Testosterone gel after prostate removal surgery in men with low testosterone
Tests testosterone gel against placebo in men with prostate cancer and low testosterone.
Plain-language title generated from the registry record
Registry title: Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Key facts
- Where
- Amsterdam, Arnhem, Eindhoven, Emmen, Heerlen, Nieuwegein, Nijmegen, and Veldhoven, NetherlandsSee the 10 sites
- Phase
- Phase 3
Where in Netherlands
- Amsterdam UMC location VUmcAmsterdam, NetherlandsTaking people
- Netherlands Cancer InstituteAmsterdam, NetherlandsTaking people
- RijnstateArnhem, NetherlandsTaking people
- Catharina hospitalEindhoven, NetherlandsTaking people
- TreantEmmen, NetherlandsTaking people
- ZuyderlandHeerlen, NetherlandsTaking people
- St. Antonius HospitalNieuwegein, NetherlandsTaking people
- Canisius Wilhelmina ZiekenhuisNijmegen, NetherlandsTaking people
- Radboud University Medical CenterNijmegen, NetherlandsTaking people
- Maxima Medical CentreVeldhoven, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Canisius-Wilhelmina Hospital
- Trial code
- NCT04833426
- Record updated
- 2 May 2025
- Original description
Sexual dysfunction is a common side effect of radical prostatectomy (RP) and has a significant negative impact on quality of life. With age the testosterone level in men declines; around 30% of men over 70 years of age meet the criteria of testosterone deficiency (TD). The negative impact of both TD and RP on sexual performance are likely to add up. The aim of this study is to assess the efficacy and safety of testosterone replacement therapy (TRT) on functional and oncological outcomes in testosterone deficient men following RP for prostate cancer (PCa).Read full original descriptionShow less
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Sexual dysfunction is a common side effect of radical prostatectomy (RP) and has a significant negative impact on quality of life. With age the testosterone level in men declines; around 30% of men over 70 years of age meet the criteria of testosterone deficiency (TD). The negative impact of both TD and RP on sexual performance are likely to add up. The aim of this study is to assess the efficacy and safety of testosterone replacement therapy (TRT) on functional and oncological outcomes in testosterone deficient men following RP for prostate cancer (PCa).
Inclusion: 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).
Exclusion: 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; History of male breast cancer or liver tumour; Uncontrolled hypertension; Allergy for components in TRT agent or placebo; 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.