Impact of Testosterone Replacement Therapy on Functional and Oncological Outcomes Following Radical Prostatectomy (ENFORCE Study).
Diederik Baas, Joost van Drumpt, Lambertus Kiemeney...
https://pubmed.ncbi.nlm.nih.gov/40514343Actively Recruiting
Phase 3
Age: 18Years +
MALE
ID04833426
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
104 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 often occurs after radical prostatectomy (RP) for prostate cancer and can significantly affect quality of life. Testosterone levels naturally decline with age, and about 30% of men over 70 have testosterone deficiency (TD). This study evaluates the effects of testosterone replacement therapy (TRT) on sexual function and cancer outcomes in men with TD after RP for prostate cancer. Participants are randomly assigned to receive either a daily topical testosterone gel or a placebo gel starting within 8 weeks after RP. The treatment lasts for one year, with dosage adjustments possible based on clinical response. This phase 3 trial includes a one-year monitoring period for functional outcomes and an additional four years of follow-up to assess five-year biochemical recurrence-free survival. During the study, participants will have regular blood tests and complete online questionnaires over 24 months to assess sexual, urinary, and hormonal function. Researchers will measure changes in sexual function scores using the EPIC-26 questionnaire at 3, 12, and 24 months after RP, as well as urinary incontinence, hormonal function, and cancer recurrence rates over five years. Side effects and safety will be monitored throughout the study period.
CONDITIONS
Brief Title
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Men aged 18 years or older
- Histologically confirmed prostate cancer
- Scheduled for radical prostatectomy as primary treatment
- At least one-sided nerve-sparing procedure performed
- Non-metastatic disease based on nomograms or imaging
- Undetectable PSA level within six weeks following surgery
- Minimum preoperative sexual function score of 40 points on EPIC-26
- Testosterone deficiency defined by specific total and free testosterone levels measured twice with normal or elevated luteinising hormone
You will not qualify if you...
- Prior prostate cancer treatment such as hormone therapy, radiotherapy, or brachytherapy (active surveillance allowed)
- Previous use of testosterone therapy
- Pathological stage pT3b or pT4 in prostatectomy specimen
- Positive surgical margins with high ISUP grade (4 or 5)
- Metastatic lymph nodes if lymph node dissection was done
- History of male breast cancer or liver tumor
- Uncontrolled high blood pressure
- Contraindications for testosterone replacement therapy
- Allergy to components of testosterone or placebo gels
- Use of vitamin K antagonists
- Body mass index over 30 kg/m²
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 3 visits including blood samples before and within six weeks after surgery
Surgery
Duration - Up to 3 months from screening
Participants undergo radical prostatectomy as primary treatment for prostate cancer.
1 surgical procedure
Treatment
Duration - 1 year
Participants receive daily topical testosterone gel or placebo starting within 8 weeks after surgery for one year.
Daily application of gel with regular follow-up visits for monitoring
Follow-up
Duration - Up to 5 years after surgery
Participants are monitored for functional outcomes and biochemical recurrence for up to five years after surgery.
Regular visits and online questionnaires over 24 months; medical record review for up to 5 years
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
Loading map...
Research Team
J
Joost van Drumpt, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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