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

Prior treatment

• Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)
• Previous use of testosterone therapy for any reason
• Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen

Other illness

• History of male breast cancer or liver tumour
• Uncontrolled hypertension
• Allergy for components in TRT agent or placebo

Other

• Pathological stage pT3b or pT4 in the RP specimen
• Presence of metastatic lymph nodes if pelvic lymph node dissection was performed
• General contraindications for TRT
• Use of vitamin K antagonists
• Body mass index (BMI) \>30 kg/m²

• Men aged 18 years or older
• Histologically confirmed prostate cancer
• Radical prostatectomy performed as primary treatment
• At least one-sided nerve-sparing procedure performed
• Non-metastatic disease (cN0M0) based on the use of nomograms or imaging
• Undetectable PSA level (\<0.1 µg/l or unmeasurable according to local protocol) within six weeks following RP
• A preoperative minimal sexual function, defined as a score of 40 points or more (out of 100) for the EPIC-26 sexual function domain
• Testosterone deficiency, defined as total testosterone \<8 nmol/L, or total testosterone between 8-12 nmol/L with free testosterone \<225 pmol/L, measured on two separate occasions, with normal or elevated luteinising hormone (LH)