Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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."
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021) | Experimental |
| |
| One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021) | Experimental |
| |
| Hemostatic agent vs. no hemostatic agent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates | Biochemical recurrence is defined as any postoperative PSA of 0.2 ng / mL or higher, or treatment with hormones, radiotherapy or chemotherapy starting six months or more after radical prostatectomy. | 2 years |
Not provided
Inclusion Criteria:
Lymphadenectomy vs no lymphadenectomy:
Hemostatic agent vs. no hemostatic agent
Exclusion Criteria:
Lymphadenectomy vs no lymphadenectomy
Hemostatic agent vs. no hemostatic agent
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Vickers, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39472200 | Derived | 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. | |
| 39115122 |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019072 | Antibiotic Prophylaxis |
| D006487 | Hemostasis |
| ID | Term |
|---|---|
| D018890 | Chemoprevention |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011292 | Premedication |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Transverse versus vertical closure | Procedure | Transverse versus vertical closure of the port site incision |
|
| antibiotic prophylaxis | Drug | One vs. three days of antibiotic prophylaxis at catheter removal |
|
| 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. |
|
| urinary tract infection (UTI) |
urinary tract infection (UTI) within 10 days of catheter removal. We will use the CDC's definition of UTI: symptomatic UTI diagnosed in patients with positive urine cultures (≥100,000 microorganisms per cm3) and at least one of the following signs or symptoms with no other recognized cause: fever (>38oC), urgency, frequency, dysuria or suprapubic tenderness.50 UTI is routinely captured by clinical staff as a surgical complication. |
| within 10 days |
| Memorial Sloan Kettering Bergen (Consent Only) |
| Montvale |
| New Jersey |
| 07645 |
| United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) | Uniondale | New York | 11553 | United States |
| 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. |
| 33865797 | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001790 |
| Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |