Testosterone Replacement Therapy Effects on Sexual and Cancer Outcomes After Radical Prostatectomy in Men with Low Testosterone

What this Trial Is About

Sexual dysfunction often occurs after radical prostatectomy RP for prostate cancer and can significantly affect quality of life. Testosterone levels naturally decline with age, and about 30% of men over 70 have testosterone deficiency TD. This study evaluates the effects of testosterone replacement therapy TRT on sexual function and cancer outcomes in men with TD after RP for prostate cancer. Participants are randomly assigned to receive either a daily topical testosterone gel or a placebo gel starting within 8 weeks after RP. The treatment lasts for one year, with dosage adjustments possible based on clinical response. This phase 3 trial includes a one-year monitoring period for functional outcomes and an additional four years of follow-up to assess five-year biochemical recurrence-free survival. During the study, participants will have regular blood tests and complete online questionnaires over 24 months to assess sexual, urinary, and hormonal function. Researchers will measure changes in sexual function scores using the EPIC-26 questionnaire at 3, 12, and 24 months after RP, as well as urinary incontinence, hormonal function, and cancer recurrence rates over five years. Side effects and safety will be monitored throughout the study period.

Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy