A Randomized Trial of Modifications to Radical Prostatectomy

Who is this study for? Patients 21 years or older scheduled for radical prostatectomy for treatment of prostate cancer
Status: Active_not_recruiting
Location: See all (5) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge
Memorial Sloan Kettering Bergen (Consent Only)
Montvale
New York
Memorial Sloan Kettering Westchester
Harrison
Memorial Sloan Kettering Cancer Center
New York
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale
Time Frame
Start Date: 2011-07
Completion Date: 2026-07
Participants
Target number of participants: 3204
Treatments
Experimental: Lymphadenectomy vs. no lymphadenectomy
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.
Experimental: 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
Authors
Andrew Vickers
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov