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

Stopped early · Phase 2

Conditions studied: Metastatic Castration Resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03042312

Run by

Endocyte

People needed

71

Starts

2017-07-12

Expected to finish

2020-01-15

Last updated by the study team

2021-03-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 (positron emission computed tomography ) or diagnostic 177Lu-PSMA-617 scintigraphy
• ECOG 0-2
• 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
• Signing of the Informed Consent Form
• Patients enrolling in this trail should have received either Enzalutamide or Abiraterone

You may not qualify if…

• 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 > 1.5 ULN
• AST and ALT>5xULN
• Urinary tract obstruction or marked hydronephrosis
• Diffuse bone marrow involvement confirmed by super-scans

Where it is running

• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Excel Diagnostics and Nuclear Oncology Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.