RecruitingPhase 1Phase 2NCT07208240

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.

Sponsor

Rabin Medical Center

Enrollment

20 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

High-risk Prostate Cancer

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study gives men with high-risk prostate cancer a targeted radioactive treatment (Tb-PSMA-I&T) before surgical removal of the prostate. The goal is to see whether this pre-surgery treatment can shrink the tumor and improve outcomes. **You may be eligible if...** - You are a male aged 18 or older - You have been diagnosed with high-risk localized prostate cancer (specific tumor stage, Gleason score ≥8, or PSA ≥20 ng/dL) - Your prostate cancer cells express high levels of a protein called PSMA (confirmed by scan) - You are in good overall health and have a life expectancy of more than 10 years **You may NOT be eligible if...** - Your blood counts (platelets, white cells, hemoglobin) or protein (albumin) levels are too low - Your kidney function is reduced (GFR below 40 mL/min) - You are taking medications that are toxic to the kidneys - Your cancer has already spread to distant parts of the body Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTb-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