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
Maria Sklodowska-Curie National Research Institute of Oncology
200 participants
Jan 9, 2025
INTERVENTIONAL
Conditions
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 locoregional teleradiotherapy and hormone therapy
Eligibility
Inclusion Criteria20
- 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 Criteria5
- 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.
Interventions
The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06449781