Many patients with early-stage prostate cancer undergo prostatectomy with simultaneous removal of the pelvic lymph nodes and of fatty and connective tissue in the pelvic region. However, controversy surrounds the benefit that additional removal of the pelvic lymph nodes may have for the subsequent course of the disease. Moreover, this procedure extends the duration of surgery by about 40-60 minutes.
Trial SAKK 09/18 investigates the effect that removal of the pelvic lymph nodes has on the course of the disease and patient's prognosis. Men aged between 18 and 80 with localized prostate cancer are admitted to the trial if they exhibit a medium to high risk of lymph node metastasis and if surgical removal of the patient's prostate gland is planned. Patients in whom lymph node metastasis has been detected through diagnostic imaging prior to the operation are not admitted.
The trial subjects are randomly assigned to two groups: In one group the patients undergo prostatectomy with simultaneous removal of the pelvic lymph nodes, while in the other group prostatectomy is performed without removal of the pelvic lymph nodes. Thereafter, the patients will undergo regular follow-up examinations for up to 15 years after the operation.