177Lu-PSMA As a Systemic Adjuvant Treatment in Patients with High and Very High Risk Prostate Cancer

Inclusion Criteria:

• Giving a written informed consent

• Histopathologically confirmed high or very high risk prostate cancer

• Completion of radical locoregional treatment

• Completion of locoregional treatment within 3 months before inclusion to the study

• ECOG performance status 0 to 2

• Age over 18 years

• Within 28 days before entering the study, there were no signs of cancerdissemination documented in radiological tests

• Castrate testosterone level (testosteron < 50 ng/dL lub 1,7 nmol/L)

• Patients with adequate function of main organs:

• bone marrow:

• neutrophils > 1500x10^9/L;

• thrombocytes > 100,000x10^9/L;

• hemoglobin > 9 g/dL

• liver:

• bilirubin < 2xULN (upper limit of normal) in patients with Gilbert'ssyndrome < 5xULN;

• aminotransferase < 3xULN

• kidneys:

• eGFR > 50 ml/min

• albumin >2.5 mg/ml

• For men of reproductive age: the need to use double barrier contraception

Exclusion Criteria:

• The presence of distant metastases confirmed by radiological examination

• Absence of approval to use effective contraception method

• Absence of Patient's consent to participate in the Study

• Urinary tract obstruction or/and hydronephrosis.

• Concurrent anticancer treatment.