FDA's Newest Testosterone Update | What Men Need to Know

With Dr. Abraham Morgentaler and Dr. Marianne Brandon

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In this episode, Dr. Brandon and Dr. Morgentaler talk about the FDA's groundbreaking testosterone label changes, the evolving evidence on testosterone therapy and prostate cancer, and how quality of life should factor into treatment decisions for men with advanced disease.

00:00 Listener Question Metastatic Prostate Cancer – Dr. Morgentaler explains whether testosterone or anabolic steroids may have a place in treating men with metastatic prostate cancer while preserving quality of life.

04:09 Testosterone Quality of Life Tradeoffs – The doctors discuss real patient stories and the difficult decision between maximizing survival and maintaining a meaningful quality of life.

12:46 FDA Label Update Testosterone – Dr. Morgentaler breaks down the FDA's landmark decision to update testosterone labeling based on modern scientific evidence.

18:51 Testosterone Myth Falls – Dr. Morgentaler reflects on his decades-long effort to challenge the belief that testosterone causes or fuels prostate cancer.

24:09 FDA Label Changes Explained – A detailed look at what the FDA removed, what remains on the label, and what the changes mean for doctors and patients.

28:42 What Still Needs Fixing – The conversation covers the remaining barriers to testosterone therapy, including outdated regulations and future research priorities.

Resources:
TRAVERSE Trial
Lincoff AM, et al.

Cardiovascular Safety of Testosterone-Replacement Therapy.
Testosterone Does Not Drive Prostate Cancer: Presenting the New Framework of Androgen Adequacy vs Inadequacy
Abraham Morgentaler, Abdulmaged M. Traish

Testosterone Therapy in Men With Metastatic Prostate Cancer
Abraham Morgentaler, Jonathan Krakowsky, et al. (the episode references this case series presented and later published by Morgentaler and colleagues)

Testosterone Therapy in Men With Biochemical Recurrence of Prostate Cancer
Abraham Morgentaler, et al. (same published case series included men with biochemical recurrence)

Bipolar Androgen Therapy (BAT)
Samuel R. Denmeade, Emmanuel S. Antonarakis, et al. (Johns Hopkins group that developed BAT)
Modified Bipolar Androgen Therapy (Modified BAT)

Abraham Morgentaler (protocol described by Dr. Morgentaler; not a widely recognized standalone published trial title)

#prostatecancertreatment #testosteronetherapy #fdadecisions