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Modified Radical Prostatectomy for Prostate Cancer

Phase 3

Waitlist Available

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

Be older than 18 years old

Must not have

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 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: No additional exclusion criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a scan showing abnormal pelvic nodes or received pelvic radiation for prostate cancer.

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I am not excluded by my choice of hemostatic agent use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-reported hernia

Secondary study objectives

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

urinary tract infection (UTI)

Awards & Highlights

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.

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

0 / 2Eligibility criteria met