This phase III trial compares how different ways of performing prostate cancer surgery, such as lymph node template and closure of port site incision, can affect outcomes in patients with prostate cancer undergoing surgery to remove the entire prostate and some of the tissue around it. Modifications to radical prostatectomy, such as template for lymph node dissection and closure of port site incision, may improve patient outcomes.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01407263.
PRIMARY OBJECTIVES:
I. To evaluate whether lymph node dissection reduces biochemical recurrence rates in patients with negative imaging for lymph node involvement.
II. To determine whether the use of transverse closure of port site incision reduces the risk of hernia compared to vertical incision after minimally invasive radical prostatectomy.
OUTLINE:
Patients undergo radical prostatectomy.
LYMPH NODE TEMPLATE: Patients are randomized to 1 of 2 treatment arms.
LYMPHADENECTOMY: Patients undergo lymph node dissection of the external iliac, hypogastric, and obturator fossa nodal groups.
NO LYMPHADENECTOMY: Patients do not undergo lymph node dissection.
CLOSURE OF PORT SITE INCISION: Patients are randomized to 1 of 2 treatment arms.
TRANSVERSE CLOSURE: Patients undergo transverse closure of port site incision.
VERTICAL CLOSURE: Patients undergo vertical closure of port site incision.
HEMOSTATIC AGENT (HA) USE: Patients are randomized to 1 of 2 treatment arms.
HEMOSTATIC AGENT: Patients receive routine indwelling HA agent according to the surgeons discretion.
NO HEMOSTATIC AGENT: Patients may receive routine indwelling HA agent according to the surgeons discretion.
All patients undergo blood sample collection throughout study.
After completion of study treatment, patients are followed up every 3 months for 1 year and then annually thereafter.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAndrew Vickers
