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

Not Applicable

Recruiting

• Conditions: High Risk Prostate Cancer
• Interventions: Drug: Tb-PSMA-I&T (Tb-PSMA)

• Registration Number: NCT07208240
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-12
• Study First Submitted: 2025-08-12
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06
• Primary Completion: 2028-08-12
• Study Completion: 2028-08-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients receiving Tb-PSMA before RAdical prostatectomy	Tb-PSMA-I&T (Tb-PSMA)	Patients with high-risk locally advanced prostate cancer will receive 3 Tb-161-PSMA treatments followed by radical prostatectomy.

Primary Outcome Measures

Name	Time	Method
Surgical and clinical safety	1 year	The primary outcome is the safety of administering Tb-PSMA before radical prostatectomy, its impact on intra- and post-operative clinical course according to the Clavien-Dindo Classification.
Number of Tb-PSMA adverse effects measured by CTCAE v4.0 and number of surgical complications - measured by the Clavien-Dindo Classification (2009)	1 year

Secondary Outcome Measures

Name	Time	Method
Immediate oncological outcomes as measured by number of patients with positive surgical margins and number of patients who achieved biochemical complete response	3 months	Secondary outcomes include the immediate response to treatment in terms of biochemical response. A post-surgical prostate specific antigen above 0.1 ng/ml is considered biochemical failure.

Trial Locations

Locations (1)

Beilinson Hospital; 🇮🇱 Petah Tikva, Israel