Effect of testosterone therapy on outcomes after prostate surgery
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
This study is testing if testosterone therapy can help men with low testosterone feel better and improve their quality of life after prostate cancer surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Canisius-Wilhelmina Hospital Academic / other |
| Locations | 10 sites (Amsterdam and 9 other locations) |
| Trial ID | NCT04833426 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of testosterone replacement therapy (TRT) on functional and oncological outcomes in men with testosterone deficiency who are undergoing radical prostatectomy for prostate cancer. The study is a phase 3, randomized, placebo-controlled trial that will assess the efficacy and safety of TRT in improving sexual function and quality of life post-surgery. Participants will be screened for testosterone levels before and after the surgery to determine eligibility and monitor outcomes. The trial aims to provide insights into how TRT can mitigate the negative effects of both testosterone deficiency and prostate surgery.
Who should consider this trial
Good fit: Ideal candidates are men over 18 years old with non-metastatic prostate cancer scheduled for radical prostatectomy and diagnosed with testosterone deficiency.
Not a fit: Patients who have previously undergone prostate cancer treatment or have used testosterone therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve sexual function and quality of life for men undergoing prostate surgery.
How similar studies have performed: Other studies have shown promising results with testosterone therapy in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Men aged 18 years or older 2. Histologically confirmed prostate cancer 3. Radical prostatectomy performed as primary treatment 4. At least one-sided nerve-sparing procedure performed 5. Non-metastatic disease (cN0M0) based on the use of nomograms or imaging 6. Undetectable PSA level (\<0.1 µg/l or unmeasurable according to local protocol) within six weeks following RP 7. A preoperative minimal sexual function, defined as a score of 40 points or more (out of 100) for the EPIC-26 sexual function domain 8. 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 1. Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed) 2. Previous use of testosterone therapy for any reason 3. Pathological stage pT3b or pT4 in the RP specimen 4. Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen 5. Presence of metastatic lymph nodes if pelvic lymph node dissection was performed 6. History of male breast cancer or liver tumour 7. Uncontrolled hypertension 8. General contraindications for TRT 9. Allergy for components in TRT agent or placebo 10. Use of vitamin K antagonists 11. Body mass index (BMI) \>30 kg/m²
Where this trial is running
Amsterdam and 9 other locations
- Amsterdam UMC location VUmc — Amsterdam, Netherlands (Recruiting)
- Netherlands Cancer Institute — Amsterdam, Netherlands (Recruiting)
- Rijnstate — Arnhem, Netherlands (Recruiting)
- Catharina Hospital — Eindhoven, Netherlands (Recruiting)
- Treant — Emmen, Netherlands (Recruiting)
- Zuyderland — Heerlen, Netherlands (Recruiting)
- St. Antonius Hospital — Nieuwegein, Netherlands (Recruiting)
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands (Recruiting)
- Radboud university medical center — Nijmegen, Netherlands (Recruiting)
- Máxima Medical Centre — Veldhoven, Netherlands (Recruiting)
Study contacts
- Principal investigator: Diederik Somford, MD, PhD — Canisius-Wilhelmina Hospital
- Study coordinator: Joost van Drumpt, MSc
- Email: enforce@cwz.nl
- Phone: +31243658190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.