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.
- Prostate cancer proven by histopathology
- Unresectable metastases
- Progressive disease, both docetaxel naive and docetaxel treated.
- Castration resistant disease with confirmed testosterone level ≤50 ng/ml under prior androgen deprivation therapy (ADT)
- Positive 68Ga-PSMA-11 PET/CT or diagnostic 177Lu-PSMA-617 scintigraphy
- ECOG 0-2
- 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
- Patients enrolling in this trial should have received either enzalutamide or abiraterone
- Less than 6 weeks since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm) or other radionuclide therapy.
- Glomerular Filtration Rate (GFR) <40 ml/min
- serum creatinine>1.5xULN
- AST and ALT >5xULN
- Urinary tract obstruction or marked hydronephrosis
- 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 firstname.lastname@example.org (phone: 713-341- 3203)or Ms. Amber Gonzales at email@example.com (Phone: 713-341-3246).
For more information on Lu177-PSMA previous studies please clink HERE.