The effect of finasteride (compared to placebo) in preventing recurrence in patients with bladder tumor
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, Phase 2 on 124 patients. Excel software function was used to randomize.
Settings and conduct
This study is a randomized clinical trial, double-blind at a time period from 2021 to 2022. The subjects of the study included all patients with bladder tumors referred to Imam Reza Hospital in Tabriz which was treated as primary and non-consecutive. After entering the study and obtaining consent, for all patients (control and intervention group) at the moment of entering the study, according to the bladder tumor, diagnostic and therapeutic measures are performed according to the physician's decision-making.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Patients with bladder tumor
2satisfaction to enter the study
3insensivity to drug
4-patient cooperation during the study
5-age 18 to 70 years
Exclusion criteria:
1-Lack of consent to enter the study
2loss of patient in pursuit
3-Age less than 18 years and more than 70 years
4death of the patient to other causes
5-Lack of proper drug use
6-sensitivity to drug and Azasteroids pharmaceutical group
7-patients with underlying hepatic disease
8-Patients with breast cancer
9-Patients with prostate cancer
Intervention groups
Intervention group: Patients with bladder tumors who receive finasteride 5 mg/day from 2021 to 2022
Control group: Patients with bladder tumors who receive placebo tablets, per day from 2021 to 2022
Main outcome variables
Urine analysis, Biopsy of bladder tumor If tumor found at follow-up cystoscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047702N1
Registration date:2021-12-25, 1400/10/04
Registration timing:registered_while_recruiting
Last update:2021-12-25, 1400/10/04
Update count:0
Registration date
2021-12-25, 1400/10/04
Registrant information
Name
Reza Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 2321 0333
Email address
dr.ramezanireza70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of finasteride (compared to placebo) in preventing recurrence in patients with bladder tumor
Public title
The effect of finasteride in the prevention of bladder tumor recurrence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with bladder tumors, which are candidates of fallow up
Consent to inclusion the study
insensitivity to drug
Patient cooperation during the study
Age 18 to 70 years
Exclusion criteria:
No consent to the inclusion of the study
Loss of patient in f/u
No regular drug use
Patients with underlying disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
124 envelopes are prepared with 62 active and 62 placebo cards and shuffled. Patients are allocated the next study number (1–124) in sequence after opening the sealed envelopes to either drug or placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher does not know whether the patient being evaluated belongs to the placebo group or the finasteride group. The patients also do not know if they have used a placebo or finasteride. Drugs and placebos are similar in appearance, such as color, shape, and so on. The patient (placebo or treatment groups) receives the encoded drug
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of tabriz medical university
Street address
imam reza hospital urology department
City
tabriz
Province
West Azarbaijan
Postal code
1212121212
Approval date
2021-06-04, 1400/03/14
Ethics committee reference number
IR.tbzmed.REC.1400.234
Health conditions studied
1
Description of health condition studied
bladder cancer
ICD-10 code
C67.9
ICD-10 code description
Malignant neoplasm of bladder, unspecified
Primary outcomes
1
Description
prevention of recurrence of bladder cancer
Timepoint
before intervention and every 3 months for a period of one year
Method of measurement
cystoscopy pathology report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Finasteride ( Daru Pakhsh CO. Tehran, Iran) receive 5 mg /day and complications and response to treatment are evaluated every three months
Category
Treatment - Drugs
2
Description
Control group: Receive placebo (in the form of finasteride tablets) (Construction of Faculty of Pharmacy, Tabriz University of Medical Sciences)tablet per day for up to one year
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
imam reza hospital of tabriz
Full name of responsible person
danial farhadi
Street address
golgasht ave,imam reza hospital
City
tabriz
Province
West Azarbaijan
Postal code
1212121212
Phone
+98 41 3526 2250
Email
dr.ramezanireza70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
mohammad samiee
Street address
Golgasht Street. Research and Technology, University of Tabriz
City
tabriz
Province
West Azarbaijan
Postal code
1234567891
Phone
+98 41 3335 7310
Email
dr.ramezanireza70@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
alireza farshi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
golgasht ave,imam reza hospital
City
tabriz
Province
West Azarbaijan
Postal code
1212121212
Phone
+98 41 3337 6923
Email
dr.ramezanireza70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Ramezani
Position
Resident of urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No 1,saadi alley,azari ave,valiasr jonubi blvd,tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
1212121212
Phone
+98 41 2321 0333
Fax
Email
Dr.ramezanireza70@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Ramezani
Position
Resident of urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No 1,saadi alley,azari ave,valiasr jonubi blvd,tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
1212121212
Phone
+98 41 2321 0333
Fax
Email
Dr.ramezanireza70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data on the outcome of bladder tumors is for sharing.
When the data will become available and for how long
Access will be 6 months after the results are printed.
To whom data/document is available
Urologic specialists in coordination with the presenter
Under which criteria data/document could be used
The use of data to improve patients' treatment processes is safe
From where data/document is obtainable
The person responsible for updating study information: dr Reza Ramezani
Email: Dr.ramezanireza70@gmail.com
What processes are involved for a request to access data/document
Requesting data and study documents will be done by correspondence with the person responsible for updating the study information