Status:
RECRUITING
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 loco...
Detailed 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 ...
Eligibility Criteria
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.
Key Trial Info
Start Date :
January 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06449781
Start Date
January 9 2025
End Date
November 1 2030
Last Update
February 10 2025
Active Locations (1)
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1
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland, 44-101