Clinical trial · Interventional
Trial of Modifications to Radical Prostatectomy
A Randomized Trial of Modifications to Radical Prostatectomy
NCT01407263CI-TRIAL-00122197active not recruitingPhase 3ClinicalTrials.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)
This trial will evaluate whether the following aspect of surgical technique influence outcome: Lymph node dissection. In some patients, scans taken before surgery show that a lymph node has cancer. Surgeons make sure to remove those affect lymph nodes and all other lymph nodes in the area. However, it is not known whether removing lymph nodes helps prostate cancer patients whose scans do not show positive nodes. In this study, patients with clear scans will either receive a lymph node dissection or not."
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antibiotic prophylaxis | Drug | — | UNRESOLVED |
| Hemostatic Agent | Drug | — | UNRESOLVED |
| Lymph node template | Procedure | — | UNRESOLVED |
| Transverse versus vertical closure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Lymphadenectomy vs. no lymphadenectomy
- description
- In patients randomized to standard, only the nodal packet under the external iliac vein and above the obturator nerve will be dissected. For patients randomized to the modified template, the external iliac, hypogastric and obturator fossa nodal groups will be removed.No lymph nodes will be removed in patients randomized to the no PLND arm.
- interventionNames
- Procedure: Lymph node template
- type
- EXPERIMENTAL
- label
- Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)
- interventionNames
- Procedure: Transverse versus vertical closure
- type
- EXPERIMENTAL
- label
- One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients do not have to be eligible for both modifications to be included in the study. Lymphadenectomy vs no lymphadenectomy: * Patients 21 years or older scheduled for radical prostatectomy for treatment of prostate cancer with one of the consenting surgeons at MSKCC Hemostatic agent vs. no hemostatic agent * Patients 21 years or older scheduled for minimally invasive radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKC Exclusion Criteria: Lymphadenectomy vs no lymphadenectomy * Presence of positive/suspicious pelvic nodes on MRI, CT or PSMA scan (positive/suspicious defined as a pelvic node \>15mm in short axis on CT or MRI, a PSMA avid node, or a node with abnormal morphology such as roundness or irregularity or loss of fatty hilum) * Any prior pelvic radiation therapy used to treat prostate cancer Hemostatic agent vs. no hemostatic agent * No additional exclusion criteria
References
Publications (3)
- DERIVEDTouijer KA, Vertosick EA, Sjoberg DD, Liso N, Nalavenkata S, Melao B, Laudone VP, Ehdaie B, Carver B, Eastham JA, Scardino PT, Vickers AJ. Pelvic Lymph Node Dissection in Prostate Cancer: Update from a Randomized Clinical Trial of Limited Versus Extended Dissection. Eur Urol. 2025 Feb;87(2):253-260. doi: 10.1016/j.eururo.2024.10.006. Epub 2024 Oct 29. PMID 39472200
- DERIVEDGaffney CD, Vertosick EA, Laudone V, Goh AC, Carlsson SV, Pietzak E, Donahue T, Smith R, Touijer K, Vickers AJ, Ehdaie B. Randomized Trial of Transverse vs Vertical Extraction Site Incision After Robotic Radical Prostatectomy. J Urol. 2024 Sep;212(3):401-408. doi: 10.1097/JU.0000000000004066. Epub 2024 Aug 8. PMID 39115122
- DERIVEDTouijer KA, Sjoberg DD, Benfante N, Laudone VP, Ehdaie B, Eastham JA, Scardino PT, Vickers A. Limited versus Extended Pelvic Lymph Node Dissection for Prostate Cancer: A Randomized Clinical Trial. Eur Urol Oncol. 2021 Aug;4(4):532-539. doi: 10.1016/j.euo.2021.03.006. Epub 2021 Apr 15. PMID 33865797