Clinical trial · Interventional
HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
NCT03802851CI-TRIAL-00117811HOLEP-RTPCrecruitingN/AClinicalTrials.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)
To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) and/or urinary retention alters the treatment course for patients concurrently diagnosed with prostate cancer.
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 |
|---|---|---|---|
| Lower Urinary Tract Symptoms | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Holmium Laser Enucleation of Prostate (HoLEP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Holmium Laser Enucleation of Prostate (HoLEP)
- description
- Patients in this arm will undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS). Patients will undergo HoLEP one time and will return for standard of care follow up.
- interventionNames
- Procedure: Holmium Laser Enucleation of Prostate (HoLEP)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Patients in this arm will undergo no additional interventions and will not undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms and instead follow standard of care treatment and follow up.
Primary outcomes (2)
- measure
- Improvement in Quality of Life - One Year Post Operatively
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be 18 years of age or older * Patients must have bothersome lower urinary tract symptoms (LUTS), defined by American Urological Association Symptom Score (AUA SS) of greater than or equal to 15 and/or as defined by a post-void residual of greater than or equal to 350mL and/or as defined by catheter dependence * Patients must be diagnosed with prostate cancer by pathological tissue analysis * Patients must have elected for radiation with androgen deprivation therapy as the primary treatment modality for their prostate cancer Exclusion Criteria: * Patients who are under 18 years of age are not eligible * Patients who have a diagnosis of bladder cancer are not eligible. * Patients with prior treatment for prostate cancer are not eligible. * Patients with any type of prior prostate surgery (minimally invasive, endoscopic, or otherwise) including prior transurethral resection of the prostate (but excluding prior prostate biopsy) are ineligible. * Patients with known metastatic prostate cancer are ineligible * Patients who are enrolled in other surgical or international trials at the time of this study are not eligible
References
Publications (0)
Data not yet available
No reference posted for this study.