Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer

Inclusion Criteria:

• Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures.

• Histologically proven localized adenocarcinoma of the prostate.

• High-risk prostate cancer or intermediate-risk prostate cancer defined by D'Amico classification system, with an estimated risk of >5% of lymph node metastasis.

• Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence.

• Age ≥ 18 years and ≤ 80 years.

• WHO performance status 0-1.

• Adequate condition (ASA ≤ III) for general anesthesia and radical prostatectomy surgery.

• Baseline Quality of Life (QoL) questionnaires have been completed.

Exclusion criteria

• Any pre-operative evidence for T4 disease.

• Metastatic prostate cancer according to staging or evidence of lymph node metastasis by imaging, defined as any pelvic lymph node >9 mm in the short axis or positive lymph nodes detected by imaging techniques with sensitivities similar or better than PSMA-PET or Choline-PET prior to surgery.

• PSA ≥ 50 ng/ml.

• Any prior neo-adjuvant, local or systemic treatment for prostate cancer (alpha reductase inhibitors for treatment of benign hyperplasia are allowed)

• Previous pelvic lymph node dissection.

• Any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.

• Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.