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

177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy

Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy

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.