a treatment for metastatic prostate cancer.
Dr. Khera argues that while testosterone should not be considered a monotherapy, it can augment treatment. He explains PSA has poor sensitivity and addresses biomarker tests that seek to improve sensitivity and specificity. Dr. Khera asserts the ratio of testosterone to PSA has sensitivity of 82 percent and specificity of 62 percent, with lower costs than biomarker tests. He cites data explaining for men with low testosterone, PSA alone may not be accurate. Dr. Khera cites another study on testosterone as a predictor of upstaging and upgrading in low-risk AS patients. It concludes testosterone should be a selection criterion for inclusion of low-risk prostate cancer patients in AS programs.
Dr. Khera explains lower preoperative testosterone levels increase the risk for prostate cancer recurrence. Dr. Khera turns to treatment options, looking at bipolar androgen therapy (BAT) that includes patients with advanced disease receiving high doses of testosterone which results in a 50 percent reduction in both PSA and metastatic disease. Dr. Khera cites a study on BAT for asymptomatic men with castration-resistant prostate cancer; the BAT was well-tolerated and resulted in high response rates.
Dr. Khera cites the TRANSFORMER study comparing BAT vs. enzalutamide. Data show no difference in survival; however, patients who switched from BAT to enzalutamide had the highest survival rates. Dr. Khera concludes that testosterone can improve prostate cancer diagnosis and counseling for patients on biochemical recurrence; it comes with significantly less cost and offers greater quality of life.
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