Evaluation of repeated Prescription of 177Lu-EDTMP combined with docetaxel and prednisone versus docetaxel and prednisone alone in relieving pain in patients with prostate cancer metastatic to bone. A Randomized Clinical Trial

Phase 3

Recruiting

Conditions: C-61
Prostate cancer.
Malignant neoplasm of prostate

Registration Number: IRCT20190303042892N2

Lead Sponsor: Guilan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 30

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

Patients who have already been treated with docetaxel
Patients who have already received 177Lu-EDTMP

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.