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

The intervention will consist of a single administration of 177Lu-PSMA in the research arm. Both the study and control groups will receive standard hormone therapy.

The study population includes 200 adult men with high-risk or very high-risk prostate cancer, with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy

Participation time in the Study:

intervention phase - 1 day; observation phase - 5 years

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 cancer dissemination 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's syndrome < 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.