Prostate cancer. Malignant neoplasm of prostate
Conditions
Interventions
Intervention 1: Intervention group: Patient receive ten courses of dostoxel (75 mg / m2) in three weeks with two injections of 177Lu-EDTMP radiopharmaceutical (40 mg / kg in the first injection and 2
Sponsors
Guilan University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with prostate cancer with confirmed histological evidence Bone scan results confirmed metastatic bone prevelance Patients enter the study in the metastatic stage The absolute number of neutrophils is greater than or equal to 10^9 × 1.5 per liter Platelet value greater than or equal to 10^9 × 100 per liter Patients with good renal function (serum creatinine less than 150 µM / L) Good liver function (total bilirubin less than or equal to 1.5 times normal ALT and AST less than or equal to 2.5 times normal
Exclusion criteria
Exclusion criteria: Patients who have already been treated with docetaxel Patients who have already received 177Lu-EDTMP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient pain relief. Timepoint: Assessment periods from the day of injection and 4, 8, 12, 16, 20 and 24 weeks after injection. Method of measurement: Patients complete a visual assessment of pain (VAS) and a questionnaire of quality of life before each course of treatment until the disease progresses. The amount of pain is determined using standard scoring criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects such as bone marrow suppression or a decrease in the number of lymphocytes and platelets. Timepoint: During the study. Method of measurement: Blood Test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Cyrus Amir alavi
Guilan University of Medical Sciences
Outcome results
None listed