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

Primary goal of this study is evaluation of safety and efficacy of 177Lu-PSMA-617.

Safety of 177Lu-PSMA-617 (Radioligand Therapy) RLT will be assessed by analysis of toxicity.
Descriptive statistics (number and percentage) will be reported separately for Adverse Events
(AE) in total and Serious Adverse Events (SAE). These descriptive statistics will be
presented for the whole treatment as well as separate for each cycle. In addition, the
relationship of AE to the study drug (related, not related) will be reported. Both results
from laboratory test, physical examinations and patients surveys will be included.

Efficacy of 177Lu-PSMA-617 will be reported using descriptive statistics by means of number
and percentage of patients with ≥50% decline at 12-weeks from baseline.

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