Protocol summary
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Study aim
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Evaluation of pharmacokinetic parameters based on measurement of serum triptorelin concentration, Evaluation of pharmacodynamic parameters based on measurement of decreased sex hormone levels (reduction of serum testosterone level to castration level) of patients with non-metastatic or metastatic prostate cancer.
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Design
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This clinical trial is a bioequivalence study, randomized, double-armed, double-blind, parallel, with a 1: 1 ratio of volunteers.
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Settings and conduct
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This clinical trial at Isfahan Poursina Research center and Tehran Khatam-al Anbiya hospital begins to accept volunteer patients. This study is double-blind and the patient and the principal investigator are unaware of the type of prescription intervention
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
• Men between the ages of 50 and 90
• patient with non-metastatic or metastatic prostate cancer whose disease has been diagnosed based on examination and paraclinical procedures.
• No cardiovascular, cerebral, renal or hepatic problems.
• No history of hormone use, immunosuppressive drugs in the last 2 months
• No immune system diseases such as AIDS and .MS
• Able and willing to sign informed consent form;
Exclusion criteria:
• Sensitivity to drugs, especially GnRH-A
Previous history of chemotherapy
• Other diseases
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Intervention groups
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All volunteers are randomly divided into two groups after definitive confirmation of non-metastatic or metastatic prostate cancer and one group will receive 11.25 mg of extended-release injectable variopeptyl and the other group will receive 11.25 mg of injectable extended-release drug diphererline.
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Main outcome variables
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measurement of serum triptorelin concentration
General information
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Reason for update
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Changes in the study population
(According to the principal investigator, the number of people with non-metastatic prostate cancer is very limited, so it is necessary to increase the age range of patients participating in the study from 50 to 70 years to 50 to 90 years. Also adding the population of patients with metastatic prostate cancer to the inclusion criteria).
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170225032759N3
Registration date:
2021-04-06, 1400/01/17
Registration timing:
prospective
Last update:
2023-04-11, 1402/01/22
Update count:
3
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Registration date
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2021-04-06, 1400/01/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-02-26, 1400/12/07
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Expected recruitment end date
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2022-07-23, 1401/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparative bioequivalency study (pharmacokinetics- pharmacodynamics) of Variopeptyl® 11.25 mg and Diphereline® 11.25 mg in Patients with non-metastatic or metastatic prostate cancer Volunteers
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Public title
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Comparative bioequivalency study (pharmacokinetics-pharmacodynamics) of Variopeptyl® 11.25 mg and Diphereline® 11.25 mg in Patients with non-metastatic or metastatic prostate cancer Volunteers
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
• Men between the ages of 50 and 90
• patient with non-metastatic or metastatic prostate cancer whose disease has been diagnosed based on examination and paraclinical procedures.
• Without cardiovascular, cerebral, renal and liver problems.
• No history of hormone use, immunosuppressive drugs in the last 2 months
• No immune system diseases such as AIDS and MS
• Able and willing to sign informed consent form
Exclusion criteria:
• Sensitivity to drugs, especially GnRH-A
• Previous history of chemotherapy
• Other diseases
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Age
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From 50 years old to 90 years old
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Gender
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Male
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Phase
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Bioequivalence
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Groups that have been masked
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is based on randomized classification blocks.
The randomization sequence will be created using the RandBETWEEN in Excel program.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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People who in this study will be unaware of the type of intervention prescribed to patients participating in the study are:
•Patient
• Principal Investigator (Physician)
The person who is aware of the type of intervention prescribed to patients in this study is the central staff that patients will refer to during the previous coordination, and based on the random allocation list, one of the two interventions will be prescribed for them.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-03-09, 1399/12/19
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Ethics committee reference number
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IR.MUI.MED.REC.1399.1142
Health conditions studied
1
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Description of health condition studied
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non-metastatic or metastatic prostate cancer
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Measurement of triptorelin concentration
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Timepoint
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at the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
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Method of measurement
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[D-Trp6]-LHRH
Secondary outcomes
1
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Description
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Measurement of PSA level
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Timepoint
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At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
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Method of measurement
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PSA tumor marker (ng/ml)
2
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Description
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Measurement of serum testosterone
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Timepoint
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At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
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Method of measurement
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RIA
3
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Description
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Measurement of serum FSH
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Timepoint
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At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
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Method of measurement
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RIA
Intervention groups
1
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Description
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Intervention group: ِDiphereline 11.25 mg single dose for 3 months
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Variopeptyl 11.25 mg single dose for 3 months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Varian Pharmed Co
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available