Excel Diagnostics

PSMA-directed EndoRadiotherapy of Castration-Resistant Prostate Cancer (RESIST-PC). IND # 133661

Excel Diagnostics and Nuclear Oncology Center has received permission from U.S. Food and Drug Administration (FDA) to conduct a clinical trial using Lu-177 PSMA-617 for prostate cancer. This is a targeted radionuclide therapy for metastatic Castration resistant (Hormone refractory) prostate cancer. This is the first phase II of this agent trial offered in U.S.  

Inclusion Criteria: 

  1. Prostate cancer proven by histopathology
  2. Unresectable metastases
  3. Progressive disease, both docetaxel naive and docetaxel treated.
  4. Castration resistant disease with confirmed testosterone level ≤50 ng/ml under prior androgen deprivation therapy (ADT)
  5. Positive 68Ga-PSMA-11 PET/CT or diagnostic 177Lu-PSMA-617 scintigraphy
  6. ECOG 0-2
  7. Sufficient bone marrow capacity as defined by WBC ≥2500/μl, PLT count ≥100.000/μl, Hb≥9.9 g/dl and ANC≥1500 mm3 for the first cycle and  WBC ≥2.000/μl, PLT count ≥75.000/μl, Hb≥8.9 g/dl and ANC≥1000 mm3 for the subsequent cycles 
  8. Patients enrolling in this trial should have received either enzalutamide or abiraterone 

Exclusion Criteria:

  1. Less than 6 weeks since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm) or other radionuclide therapy.
  2. Glomerular Filtration Rate (GFR) <40 ml/min
  3. serum creatinine>1.5xULN
  4. AST and ALT >5xULN
  5. Urinary tract obstruction or marked hydronephrosis 
  6. Diffuse bone marrow involvement confirmed by super-scans  

 Following is the eligibility criteria for participation in this clinical trial:

 

Following is one example of patients benefited from this therapy:

For further information regarding this treatment please contact Ms. Susan Cork at scork@exceldiagnostics.com (phone: 713-341- 3203)or Ms. Amber Gonzales at agonzales@exceldiagnostics.com (Phone: 713-341-3246).

For more information on Lu177-PSMA previous studies please clink HERE.