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
Determining the effectiveness of double administration of 177-Lu-EDTMP radiopharmaceutical with prednisolone with prednisolone versus administration of alone docetaxel with prednisolone in relieving the pain of bone metastases in patients with prostate cancer
Design
In this study, a randomized clinical trial (Phase III) was piloted on 30 patients.Randomization is of the limited randomization type
Settings and conduct
The place of work will be Besat Clinic in Rasht.Eligible patients are randomly divided into two groups with equal ratios.The study will be double blinded . The patient receives the drug (intervention or comparison group) in sealed packets that are coded. The coding is done by one of the project partners and the doctor, the evaluator and the data collector are blind.
Participants/Inclusion and exclusion criteria
Patient over 18 years of age, absolute neutrophil count greater than or equal to 10^9 × 1.5 per liter, platelets greater than or equal to 10^9 × 100 per liter,serum creatinine less than 150 μM Liters , total bilirubin less than or equal to 1.5 times normal, ALT and AST less than or equal to 2.5 times normal. Patients who have previously used Dostoxel or have been exposed to 177Lu-EDTMP radiopharmaceuticals will not be eligible for the study. Patients should be in stage 4 disease
Intervention groups
Intervention group:Patients receive ten cycles of docetaxel (75 mg / m2) in three weeks with double radiopharmaceutical injection of 177Lu-EDTMP (40 mg / kg in the first injection and 20 mg / kg / kg in the second injection). patients will take prednisolone orally at a dose of 5 mg per day.
control group: Patients receive ten cycles of docetaxel (75 mg / m2) in three weeks. patients will take prednisolone orally at a dose of 5 mg per day.
Main outcome variables
Patient pain evaluation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190303042892N2
Registration date:2021-04-22, 1400/02/02
Registration timing:registered_while_recruiting
Last update:2021-04-22, 1400/02/02
Update count:0
Registration date
2021-04-22, 1400/02/02
Registrant information
Name
Mona Haddad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
haddad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Supportive
Inclusion/Exclusion 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:
Patients who have already been treated with docetaxel
Patients who have already received 177Lu-EDTMP
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Parastar Ave
City
Rasht
Province
Guilan
Postal code
41937-13111
Approval date
2021-01-20, 1399/11/01
Ethics committee reference number
IR.GUMS.REC.1399.519
Health conditions studied
1
Description of health condition studied
Prostate cancer
ICD-10 code
C-61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
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 outcomes
1
Description
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
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat clinic
Full name of responsible person
Dr. Seyed Hossein Mirpour
Street address
Enghelab Ave
City
Rasht
Province
Guilan
Postal code
11111
Phone
+98 13 3326 1451
Email
haddad@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Naghipour
Street address
Parastar Ave
City
Rasht
Province
Guilan
Postal code
41937-13111
Phone
+98 13 3332 6064
Email
haddad@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Cyrus Amir alavi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Parastar Ave
City
Rasht
Province
Guilan
Postal code
41937-13111
Phone
+98 13 3332 5783
Email
Cyrusemiralavi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr.Mona Haddad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Parastar Ave
City
Rasht
Province
Guilan
Postal code
41937-13111
Phone
+98 13 3348 6470
Email
haddad@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr.Mona Haddad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Parastar Ave
City
Rasht
Province
Guilan
Postal code
41937-13111
Phone
+98 13 3348 6470
Email
haddad@gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available