177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease
177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease
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 by lowering tumor volume in the prostate and treating small metastases. PET
 PSMA is an advanced imaging technique that allows the identification of areas involved by the
 tumor in the prostate or in the pelvis. This technique is based on the protein PSMA
 (prostate-specific membrane antigen) which is located on the tumor cells. The presence of
 PSMA on tumor cells has been recently used for treatment purposes. A chemical element
 (Lutetium) that binds to PSMA and emits local radiation can destroy tumors cells. This
 treatment has been used in patients with advanced metastatic disease and showed promising
 results. The investigators hypothesized that using these particles can improve long term
 results in patients who undergo surgery for prostate cancer which has not extensively spread.
 The investigators will assess both the immediate and long-term impact of this novel
 treatment.
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).