Excel Diagnostics

PSMA-directed EndoRadiotherapy of Castration-resISTant prostate cancer (PERCIST). IND # 133661

 

This is a targeted radionuclide therapy for metastatic Castration resistant (Hormone refractory) prostate cancer.  This treatment is offered for the first time in U.S.

I would highly appreciate if you can inform the patients regarding the availability of this treatment at our center. The treatment appears to be very promising. Attached, please find a recently published peer reviewed manuscript regarding this treatment. Following is one example of patients benefited from this therapy:

Please contact Ms. Susan Cork , Senior Therapy Coordinator, Excel Diagnostics and Nuclear Oncology Center at 713-341-3203 or scork@exceldiagnostics.com  for referral or further information.

 

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. Signing of the Informed Consent Form  
  9. 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. Patients who had received both docetaxel and cabazitaxel will be excluded from this study. Enrolment will be limited to patients who had received prior docetaxel only.  
  7. Diffuse bone marrow involvement confirmed by super-scans  

 
Test Product; Dose; and Mode of Administration: Randomization into two treatment doses; radioligand therapy (RLT) by repeated i.v. application of 6.0 GBq (±10%, arm 1) or 7.4 GBq (±10%, arm 2) 177Lu-PSMA-617 every 8±1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry after the first treatment. 
 
Study Duration: Patients will be followed until either of the following conditions occur: 1. 24 month after the first treatment. 2. Progression by RECIST 1.1/PCWG3  criteria. 3. Death.

 

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