Status:
UNKNOWN
177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease
Lead Sponsor:
Rabin Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Despite surgical advances, up to 50% of patients with high-risk locally advanced prostate cancer will die from their disease. Drug therapy before surgery has the potential to improve treatment success...
Eligibility Criteria
Inclusion
- 1\. Male aged 18 years and older. 2. Patients were diagnosed with high risk localized prostate cancer (cT3/4 and/or Gleason score ≥8 and/or prostate biopsy or PSA ≥ 20 ng/dl) or loco-regional prostate cancer (pelvic lymphadenopathy of ≥2 cm on axial imaging).
- 3\. High PSMA expression was confirmed. PET PSMA with tracer uptake greater than normal liver (maximal standardized uptake value ≥1.5 of liver). In addition, no PET FDG positive sites without high PSMA expression.
- 4\. Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score5 of 1 or lower and life expectancy of \> 10 years.
Exclusion
- 1\. Clinically significant impaired bone marrow defined by platelet count lower than 150×103/µl, white blood cells count lower than 4×103/µl, hemoglobin concentration lower than 12mg/dl.
- 2\. Impaired liver function defined by albumin concentration lower than 3.5 gr/dl.
- 3\. Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40 mL/min.
- 4\. Recent radiotherapy (within two months) 5. Concomitant usage of nephrotoxic drugs 6. Evidence of distant metastatic disease (distal lymphadenopathy, visceral or bone metastases).
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 20 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04297410
Start Date
November 20 2019
End Date
April 20 2022
Last Update
March 5 2020
Active Locations (1)
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1
Rabin Medical Center, Beilinson hospital
Petah Tikva, Israel, 4941494