Maria Sklodowska-Curie National Research Institute of Oncology
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
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | 177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
