A Randomized Trial of Modifications to Radical Prostatectomy
Overview
- Phase
- Phase 3
- Intervention
- Lymph node template
- Conditions
- Prostate Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 3204
- Locations
- 5
- Primary Endpoint
- Patient-reported hernia
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
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."
Investigators
Eligibility 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
- •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
Exclusion Criteria
- •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 on CT or MRI, a PSMA avid node, 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
Arms & Interventions
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.
Intervention: Lymph node template
Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)
Intervention: Transverse versus vertical closure
One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)
Intervention: antibiotic prophylaxis
Hemostatic agent vs. no hemostatic agent
Intervention: Hemostatic Agent
Outcomes
Primary Outcomes
Patient-reported hernia
Time Frame: 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 Outcomes
- To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates(2 years)
- urinary tract infection (UTI)(within 10 days)