TheranosticTrials.org

Clinical Trial · NCT07208240

Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.

Overview

This is a multi-disciplinary collaboration between urologists, oncologists and nuclear medicine physicians from Beilinson hospital at Rabin Medical Center to address the major therapeutic challenge of locally advanced prostate cancer. Our aim is to evaluate the use of a novel treatment (Tb-PSMA) prior to the surgical removal of the prostate. This treatment has already shown initial promising results in patients with metastatic prostate cancer but has never been tested for locally advanced disease before surgery.

Sponsor

Asan Medical Center

Phase

Phase 1/2

Contacts

Shay Golan, MD (PRINCIPAL_INVESTIGATOR)

Hana Burnstein, MD (CONTACT)

hanna@erezcom.net

+972544400822

Shay Golan, MD (CONTACT)

shaygo1@gmail.com

+972507447573

ClinicalTrials.gov

NCT07208240

Drug / Compound

PSMA-I&T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Patients with high-risk localized prostate cancer (cT3/4 and/or Gleason score ≥ eight and/or prostate biopsy or PSA ≥ 20 ng/dl)
  • Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or lower and a life expectancy of \> 10 years.
  • * Male aged 18 years and older.
  • High PSMA expression was confirmed according to PROMISE V2 8

Exclusion

  • haemoglobin concentration lower than 12mg/dl.
  • albumin concentration lower than 3.5 g/dl.
  • glomerular filtration rate (GFR) lower than 40 mL/min.
  • white blood cell count lower than 4×103/µl,
  • * Platelet count lower than 150×103/µl