Testosterone Therapy in Men after Radical Prostatectomy for Organ-Confined, Low-Intermediate Prostate Cancer - Beyond the Abstract

The administration of exogenous testosterone to men with testosterone deficiency who have undergone radical prostatectomy for prostate cancer remains controversial. We define the safety of exogenous testosterone therapy, specifically the biochemical recurrence rate, in men post-radical prostatectomy for a low-intermediate grade, organ-confined prostate cancer.

A Cox model was created for time to biochemical recurrence with testosterone use included as a time-dependent covariate, adjusted for age, pre-operative PSA, grade group at radical prostatectomy, and the presence of comorbidities. A landmark analysis was used: patients were included in the analysis if their last PSA in the 18 weeks post-operatively was undetectable and they had not had biochemical recurrence or been lost to follow-up by that point, and follow-up for biochemical recurrence began at 18 weeks. Biochemical recurrence was defined as a PSA ≥ 0.1 ng/mL post-radical prostatectomy with a second confirmatory rise ≥ 0.1 ng/mL.

We observed in a population study of 5,199 men post-radical prostatectomy, 5,001 not receiving testosterone therapy and 198 receiving testosterone therapy that in this carefully selected population of patients with organ-confined, grade group 1-3 prostate cancer treated after surgery, and we found a non-significantly decreased risk of biochemical recurrence associated with the use of testosterone after radical prostatectomy (HR 0.84, 95% CI 0.48, 1.46; p=0.5), and overall rates of biochemical recurrence were low, with probability of biochemical recurrence at five years less than 2% in both groups.

In this study, which included the largest sample size reported and the optimal methodology to analyze testosterone therapy in this selected group of men with organ-confined prostate cancer and grade groups 1 – 3 on surgical pathology, we found no evidence that testosterone therapy increases the risk of biochemical recurrence after surgery.

Written by: Jose M. Flores, MD, MHA, Sexual & Reproductive Medicine Program, Urology Service, Memorial Sloan Kettering Cancer Center, New York, NY

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