Last reviewed · How we verify
NCT04833426: ENFORCE
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Phase 3 trial testing Testosterone gel in Prostatic Neoplasms in 140 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | Canisius-Wilhelmina Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 12 December 2022 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 December 2029 |
| Sites | 10 locations across Netherlands |
Drugs / interventions tested
- Testosterone gel
- Placebo
Conditions studied
- Prostatic Neoplasms — all drugs for Prostatic Neoplasms →
- Hypogonadism — all drugs for Hypogonadism →
- Testosterone Deficiency — all drugs for Testosterone Deficiency →
Sponsor
Canisius-Wilhelmina Hospital
Who can join
18 and older, male only, with Prostatic Neoplasms or Hypogonadism. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Clinically relevant (≥12 points) difference in the EPIC-26 sexual functioning domain score, 12 months after radical prostatectomy between groups.
Time frame: 12 months
Functional recovery after radical prostatectomy will be assessed by EPIC-26 questionnaire, a Patient Reported Outcome Measure (PROM). Patients will be asked to complete this questionnaire online.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Impact of Testosterone Replacement Therapy on Functional and Oncological Outcomes Following Radical Prostatectomy (ENFORCE Study).
Baas D, van Drumpt J, Kiemeney L, Beck J, et al · · 2026 · PMID 40514343 · DOI 10.1016/j.euo.2025.05.024
Verify or expand the search:
- PubMed search for NCT04833426
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Testosterone gel
Trials testing the same drug.
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- NCT06294990 — Klinefelter Syndrome and Testosterone Treatment in Puberty · Phase 4 · recruiting
- NCT06253702 — Brain Blood Flow Responses to Stress: Sex Differences · Phase 4 · completed
- NCT05586802 — Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome · Phase 3 · recruiting
- NCT04831099 — Testosterone Treatment in a Patient With 17β-hydroxysteroid Dehydrogenase Type 3 Deficiency: an N-of-1 Study · Phase 3 · unknown
Other recruiting trials for Prostatic Neoplasms
Currently open trials in the same condition.
- NCT07285057 — Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance · Phase 2 · recruiting
- NCT07319871 — A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer · Phase 1 · recruiting
- NCT07335224 — Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture · NA · recruiting
- NCT07451002 — A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France · recruiting
- NCT06547398 — Prostate Adaptive Radiation Therapy · NA · recruiting
Other Canisius-Wilhelmina Hospital trials
Trials by the same sponsor.
- NCT06282185 — SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy · NA · withdrawn
- NCT07202286 — Comparing Physician and Artificial Intelligence Chatbot Responses to Frequently Asked Questions From Osteoarthritis Pati · completed
- NCT06227806 — Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome · NA · unknown
- NCT05272904 — The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery · NA · unknown
- NCT05000827 — Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04833426 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Canisius-Wilhelmina Hospital
- Last refreshed: 1 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04833426.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing