Clinical trial · Interventional
Transurethral Prostate Enucleation in Surveillance Protocol for Low Risk Prostate Cancer
Anatomical Endoscopic Enucleation of the Prostate for Treatment of Bladder Outlet Obstruction in Patients With Low-risk Prostate Cancer on Surveillance Protocol, Prospective Assessment of Functional and Oncological Outcome
NCT05631080CI-TRIAL-00062415unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
We will compare oncological and functional outcomes of anatomical endoscopic enucleation of the prostate (AEEP) versus continued medical treatment in low-risk prostate cancer patients for whom an active surveillance protocol was selected.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Outlet Obstruction | — | UNRESOLVED | — |
| Prostate Cancer Stage I | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anatomical Endoscpic enucleation of the Prostate | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Surveillance with medical treatment for bladder outlet obstruction
- description
- Patients with low-risk prostate cancer who were elected for active surveillance protocol will have only medical treatment for control of their lower urinary tract symptoms secondary to bladder outlet obstruction
- type
- ACTIVE_COMPARATOR
- label
- Surveillance with anatomical endoscopic enucleation of the prostate for bladder outlet obstruction
- description
- Patients with low-risk prostate cancer who were elected for active surveillance protocol will be offered anatomical endoscopic enucleation of the prostate for control of their lower urinary tract symptoms secondary to bladder outlet obstruction
- interventionNames
- Procedure: Anatomical Endoscpic enucleation of the Prostate
Primary outcomes (2)
- measure
- PSA progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Life expectancy \>/= 10 years 2. Low risk prostate cancer with minor institutional amendment of EAU guidelines: * PSA \< 10 ng/ml or up to 20 ng/ml if PSA density is more than 15% * Stage T1, T2a. * Gleason score \<7 (ISUP grade 1) 3. Bladder outlet obstruction: * IPSS \> 9 * Peak flow rate (Qmax \< 15) * Imperative indication for BOO surgery Exclusion criteria: * Patients who are not willing * Patients with bladder dysfunction (cystopathy) or other infravesical cause of obstruction other than prostate
References
Publications (0)
Data not yet available
No reference posted for this study.