Clinical trial · Interventional
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypogonadism | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Testosterone Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Testosterone gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Testosterone therapy
- description
- Daily application of two pump auctions of 16.2mg/ml testosterone gel. Dosage may be altered depending on clinical response
- interventionNames
- Drug: Testosterone gel
- type
- PLACEBO_COMPARATOR
- label
- Placebo therapy
- description
- Daily application of two pump auctions of placebo gel.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Clinically relevant (≥12 points) difference in the EPIC-26 sexual functioning domain score, 12 months after radical prostatectomy between groups.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBaas D, van Drumpt J, Kiemeney L, Beck J, Ostergren PB, Sedelaar M, Hoekstra R, Spruyt AB, van Melick H, Bruins M, van Leeuwen P, Vis A, Wijburg C, Roelofs L, van den Bergh R, van Soest R, van Basten JP, Somford D. Impact of Testosterone Replacement Therapy on Functional and Oncological Outcomes Following Radical Prostatectomy (ENFORCE Study). Eur Urol Oncol. 2026 Apr;9(2):479-486. doi: 10.1016/j.euo.2025.05.024. Epub 2025 Jun 12. PMID 40514343