Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy

• Status: Terminated
• Trial end date: 2020-01-15
• Target enrollment: 0
• Participant gender: Male

Summary

This was an open-label, multicenter, prospective trial to assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endocyte; Excel Diagnostics and Nuclear Oncology Center
• Collaborator: University of California, Los Angeles
• Treatments: 177Lu-PSMA-617

Criteria

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 (positron emission computed tomography ) or diagnostic 177Lu-PSMA-617 scintigraphy

6. ECOG 0-2

7. Sufficient bone marrow capacity as defined by WBC (white blood cell ) ≥2.500/μl, PLT (platelet) 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 trail 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 > 1.5 ULN

4. AST and ALT>5xULN

5. Urinary tract obstruction or marked hydronephrosis

6. Diffuse bone marrow involvement confirmed by super-scans