Clinical trial · Interventional
Robotic Athermal Nerve-Sparing Radical Prostatectomy
Prospective Single-Center Randomized Study of Robotic Athermal Nerve-Sparing Radical Prostatectomy: Laparoendoscopic Single-Site Versus Standard Approach
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Research Cancelled
Summary
Brief summary (as posted)
This randomized clinical trial compares a recently developed technique, called robotic laparoendoscopic single-site radical prostatectomy (R-LESS RP), to the current standard of robotic technique for prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) in treating patients with newly diagnosed, locally confined prostate cancer. Both procedures are types of robotic radical prostatectomy, or the robot-assisted removal of the prostate though a small incision in the belly. In the standard approach, 4-5 small (1-2 cm) incisions are made in the lower abdomen to allow the insertion of robotic instruments. In the R-LESS technique, all instruments are inserted through a single incision. R-LESS RP is less invasive than RALP and may leave a smaller scar and cause less pain.
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 |
|---|---|---|---|
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| robot-assisted laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (RALP)
- description
- Patients undergo standard RALP.
- interventionNames
- Procedure: robot-assisted laparoscopic surgery
- Other: laboratory biomarker analysis
- Other: quality-of-life assessment
- Other: questionnaire administration
- type
- EXPERIMENTAL
- label
- Arm II (R-LESS RP)
- description
- Patients undergo R-LESS RP.
- interventionNames
- Procedure: robot-assisted laparoscopic surgery
- Other: laboratory biomarker analysis
- Other: quality-of-life assessment
- Other: questionnaire administration
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a biopsy proven newly diagnosed locally confined, stage T1a, T2a or T2b prostate cancer * Judged by the study doctor to be a suitable candidate for a radical prostatectomy * Serum prostate specific antigen equal to or less than 10 ng/mL * Gleason score equal to or less than 7 * Life expectancy greater than 10 years * Prostate size on trans-rectal ultrasound (TRUS) measurement less than 50 grams * Favorable operative risk defined as American Society of Anesthesiology Score (ASA score) =\< 3 * Ability to understand and the willingness to sign a written informed consent document or have a surrogate with the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Patients with any prior pelvic surgery * Patients with prior history of pelvic fractures or hip replacement * Large pelvic or intra-abdominal masses * Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions) * Poor surgical risk (defined as American Society of Anesthesiology Score \> 3) * Active infection * Uncorrected coagulopathy * Body mass index equal to or greater than 35
References
Publications (0)
Data not yet available