Trial of Modifications to Radical Prostatectomy
Study Details
Study Description
Brief 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."
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
Procedure: Lymph node template
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.
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Experimental: Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)
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Procedure: Transverse versus vertical closure
Transverse versus vertical closure of the port site incision
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Experimental: One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)
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Drug: antibiotic prophylaxis
One vs. three days of antibiotic prophylaxis at catheter removal
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Outcome Measures
Primary Outcome Measures
- Patient-reported hernia [1 year]
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.
Secondary Outcome Measures
- To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates [2 years]
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.
- urinary tract infection (UTI) [within 10 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
Lymphadenectomy vs no lymphadenectomy
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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
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Any prior pelvic radiation therapy used to treat prostate cancer
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
2 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
3 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Andrew Vickers, PhD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 11-096