This phase II clinical trial will be carried out on patients with metastatic prostate cancer who refer to Shohadaaye-Tajrish Urology clinic. Metastatic prostate cancer patients without previous treatment will be allocated to two groups and receive one of treatments (Leupromer or Eligard) as study protocol. Sample size in study and control arm is 33 and 65 retrospectively. The outcome will be assessed using serum testosterone level and PSA and LH test after 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206131030N10
Registration date:2012-12-27, 1391/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-27, 1391/10/07
Registrant information
Name
Mahdi Jalili
Name of organization / entity
Hematology-Oncology & SCT Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2662
Email address
m_jalili@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran Polymer and petrochemical institute
Expected recruitment start date
2012-11-05, 1391/08/15
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Therapeutic and Adverse Effects of
Leupromer (Iranian Formulated LHRH agonist) and Eligard
in patients with Metastatic Prostate Cancer
Public title
Comparison of Therapeutic and Adverse Effects of
Leupromer (Iranian Formulated LHRH agonist) and Eligard
in patients with Metastatic Prostate Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Paetient with metastatic prostate cancer who examined by paraclinical diagnostics. (i.e.: needle biopsy of prostate, pathologic trans rectal sonography bone scan, CT-scan and MRI) and assessd their bone and viscera; 2- Must be Iranian; 3-Signed the testimonial form by own awareness. 4-Confidency of patient cooperation with administering drug; 5-Assitance of patient to come with scheduled program. Exclusion criteria: 1-Disorder in hypothalamus-hypophysis-gonadal axis; 2-Previous treatment with GnRH analog or other hormonal treatment or chemotherapy in last three month; 3-Radioteraohy in last two month; 4-Malignant with active origin; 5-Need to adjuvant treatment; 6-Urinary obstruction or spinal cord compression; 7- Administering with other drug (cooperating with another study); 8- Dissatisfaction of patient; 9-Probability of impossibility of following by patient; 10-drug addiction; 11- allergy to GnRH analogs or any kind of GnRH.
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences,6 th floor of Tehran University of Medical Sciences,ghods St., Keshavarz blv,Tehran, Iran
City
Tehran
Postal code
Approval date
2012-10-28, 1391/08/07
Ethics committee reference number
124-91/8/7
Health conditions studied
1
Description of health condition studied
Metastatic prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Ratio of serum PSA level regarding to baseline
Timepoint
28, 56 and 84 day after beginning of treatment
Method of measurement
PSA tumor marker (ng/ml)
Secondary outcomes
1
Description
Testosterone serum level
Timepoint
28, 56 and 84 day after beginning of treatment
Method of measurement
Testosterone blood level (ng/dl)
2
Description
LH serum level
Timepoint
28, 56 and 84 day after beginning of treatment
Method of measurement
LH blood level (IU/L)
3
Description
Side effect frequency
Timepoint
Three month after beginning day of treatment
Method of measurement
Examination and following treatment
4
Description
Bone pain decreasing frequency
Timepoint
Three month after beginning day of treatment
Method of measurement
Examination and following treatment based on 1-10 score
5
Description
Frequency of reduction in urinary pain
Timepoint
Three month after beginning day of treatment
Method of measurement
Examination and following treatment based on 1-10 score
6
Description
Frequency of reduction in urinary symptom
Timepoint
Three month after beginning day of treatment
Method of measurement
Examination and following treatment based on 1-10 score
Intervention groups
1
Description
Leupromer 7.5mg every 28 day for 3 times
Category
Treatment - Drugs
2
Description
Eligard 7.5mg every 28 day for 3 times
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Urology Clinic
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran Polymer and petrochemical institute
Full name of responsible person
Dr. Alireza Nateghi
Street address
Iran Polymer and Petrochemical Institute (IPPI) P.O. Box 14965/115
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Polymer and petrochemical institute
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hasanzade
Position
Urology assistance
Other areas of specialty/work
Street address
Shohadaye Tajrish Urology Clinic, Shahdari Ave, Tajrish circle
City
Tehran
Postal code
Phone
+98 21 2271 8014
Fax
Email
soheilahasoory@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Jalili Hossieni
Position
Associate Professor/Urologist
Other areas of specialty/work
Street address
Shohadaye Tajrish Urology Clinic, Shahdari Ave, Tajrish circle
City
Tehran
Postal code
Phone
+98 21 2271 8014
Fax
Email
soheilahasoory@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Varian Daroo Pazhoh
Full name of responsible person
Dr Hamid Mobedi
Position
PhD
Other areas of specialty/work
Street address
Iran Polymer and petrochemical institute, Pazhoh Blvd, Hemat Blvd
City
Tehran
Postal code
1497713115
Phone
+98 21 4458 0063
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)