NCT07208240

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.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Risk Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-12
• Primary completion: 2028-08-12
• Completion: 2028-08-12
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

1 site across 1 country: Israel