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

Launched by CANISIUS-WILHELMINA HOSPITAL · Apr 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of testosterone replacement therapy (TRT) in men who have undergone radical prostatectomy (RP) for prostate cancer and have low testosterone levels. The goal is to see if TRT can improve sexual function and overall health after surgery, as sexual dysfunction is a common issue following RP and can greatly affect a man's quality of life. The trial is specifically looking at men aged 65 to 74 who have certain criteria, including having low PSA levels after surgery and a score of 40 or higher on a sexual function questionnaire.

To participate in the trial, men must have had a successful RP, meaning no signs of cancer spread and certain other health conditions. They will receive testosterone therapy and be monitored for changes in their sexual function and overall health. It's important to note that those with advanced cancer, previous testosterone treatments, or certain medical conditions will not be eligible. This trial is currently recruiting participants, aiming to help improve the lives of men facing the challenges of low testosterone after prostate surgery.

Gender

MALE

Eligibility criteria

• • Inclusion criteria
• • 1. Men aged 18 years or older
• • 2. Histologically confirmed prostate cancer
• • 3. Radical prostatectomy performed as primary treatment
• • 4. At least one-sided nerve-sparing procedure performed
• • 5. Non-metastatic disease (cN0M0) based on the use of nomograms or imaging
• • 6. Undetectable PSA level (\<0.1 µg/l or unmeasurable according to local protocol) within six weeks following RP
• • 7. A preoperative minimal sexual function, defined as a score of 40 points or more (out of 100) for the EPIC-26 sexual function domain
• • 8. 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)
• • Exclusion criteria
• • 1. Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)
• • 2. Previous use of testosterone therapy for any reason
• • 3. Pathological stage pT3b or pT4 in the RP specimen
• • 4. Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen
• • 5. Presence of metastatic lymph nodes if pelvic lymph node dissection was performed
• • 6. History of male breast cancer or liver tumour
• • 7. Uncontrolled hypertension
• • 8. General contraindications for TRT
• • 9. Allergy for components in TRT agent or placebo
• • 10. Use of vitamin K antagonists
• • 11. Body mass index (BMI) \>30 kg/m²