Status:
RECRUITING
Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.
Lead Sponsor:
Rabin Medical Center
Conditions:
High Risk Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
August 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 12 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07208240
Start Date
August 12 2025
End Date
August 12 2028
Last Update
October 6 2025
Active Locations (1)
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1
Beilinson Hospital
Petah Tikva, Israel