Status:
RECRUITING
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Lead Sponsor:
Canisius-Wilhelmina Hospital
Collaborating Sponsors:
Besins Healthcare
Conditions:
Prostatic Neoplasms
Hypogonadism
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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 ov...
Detailed Description
Rationale: Radical prostatectomy (RP) is currently the most common treatment for non-metastatic prostate cancer (PCa). Two frequent side effects of this procedure are urinary incontinence and erectile...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04833426
Start Date
December 12 2022
End Date
December 1 2029
Last Update
May 2 2025
Active Locations (10)
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1
Amsterdam UMC location VUmc
Amsterdam, Netherlands
2
Netherlands Cancer Institute
Amsterdam, Netherlands
3
Rijnstate
Arnhem, Netherlands
4
Catharina Hospital
Eindhoven, Netherlands