Purpose: To assess the efficacy of variopeptyl in decreasing serum testosterone and PSA level in patients with metastatic prostate cancer(It is our objective to evaluate the effect of this drug in reducing the level of Prostate specific antigen and serum Testosterone). Inclusion Criteria: All patients with metastatic prostate cancer without age limitation who are referred to urology clinic of Imam Khomeini Hospital, Filling consent form and Not receiving hormone therapy before
Exclusion Criteria:1. dysfunction in Hypothalamic - pituitary - gonadal axis 2. Simultaneous presence of active malignancy with different origin 3. Require the other treatments (chemotherapy, radiotherapy) 4.Inability to obtain consent due to dissatisfaction or intellectual problems
5. History of hypersensitivity to GnRH, GnRH analogs 6. History of bilateral orchiectomy
Method: 47 consecutive patients with metastatic prostate cancer who are candidates for receiving LHRH agonist are potential eligible participants. Written Informed consent will be obtained from all patients. In this study, 3.75 mg of variopeptyl will be injected subcutaneously every 28 days and PSA and serum Testosterone is measured before intervention and at 1, 3 and 6 month intervals.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410289819N5
Registration date:2015-07-09, 1394/04/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-09, 1394/04/18
Registrant information
Name
Mohammadreza Nowroozi
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2764
Email address
uorc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Tehran University of Medical Sciences
varian daru Pharmaceutical Company
Expected recruitment start date
2014-11-08, 1393/08/17
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Therapeutic Effects of variopeptyl (Iranian Formulated LHRH agonist) in patients with Metastatic Prostate Cancer
Public title
Efficacy of variopeptyle in treating MPCa
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: All patients with metastatic prostate cancer without age limitation who are referred to urology clinic of Imam Khomeyni Hospital, Filling consent form and Not receiving hormone therapy before
Exclusion Criteria:1. dysfunction in Hypothalamic - pituitary - gonadal axis 2. Simultaneous presence of active malignancy with different origin 3. Require the other treatments (chemotherapy, radiotherapy) 4.Inability to obtain consent due to dissatisfaction or intellectual problems
5. History of hypersensitivity to GnRH, GnRH analogs 6. History of bilateral orchiectomy
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
47
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Of Tehran University Of Medical Sciences
Street address
Central Organization Of Tehran University Of Medical Sciences, Qods St, Keshavarz Blvd Tehran
City
Tehran
Postal code
Approval date
2014-07-20, 1393/04/29
Ethics committee reference number
92-03-11-23568-118042
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
Testostrone
Timepoint
Before intervention, one month after intervention, three months after intervention and six months after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
PSA
Timepoint
Before intervention, one month after intervention, three months after intervention and six months after intervention
Method of measurement
ELISA
Intervention groups
1
Description
Variopeptyl 3.75 milligram ( which is LHRH agonist) each 28 days,until 6 months, subcutaneous,Produced by varian daru company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Clinic Of Imam khomeyni Hospital
Full name of responsible person
erfan amini
Street address
Imam Khomeyni Hospital, Keshavarz Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Tehran University of Medical Sciences
Full name of responsible person
Yonesian Masud
Street address
Central Organization of Tehran University of Medical Sciences, Qods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Uro oncology research center, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Amini Erfan
Position
Faculty
Other areas of specialty/work
Street address
Uro oncology Research Center of Imam Khomeyni Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6690 3063
Fax
Email
amini.erfan@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Uro oncology research center, Tehran University of Medical Sciences, Tehran, Iran Imam Khomeyni Hosp
Full name of responsible person
Ayati Mohsen
Position
Faculty
Other areas of specialty/work
Street address
Uro oncology research center, Imam khomeyni Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6690 3063
Fax
Email
DrAYATI_mohsen@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Uro oncology research center, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Amini Erfan
Position
Faculty
Other areas of specialty/work
Street address
Uro oncology Research Center of Imam Khomeyni Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6690 3063
Fax
Email
amini.erfan@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)