Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment

The PLATIN trial is designed as a prospective, non-randomized, five-arm trial. Arm 1: Definitive radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate.

Arm 2: As arm 1, with additional boost to macroscopic lymph node metastases. Arm 3: Postoperative radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate bed.

Arm 4: As arm 3, additional boost to macroscopic lymph node metastases. Arm 5: Patients with previous radiotherapy to the prostate bed. Radiotherapy of the pelvic lymphatic drainage above the previous treatment fields with integrated boost to macroscopic lymph node metastases.

Inclusion criteria

• histologically confirmed prostate cancer with Gleason Score
• risk of lymph node involvement >20% (according to Roach Formula), pelvic lymph node metastases in CT/MRI or histologically confirmed lymph node involvement
• Karnofsky Index >/= 70%
• age 18-75 years
• neoadjuvant antihormonal treatment for 2 months, continuation until the end of radiotherapy
• written informed consent

Exclusion criteria

• stage IV (distant metastases)
• lymph node metastases outside the pelvis
• rising prostate-specific antigen (PSA) under antihormonal treatment
• severe wound complications after laparatomy
• severe lymph edema of the legs, elephantiasis, postthrombotic syndrome
• decompensated comorbidity of the lungs, heart, metabolic system, hematopoetic system or kidneys, coagulopathy
• history of other malignancy within the last 5 years (except for basal cell carcinoma or squamous carcinoma of the skin)
• previous irradiation of the pelvic lymph nodes
• concurrent participation in a clinical trial that might influence the results of either trial