- The proposed labeling change would allow testosterone therapy consideration in appropriately selected men with treated localized prostate cancer or on active surveillance, reversing a longstanding restriction not supported by available evidence.
- Because PSA production is androgen-dependent, clinicians should monitor both testosterone and PSA levels together in hypogonadal men with a prostate cancer history to avoid misinterpreting artificially low PSA values.
- The absence of long-term data on testosterone and prostate cancer risk should not be equated with evidence of harm; shared decision-making, baseline risk assessment, and continued PSA surveillance support responsible treatment of appropriately selected patients.
The FDA's proposed updates to testosterone replacement therapy labeling—which would narrow the prostate cancer contraindication to metastatic disease only, removing the broader warning against use in men with suspected prostate cancer1—represent a long-overdue alignment of regulatory language with the clinical evidence base, according to Helen L. Bernie, DO, MPH.
"This is huge—it's long overdue," Bernie said. "FDA labeling is finally beginning to catch up with the science that we've had for years." She characterized the outdated warnings as a source of unnecessary fear among both patients and clinicians that has led many men to be denied treatment that could meaningfully improve their quality of life and overall health. Bernie noted that testosterone functions as a biomarker of broader male health, and that low testosterone has been associated with higher all-cause mortality.
"This change is huge and very well needed," she said, while acknowledging the work is not complete. "Are we finished? No. There's still a whole lot more work to do."
The proposed narrowing of the prostate cancer contraindication directly addresses what Bernie described as the most common question she hears from patients: whether testosterone causes prostate cancer.
"Based on the available evidence, the answer is no," she said. For years, men successfully treated for localized prostate cancer with radical prostatectomy, radiation therapy, or active surveillance were told they could never receive testosterone therapy—a restriction Bernie said never aligned with the underlying data. Under the proposed labeling, appropriately selected men with treated localized prostate cancer, or select men on active surveillance, can be considered for testosterone therapy with shared decision-making and close follow-up.
Bernie raised a clinically important and frequently overlooked point about PSA monitoring in this context: PSA is an androgen-dependent molecule, meaning adequate testosterone is required for its production. In men with profound hypogonadism, PSA levels may appear artificially low—potentially masking the true extent of disease in a population where PSA is a primary surveillance tool.
"I believe it's important to know both the PSA and the testosterone levels so that you can appropriately follow these patients and interpret the results," she said. Treating testosterone deficiency while maintaining routine PSA surveillance, she argued, can actually improve the accuracy of long-term monitoring.
On the FDA's acknowledgment that existing studies may not have followed patients long enough to fully characterize long-term prostate cancer risk, Bernie was direct about how she frames that uncertainty for patients.
"The best available evidence does not show that testosterone therapy increases prostate cancer risk," she tells patients, while also disclosing that long-term data remain limited—a limitation common to many areas of medicine given that prostate cancer develops over many years.
"Uncertainty is not the same as evidence of harm," she said. Her approach is to obtain a baseline PSA, assess individual prostate cancer risk, initiate therapy when appropriate, and continue routine PSA surveillance alongside standard testosterone monitoring.
"The fear surrounding testosterone and prostate cancer is not warranted based on the available data that we have," Bernie said. "We have strong evidence we can safely treat appropriately selected men while continuing to do careful, long-term surveillance and monitoring."
REFERENCE
1. HHS announces requested updates to testosterone therapy product labels. News release. US Department of Health and Human Services. June 18, 2026. Accessed June 30, 2026. https://www.hhs.gov/press-room/fda-requests-updates-testosterone-therapy-labeling.html
