Clinical Trial · NCT06449781

177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer

Overview

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

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Phase

Phase 2

Contacts

Agnieszka Ciomber (CONTACT)

agnieszka.ciomber@gliwice.nio.gov.pl

48322789797

Daria Handkiewicz-Junak (CONTACT)

daria.handkiewicz-junak@gliwice.nio.gov.pl

48322789339

ClinicalTrials.gov

NCT06449781

Drug / Compound

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

liver:
albumin \>2.5 mg/ml
Within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests
ECOG performance status 0 to 2
thrombocytes \> 100,000x10\^9/L;
bilirubin \< 2xULN (upper limit of normal) in patients with Gilbert's syndrome \< 5xULN;
Completion of radical locoregional treatment
Completion of locoregional treatment within 3 months before inclusion to the study
kidneys:
Castrate testosterone level (testosteron \< 50 ng/dL lub 1,7 nmol/L)
Histopathologically confirmed high or very high risk prostate cancer
neutrophils \> 1500x10\^9/L;
hemoglobin \> 9 g/dL
aminotransferase \< 3xULN
bone marrow:
Patients with adequate function of main organs:
eGFR \> 50 ml/min

Exclusion

The presence of distant metastases confirmed by radiological examination
Urinary tract obstruction or/and hydronephrosis.
Absence of Patient's consent to participate in the Study
Absence of approval to use effective contraception method
Concurrent anticancer treatment.