Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Endocyte
Upon inclusion patients were randomized in a 1:1 ratio into two treatment doses. Radioligand therapy (RLT) were performed by repeated intravenous (i.v.) injection of 6.0 gigabecquerel (GBq) (+/- 10%) or 7.4 GBq (+/- 10%) 177Lu-PSMA-617 every 8+/- 1 weeks until reaching four cycles or threshold maximum dose to the kidneys of 23 Gray (Gy). All doses after labeling were presented in buffered solution for i.v. injection.
In the initial plan for the study design a total of 200 patients with histologically proven prostate cancer and metastatic castration-resistant prostate cancer (mCRPC) were to be enrolled, however due to early stopping of enrollment only 71 patients were enrolled at time of data base lock. Each patient underwent a screening visit within 14 days prior to receiving study drug. Treatment was continued until either of the following conditions applied:
* Prostate-specific antigen (PSA)/radiographic progression at \>= 12 weeks
* Completion of four RLT cycles
* 23 Gy kidney dose would be exceeded by the next cycle as estimated by dosimetry
* Patient withdrawal (e.g. appearance of intolerable adverse events).
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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)
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
You may not be if
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
