Overview
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
Description
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
Eligibility
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
- bone marrow:
- 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.