The effect of antibiotic therapy on the results of biopsy in asymptomatic men older than 40 years old with PSA above 4 ng/ml
Design
This study is a randomized clinical trial with control group and parallel group design
Settings and conduct
This study is being conducted at Shahid Doctor Rahnamoon Hospital in Yazd City. Eighty Patients older than 40 years of age with prostate-specific antigen (PSA) in the range of 4-15 ng/ml are enrolled based on the criteria for entering the study and are randomly assigned to intervention(Antibiotic therapy) and control (No drug treatment) groups using sealed envelopes. Blinding is not done. In all patients, after 1 month, the PSA level is measured, and patients with PSA level above 4 ng/ml will undergo a standard biopsy(12-core) according to patient's age and PSA density. The biopsy samples will be read and recorded by a pathologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients older than 40 years of age Referring to the Urology Clinic of Shahid Doctor Rahnemoon Hospital in Yazd, Iran with prostate-specific antigen (PSA) in the range of 4-15 ng/ml with normal digital rectal examination (DRE)
and without Irritative and obstructive urinary symptoms. Non-inclusion criteria: Patients undergoing rectal biopsy (TRUS) during the past month, who have ejaculation in the past 28 hours, Patients who have undergone urological surgeries during the past six months, with a history of prostate cancer or clinical and laboratory evidence and with a history of taking 5-alpha-blockers such as Finasteride in the past six weeks do not enter the study.
Intervention groups
Intervention group: Patients will undergo antibiotic therapy (Ciprofloxacin tablets 500 mg every 12 hours for 4 weeks). Control group: Patients won't receive any medication.
Main outcome variables
PSA level ;Prostate biopsy results
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180915041037N1
Registration date:2018-11-11, 1397/08/20
Registration timing:registered_while_recruiting
Last update:2018-11-11, 1397/08/20
Update count:0
Registration date
2018-11-11, 1397/08/20
Registrant information
Name
Samad Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3312 2540
Email address
s.zare@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of antibiotic therapy on the results of biopsy in asymptomatic men older than 40 years of age with PSA above 4 ng/ml
Public title
The effect of antibiotic therapy on the results of biopsy in men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 40 years of age with prostate-specific antigen (PSA) in the range of 4-15 ng/ml
Patients with normal digital rectal examination (DRE)
Patients without Irritative and obstructive urinary symptoms
Patients with informed consent
Exclusion criteria:
Patients undergoing rectal biopsy (TRUS) during the past month.
Patients who have ejaculation in the past 28 hours.
Patients who have undergone urological surgeries during the past six months.
Patients with a history of prostate cancer or clinical and laboratory evidence
Patients with a history of taking 5-alpha-blockers such as Finasteride in the past six weeks
Age
From 40 years old to 70 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly assigned to intervention and control groups using sealed envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2018-10-27, 1397/08/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1397.096
Health conditions studied
1
Description of health condition studied
Prostate Cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
PSA levels above 4 ng / ml
Timepoint
One month after referring to the specialist
Method of measurement
Blood test
Secondary outcomes
1
Description
Biopsy results
Timepoint
One month after referring to the specialist
Method of measurement
Standard biopsy (12-core)
Intervention groups
1
Description
Intervention group: Patients will undergo antibiotic therapy (Ciprofloxacin tablets 500 mg every 12 hours for 4 weeks)
Category
Treatment - Drugs
2
Description
Control group: Patients won't undergo any medication.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Doctor Rahnemoon Hospital
Full name of responsible person
Hadi Maleki
Street address
Farrokhi Street
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0000
Email
hadi.maleki88@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Hadi Maleki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Farrokhi Street
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0000
Email
hadi.maleki88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Samd Zare
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Farrokhi Street
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0000
Email
drzaree@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hadi Maleki
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shahid Doctor Rahnemoon Hospital, Farrokhi Street, Yazd.
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0000
Email
hadi.maleki88@gmail.com
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
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