Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Recruiting · NCT04833426 · Interventional (participants receive a specific treatment) · Lead sponsor: Canisius-Wilhelmina Hospital
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboTestosterone gel
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
- Pathological stage pT3b or pT4 in the RP specimen
- Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen
- Presence of metastatic lymph nodes if pelvic lymph node dissection was performed
- History of male breast cancer or liver tumour
- Uncontrolled hypertension
- General contraindications for TRT
- Allergy for components in TRT agent or placebo
- Use of vitamin K antagonists
- Body mass index (BMI) \>30 kg/m²
Where it is running
10 locations listed.
- Amsterdam UMC location VUmc - Amsterdam, Netherlands
- Netherlands Cancer Institute - Amsterdam, Netherlands
- Rijnstate - Arnhem, Netherlands
- Catharina Hospital - Eindhoven, Netherlands
- Treant - Emmen, Netherlands
- Zuyderland - Heerlen, Netherlands
- St. Antonius Hospital - Nieuwegein, Netherlands
- Canisius Wilhelmina Ziekenhuis - Nijmegen, Netherlands
- Radboud university medical center - Nijmegen, Netherlands
- Máxima Medical Centre - Veldhoven, Netherlands