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Modified Radical Prostatectomy for Prostate Cancer

Phase 3
Recruiting
Led By Andrew Vickers, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will study whether removing lymph nodes helps prostate cancer patients whose scans do not show positive nodes.

Who is the study for?
This trial is for men aged 21 or older with prostate cancer who are scheduled for radical prostatectomy at MSKCC. It's open to those without positive lymph nodes on scans and no prior pelvic radiation therapy. The study includes patients regardless of whether they're eligible for both surgical modifications being tested.Check my eligibility
What is being tested?
The trial is testing the effects of different surgical techniques during radical prostatectomy, including lymph node dissection versus none, and the use of a hemostatic agent to control bleeding. Patients will be randomly assigned to receive one technique or not.See study design
What are the potential side effects?
Potential side effects may include complications from surgery such as bleeding, infection risk due to lymph node removal or non-removal, and reactions related to the hemostatic agent if used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 or older and scheduled for a specific prostate cancer surgery at MSKC.
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I am 21 or older and scheduled for prostate cancer surgery at MSKCC.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-reported hernia
Secondary outcome measures
To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates
urinary tract infection (UTI)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)Experimental Treatment1 Intervention
Group II: One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)Experimental Treatment1 Intervention
Group III: Lymphadenectomy vs. no lymphadenectomyExperimental Treatment1 Intervention
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.
Group IV: Hemostatic agent vs. no hemostatic agentExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,930 Previous Clinical Trials
594,778 Total Patients Enrolled
131 Trials studying Prostate Cancer
63,294 Patients Enrolled for Prostate Cancer
Andrew Vickers, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Lymph node template Clinical Trial Eligibility Overview. Trial Name: NCT01407263 — Phase 3
Prostate Cancer Research Study Groups: Hemostatic agent vs. no hemostatic agent, One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021), Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021), Lymphadenectomy vs. no lymphadenectomy
Prostate Cancer Clinical Trial 2023: Lymph node template Highlights & Side Effects. Trial Name: NCT01407263 — Phase 3
Lymph node template 2023 Treatment Timeline for Medical Study. Trial Name: NCT01407263 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to register for this clinical trial?

"The information available on clinicaltrials.gov does appear to show that this study is still looking for participants. This trial was created on July 1st, 2011 and was last updated March 7th, 2022. They are hoping to enroll 2600 people at 3 different locations."

Answered by AI

Does the Lymph node template have any negative side effects?

"Lymph node template procedures have been proven effective in prior clinical trials and have received a score of 3 for safety."

Answered by AI
~232 spots leftby Jul 2025