177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease (NALuPROST)
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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).
Sites / Locations
- Rabin Medical Center, Beilinson hospitalRecruiting
Arms of the Study
Arm 1
Experimental
Neoadjuvant LuPSMA