Your session is about to expire
← Back to Search
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 belowSelect...
I am 21 or older and scheduled for a specific prostate cancer surgery at MSKC.
Select...
I am 21 or older and scheduled for prostate cancer surgery at MSKCC.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 21 or older and scheduled for a specific prostate cancer surgery at MSKC.I am 21 or older and scheduled for prostate cancer surgery at MSKCC.I have had a scan showing abnormal pelvic nodes or received pelvic radiation for prostate cancer.You don't have to meet both requirements to participate in the study.I am not excluded by my choice of hemostatic agent use.
Research Study Groups:
This trial has the following groups:- Group 1: Hemostatic agent vs. no hemostatic agent
- Group 2: One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)
- Group 3: Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)
- Group 4: Lymphadenectomy vs. no lymphadenectomy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Share this study with friends
Copy Link
Messenger