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Taking people in IsraelPhase 1/2

Tests Tb-PSMA radionuclide before surgery for locally advanced prostate cancer

Tests Tb-PSMA radionuclide treatment before prostate removal in men with prostate cancer.

Plain-language title generated from the registry record
Registry title: Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.

Key facts

Where
Petah Tikva, IsraelSee the site
Phase
Phase 1/2

Where in Israel

  • Beilinson HospitalPetah Tikva, IsraelTaking people

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Trial details

Who runs it
Rabin Medical Center
Trial code
NCT07208240
Record updated
6 October 2025
Original description
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.Read full original descriptionShow less

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

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.

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

Exclusion: usage of nephrotoxic drugs; distant metastatic disease; Platelet count lower than 150×103/µl; white blood cell count lower than 4×103/µl,; haemoglobin concentration lower than 12mg/dl; albumin concentration lower than 3.5 g/dl; glomerular filtration rate (GFR) lower than 40 mL/min.

ClinicalTrials.gov NCT07208240