Impact of Testosterone Replacement Therapy on Functional and Oncological Outcomes Following Radical Prostatectomy...

Area of Science:

• Urology
• Endocrinology
• Oncology

Background:

• Testosterone deficiency (TD) affects 18-38% of men post-radical prostatectomy (RP).
• Testosterone replacement therapy (TRT) is presumed safe and effective for sexual function post-RP, but evidence is limited.
• The ENFORCE study aims to evaluate TRT's impact on sexual recovery and oncological safety after RP.

Purpose of the Study:

• To assess the efficacy of TRT in improving sexual function recovery in men with TD after RP.
• To determine the oncological safety of TRT concerning biochemical recurrence (BCR) following RP.
• To evaluate the effects of TRT on quality of life, and hormonal and urinary function post-RP.

Main Methods:

• Phase 3, multicentre, randomised, single-blind, placebo-controlled trial (ENFORCE study).
• Recruitment of men with TD undergoing RP, with minimal preserved erectile function.
• Randomisation to TRT or placebo from 6-12 weeks post-RP until 1 year, with follow-up to 60 months for BCR.

Main Results:

• Primary endpoint: sexual function at 12 months (EPIC-26 sexual domain).
• Secondary endpoints: sexual function at 6 and 24 months, quality of life, hormonal and urinary function.
• Biochemical recurrence (BCR) assessed at 12, 24, and 60 months.

Conclusions:

• The ENFORCE trial will provide robust data on TRT's benefits and safety post-RP.
• Results may clarify the role of TRT in managing sexual dysfunction and recurrence risk in prostate cancer survivors.
• This study addresses a critical gap in evidence regarding TRT use after radical prostatectomy.