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IRCT20190303042892N2 IRCT 2021-04-22 Guilan University of Medical Sciences 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 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 2021-04-21 anticipated 30 Complete https://irct.ir/trial/54021 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is of the limited randomization type until all groups (in our study both groups) have an equal sample size and the random allocation law will be used to balance the number of people assigned to each group in End the study (random block method). For this purpose, Random allocation software and SAS software can be used, which SAS software will be more appropriate. In addition, the websites www.randomization and www.graghpad.com/quickcalcs/index.cf are available and the second website will be used for this purpose, Blinding description: Since one group of patients (intervention group) receives one drug more than the control group, which is actually the same as the radiopharmaceutical 177Lu-EDTMP, and because of the use of radiopharmaceuticals, it is not possible to use placebo, so patients in this study can not be blinded. But the doctor and the main researcher and the evaluator and data collector are blind. 3 Prostate cancer. 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 20 mg / kg / kg in the second injection). In the first injection, they receive 2590 megabecrels and in the second injection, 1295 megabecrels of radiopharmaceuticals. The radiopharmaceutical injection will be done after the third and sixth period of docetaxel administration. All patients will take prednisolone orally at a dose of 5 mg daily. Intervention 2: Control group: Patient receive ten courses of dostoxel (75 mg / m2) in three weeks.All patients will take prednisolone orally at a dose of 5 mg daily. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr. Cyrus Amir alavi
Parastar Ave
Rasht Iran (Islamic Republic of) 41937-13111 +98 13 3332 5783 Cyrusemiralavi@yahoo.com Guilan University of Medical Sciences scientific Dr.Mona Haddad
Parastar Ave
Rasht Iran (Islamic Republic of) 41937-13111 +98 13 3348 6470 haddad@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Male Patients who have already been treated with docetaxel Patients who have already received 177Lu-EDTMP C-61 Malignant neoplasm of prostate Rehabilitation Rehabilitation 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 20 mg / kg / kg in the second injection). In the first injection, they receive 2590 megabecrels and in the second injection, 1295 megabecrels of radiopharmaceuticals. The radiopharmaceutical injection will be done after the third and sixth period of docetaxel administration. All patients will take prednisolone orally at a dose of 5 mg daily. Control group: Patient receive ten courses of dostoxel (75 mg / m2) in three weeks.All patients will take prednisolone orally at a dose of 5 mg daily. 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. 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. Guilan University of Medical Sciences Approved 2021-01-20 Ethics committee of Guilan University of Medical Sciences Parastar Ave Rasht Guilan Iran (Islamic Republic of)