Tests lutetium PSMA treatment after surgery or radiation for prostate cancer
Tests lutetium PSMA drug in men with high-risk prostate cancer after main treatment.
Plain-language title generated from the registry record
Registry title: 177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
Key facts
- Where
- Gliwice, PolandSee the site
- Phase
- Phase 2
Where in Poland
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyGliwice, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maria Sklodowska-Curie National Research Institute of Oncology
- Trial code
- NCT06449781EU 2023-504912-13-00
- Record updated
- 16 October 2026
- Original description
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 therapyRead full original descriptionShow less
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
Inclusion: 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: Concurrent anticancer treatment; 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.