How to cite: Khera M. Controversies with Testosterone Therapy. Grand Rounds in Urology. February 2026. Accessed Oct 2026. https://grandroundsinurology.com/controversies-with-testosterone-therapy/
Summary
Mohit Khera, MD, MBA, MPH, Professor of Urology, Baylor College of Medicine, Houston, Texas, outlines three central controversies in testosterone therapy.
First, he reviews indications for treatment, noting that historical FDA labeling requires a defined medical condition associated with low testosterone. He explains that the 2015 FDA update removed “idiopathic” hypogonadism, effectively limiting on-label use. In contrast, professional guidelines require only consistently low testosterone levels with associated symptoms, creating a disconnect between regulatory labeling and clinical practice.
Second, Dr. Khera reframes testosterone in the context of prostate cancer. He presents testosterone as a biomarker associated with prostate cancer risk, progression during active surveillance, and biochemical recurrence after prostatectomy. Data discussed suggest that low testosterone levels are linked with higher rates of adverse pathology and recurrence. He proposes incorporating testosterone into clinical decision-making alongside existing tools such as prostate-specific antigen (PSA) and genomic classifiers. He also highlights the testosterone to PSA ratio as a potentially useful and low-cost diagnostic adjunct.
Dr. Khera further introduces bipolar androgen therapy, which involves cycling between supraphysiologic and castrate testosterone levels in men with metastatic disease. He reviews early data demonstrating PSA responses and outcomes comparable to those of standard therapies, with potential sequencing advantages when followed by androgen receptor-targeted treatment.
Finally, he addresses cardiovascular safety using data from the TRAVERSE trial. In this large randomized study of men with hypogonadism and elevated cardiovascular risk, testosterone therapy did not increase major adverse cardiovascular events compared with placebo. He also reports no increase in prostate cancer incidence or worsening lower urinary tract symptoms.
Dr. Khera emphasizes that testosterone therapy remains widely used off-label, may have an expanded role in prostate cancer management, and has not demonstrated increased cardiovascular or prostate risk in the presented data.
About the 45th Annual Ralph E. Hopkins Urology Seminar
The Annual Ralph E. Hopkins Urology Seminar, also known as the Jackson Hole Seminars, brings together distinguished urologists, clinical researchers, and thought leaders to share wisdom and experience that drives meaningful progress in patient care. Changes occur in medicine and urology on an almost daily basis, so it is imperative that the practicing urologist remains on the cutting edge. Urologists need to keep current on assessing, diagnosing, and treating urologic conditions in the clinical setting. The 45th meeting took place in 2026, focusing on urologic cancers, stone disease, urologic reconstruction, female urology, infertility, emerging surgical techniques, and general urology. 2026 also marked the meeting’s first-ever all-female speaker panel.
ABOUT THE AUTHOR
Mohit Khera, MD, MBA, MPH, is a Professor of Urology at Baylor College of Medicine in Houston, Texas, where he holds the F. Brantley Scott Chair in Urology. He additionally serves Baylor College as the Director of the Laboratory for Andrology Research at McNair Medical Institute and the Medical Director of the Executive Health Program. Dr. Khera specializes in male and female sexual dysfunction, men’s health, male infertility, sexual dysfunction, declining testosterone levels in aging men, and hormone replacement therapy. His research interests include studies on the efficacy of botulinum toxin type A in treating Peyronie’s disease, genetic and epigenetic studies of post-finasteride syndrome patients, and testosterone replacement therapy.
