Trial of Modifications to Radical Prostatectomy

NCT01407263 | Active Not Recruiting Phase 3

• 1 other identifier: 11-096
• Study Type: interventional
• Target: 3,204
• Locations: 1 country
• Sites: 5

Brief Summary

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

Prostate Cancer

Keywords

radical prostatectomy; anastomotic suturing; lymph node dissection; 11-096

Outcome Measures

Primary Outcomes (1)

• Patient-reported hernia

  Patient-reported hernia is a routine assessment on post-operative questionnaires completed by prostate cancer patients at MSKCC. The questionnaire asks about hernia near the surgical scar and if there has been a need for surgical repair of the hernia.

  1 year

Secondary Outcomes (2)

• To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates

  2 years

• urinary tract infection (UTI)

  within 10 days

Study Arms (4)

Lymphadenectomy vs. no lymphadenectomy

EXPERIMENTAL

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.

Procedure: Lymph node template

Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)

EXPERIMENTAL

Procedure: Transverse versus vertical closure

One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)

EXPERIMENTAL

Drug: antibiotic prophylaxis

Hemostatic agent vs. no hemostatic agent

EXPERIMENTAL

Drug: Hemostatic Agent

Interventions

Lymph node template PROCEDURE

Inclusion of the external iliac, hypogastric and obturator fossa nodal groups in the template undergoing a Radical Prostatectomy. Modifying the template for lymph node dissection may lead to removal of additional affected nodes, reducing the chance of recurrence. .No lymph nodes will be removed in patients randomized to the no PLND arm.

Lymphadenectomy vs. no lymphadenectomy

Transverse versus vertical closure PROCEDURE

Transverse versus vertical closure of the port site incision

Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)

antibiotic prophylaxis DRUG

One vs. three days of antibiotic prophylaxis at catheter removal

One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)

Hemostatic Agent DRUG

For the patients randomized to routine indwelling HA agent use, the operating surgeon may choose to use either Surgicel™, Surgicel SNoW™, Arista™, FloSeal or surgeon's choice HA directed at the prostatic fossa, ligated dorsal vein complex, or neurovascular bundles. Because there is no standard HA or method of application, the surgeon will apply the HA according to the surgeon's experience and document both the HA used, and the location applied in the operative report. For patients randomized to no routine indwelling HA use, surgeons will only apply a HA if they are unable to achieve hemostasis using traditional means or feel it would be unsafe to complete the operation without using a HA for additional hemostasis. Providers in either arm may use HA as needed provided the intention is not to leave the HA indwelling.

Hemostatic agent vs. no hemostatic agent

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (5)

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Uniondale, New York, 11553, United States

Location

Related Publications (3)

• Touijer 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 DERIVED

• Gaffney 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 DERIVED

• Touijer 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 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Antibiotic Prophylaxis; Hemostasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Premedication; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Andrew Vickers, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 2, 2011
• Study Start: July 1, 2011
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (5)