177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
Recruiting · NCT06449781 · Interventional (participants receive a specific treatment) · Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
View the official record on ClinicalTrials.gov →Interventions studied
Lutetium (177Lu) vipivotide tetraxetan
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch - Gliwice, Poland