Actively Recruiting
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Led by Canisius-Wilhelmina Hospital · Updated on 2025-05-02
140
Participants Needed
10
Research Sites
363 weeks
Total Duration
On this page
Sponsors
C
Canisius-Wilhelmina Hospital
Lead Sponsor
B
Besins Healthcare
Collaborating Sponsor
AI-Summary
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).
CONDITIONS
Official Title
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 nomograms or imaging
- Undetectable PSA level (<0.1 g/l or unmeasurable) within six weeks following RP
- Preoperative minimal sexual function with EPIC-26 sexual function domain score of 40 or more
- Testosterone deficiency defined as total testosterone <8 nmol/L, or 8-12 nmol/L with free testosterone <225 pmol/L on two occasions with normal or elevated LH
You will not qualify if you...
- Prior prostate cancer treatment including anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)
- Previous use of testosterone therapy
- Pathological stage pT3b or pT4 in RP specimen
- Positive surgical margins with ISUP grade 4 or 5 in RP specimen
- Metastatic lymph nodes if pelvic lymph node dissection performed
- History of male breast cancer or liver tumor
- Uncontrolled hypertension
- General contraindications for TRT
- Allergy to components of TRT agent or placebo
- Use of vitamin K antagonists
- Body mass index (BMI) >30 kg/m
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Amsterdam UMC location VUmc
Amsterdam, Netherlands
Actively Recruiting
2
Netherlands Cancer Institute
Amsterdam, Netherlands
Actively Recruiting
3
Rijnstate
Arnhem, Netherlands
Actively Recruiting
4
Catharina Hospital
Eindhoven, Netherlands
Actively Recruiting
5
Treant
Emmen, Netherlands
Actively Recruiting
6
Zuyderland
Heerlen, Netherlands
Actively Recruiting
7
St. Antonius Hospital
Nieuwegein, Netherlands
Actively Recruiting
8
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands, 6532 SZ
Actively Recruiting
9
Radboud university medical center
Nijmegen, Netherlands
Actively Recruiting
10
Máxima Medical Centre
Veldhoven, Netherlands
Actively Recruiting
Research Team
J
Joost van Drumpt, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here