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Active Not Recruiting
NCT01407263
Trial of Modifications to Radical Prostatectomy
Conditions: Prostate Cancer
Sex: Male
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 3204
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering Cancer Center at Basking Ridge Basking Ridge New Jersey
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."
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
Source: ClinicalTrials.gov (NCT01407263). StuddyBuddy aggregates publicly available trial information.