RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. - usage of nephrotoxic drugs - distant metastatic disease Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: * 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. * usage of nephrotoxic drugs * distant metastatic disease

Treatments Being Tested

DRUG

Tb-PSMA-I&T (Tb-PSMA)

Terbium-161 produce beta emission with the addition of Auger electrons which have higher linear energy transfer and a very short range. By that it has the potential to improve local and distal (micro-metastatic disease) efficacy with a similar safety profile. It will be given to patients with high risk locally advanced prostate cancer prior to Radical prostatectomy

Locations (1)

Beilinson Hospital

Petah Tikva, Israel