This was a prospective trial (Clinical trials.gov # NCT03063125) aiming to prospectively enroll 25 men with no prior history of treatment for HG or other hormonal disorders, with a new diagnosis of non-metastatic bladder cancer, referred for RC. All patients had pre-operative total, free testosterone and luteinizing hormone (LH). These labs were then repeated on post-operative days 2, 3, 30, and 90. The threshold for normal total testosterone was defined as > 250 ng/dl.
25/25 patients had been enrolled and the trial had been closed, but the data were mature enough to present only on 9 patients, enrolled to the trial between March and September 2017. Mean patient age is 68.5 years (52-85). The mean pre-operative total testosterone was 247 ng/dl (range 50-496 ng/dl) and 6/9 (66.7%) patients had preoperative HG. Two patients had abnormal pre-operative LH levels (range 21-57 mIU/L). Testosterone decreased by a mean of 99 ng/dl between pre-op assessment and post-operative day 2 [95% CI 66.2, 131.8]. All 6 men who initially had HG remained below 250 ng/dl. Two men experienced a decrease in their testosterone levels, from an eugonadal state (347 ng/dl, 316 ng/dl) to hypogonadal state (213 ng/dl,192 ng/dl, respectively) by post-operative day 2. At 30 days post-op, the mean T level was 206 ng/dl. No patients had returned to their preoperative baseline levels and 8/9 (88.9%) had HG (range 40-356 ng/dl).
HG is prevalent in men undergoing RC. This trial demonstrates a pre- and 30 day post-operative HG prevalence of 66.7% and 88.9%, respectively. Furthermore, HG persisted beyond the immediate post-operative period. Consideration of treatment of peri-operative HG with correction to a eugonadal state may represent a therapeutic intervention aiming to reduce the morbidity associated with radical cystectomy. Clinical trial information: NCT03063125
Presented by: Woodson Smelser, University of Kansas
Co Authors: Eugene Lee, Ajay Nangia, Katherine Glavin, Jeffrey M. Holzbeierlein; University of Kansas, Kansas City, KS; University of Kansas Medical Center, Kansas City, KS; University of Kansas Department of Urology, Kansas City, KS
Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2018 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, February 8-10, 2018 - San Francisco, CA