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CTRI Number  CTRI/2020/10/028442 [Registered on: 16/10/2020] Trial Registered Prospectively
Last Modified On: 17/09/2021
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Open label multicenter randomized parallel single-period single dose bio equivalence study of Leuprolide acetate 30 mg in adult male subjects with advanced prostatic cancer undergoing initial therapy.  
Scientific Title of Study   An open label, multicenter, balanced, randomized, parallel, two-treatment, single-period, single dose bioequivalence study of Leuprolide acetate 30 mg of Pharmathen S.A., Greece with LUPRON DEPOT (leuprolide acetate for depot suspension) 30 mg of AbbVie Inc. North Chicago, IL 60064 in adult male subjects with advanced prostatic cancer undergoing initial therapy under fasting conditions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
20-VIN-0131  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumit Arora 
Designation  Head Clinical Operations 
Affiliation  Veeda Clinical Research Pvt. Ltd  
Address  Veeda Clinical Research Pvt. Ltd Shivalik Plaza, Near I.I.M. Ambawadi

Ahmadabad
GUJARAT
380015
India 
Phone  7930013000  
Fax  7930013010  
Email  Sumit.arora@veedacr.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Alamchandani 
Designation  Dy. General Manager 
Affiliation  Veeda Clinical Research Pvt. Ltd 
Address  Veeda Clinical Research Pvt. Ltd Shivalik Plaza, Near I.I.M. Ambawadi

Ahmadabad
GUJARAT
380015
India 
Phone  7930013000  
Fax  7930013010  
Email  Ravi.A1950@veedacr.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravi Alamchandani 
Designation  Dy. General Manager 
Affiliation  Veeda Clinical Research Pvt. Ltd 
Address  Veeda Clinical Research Pvt. Ltd Shivalik Plaza, Near I.I.M. Ambawadi


GUJARAT
380015
India 
Phone  7930013000  
Fax  7930013010  
Email  Ravi.A1950@veedacr.com  
 
Source of Monetary or Material Support  
Pharmathen S.A Greece 
 
Primary Sponsor  
Name  Pharmathen SA  
Address  Pharmathen S.A 44 Kifissias Ave. 15125 Marousi Attica Greece 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinay Kumar  GSVM Medical College  Department of Surgery, Swaroop Nagar Kanpur 208002 U P
Kanpur Nagar
UTTAR PRADESH 		 09660640989

Vinaysinghkgmc99@gmail.com 
Dr Rajnish Nagarkar  HCG Manavata Cancer Centre   Behind Shivang Auto Mumbai Naka Nashik 422002 Maharashtra India
Nashik
MAHARASHTRA 		 09823061929

drraj@manavatacancercentre.com 
Dr Prakash S S   K R Hospital Mysore Medical College and Research Institute  Dept. of Surgical Oncology, Clinical Research Room, Next to NSB 12, 2nd Floor, New Surgical Block, Mysore 570001 Karnataka
Mysore
KARNATAKA 		 09901000559

Prakashyesyes@yahoo.com 
Dr Saurabh Rajeshwar Prasad   Kingsway Hospitals   44 Parwana Bhawan Kingsway Nagpur Maharashtra 440001
Nagpur
MAHARASHTRA 		 7066580511

drsaurabhprasad@gmail.com 
Dr Arvind Ganpule  Muljibhai Patel Urological Hospital  Dr. Virendra Desai Road, Nadiad, Gujarat - 387001
Kheda
GUJARAT 		 8866286477

doctorarvind1@gmail.com 
Dr Jayanti Patel  Nirmal Hospital Pvt Ltd  Ring Road Surat 395002 Gujarat India
Surat
GUJARAT 		 08141397388

pateldrjayanti@gmail.com 
Dr Vaibhav Chaudhary  RST Tertiary Care Cancer Centre  Tukdoji Square Manewada Road Nagpur Maharashtra 440027
Nagpur
MAHARASHTRA 		 09833621049

drvaibhav155@gmail.com 
Dr Mukesh Arya  S P Medical College and AG of Hospitals  Dept of Urology, Uroscience Centre, Bikaner - 334003, Rajasthan
Bikaner
RAJASTHAN 		 09782300231

mcarya@yahoo.co.in 
Dr Aniket Thoke  Sanjeevani CBCC USA Cancer Hospital  Infront of Jain Mandir Dawada Colony Pachpedi Naka Raipur 492001 Chhattisgarh
Raipur
CHHATTISGARH 		 9752929741

drthoke@gmail.com 
Dr Dhruv Mehta  Tristar Hospital  Opp T and TV High School Athwa Gate Surat Gujarat 395001
Surat
GUJARAT 		 09727053929

dr.dhruv.mehta14@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee GSVM Medical College  Approved 
Ethics Committee, S.P. Medical College and AG of Hospital   Approved 
Ethics Committee, Sanjeevani Cancer Hospital  Approved 
IEC MMC and RIE Associated Hospitals  Approved 
Institutional Ethics Committee, RST Tertiary Care Cancer Centre  Approved 
Kingsway Hospitals Ethics Committee  Approved 
Manavata Clinical Research Institute Ethics Committee  Approved 
Muljibhai Patel Urological Hospital Dr. Virendra Desai road Nadiad Nadiad Ethics committe  Approved 
Nirmal Hospital Ethics Committee  Approved 
Tristar Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N429||Disorder of prostate, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Leuprolide Acetate 30 mg intramuscular injection for Depot Suspension   Leuprolide Acetate 30 mg intramuscular injection for Depot Suspension of Pharmathen S.A. Greece in adult male subjects with advanced prostatic cancer  
Comparator Agent  LUPRON DEPOT (Leuprolide Acetate for Depot Suspension) 30 mg of AbbVie Inc. North Chicago IL 60064  LUPRON DEPOT (leuprolide acetate for depot suspension) 30 mg of AbbVie Inc.in adult male subjects with advanced prostatic cancer 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  1. Male patients having a BMI of 18.5-30 kg/m2 (both inclusive).
2. Ability to understand and provide written informed consent prior to participation in the study and willing to comply with the study requirements as per protocol.
3. Patients who require Leuprolide Acetate Depot Injection, 30mg, every 16 weeks.
4. Patients with histologically/cytologically confirmed advanced carcinoma of prostate (Stage T(1b-4), N(any) , M(any)) who would be benefit from GnRH agonist.
5. Newly diagnosed advanced prostatic cancer patients that are scheduled to receive their first dose of leuprolide acetate as a part of their standard of care.
6. Testosterone levels ≥1.5ng/mL at screening.
7. Patients with an ECOG Performance Status Score < 2
8. Patients with hemoglobin ≥ 9.0 g/dL.
9. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
10. Patients with HbA1c ≤ 7 % at screening
11. Patients with life expectancy of at least 6 months at the time of enrolment as judged by Investigator.
12. Patients/ partner agreeing to use adequate contraceptive methods during the study.
 
 
ExclusionCriteria 
Details  1.Known hypersensitivity or contraindication to GnRH, GnRH agonist or to any of the components of investigational product.
2.History of prostatic surgery (e.g., radical prostatectomy, transurethral resection of the prostate [TUR-P]), orchiectomy, adrenalectomy and hypophysectomy.
3.History of radiotherapy, chemotherapy, immunotherapy, radiation therapy, cryotherapy, strontium, or biological response modifiers as prostate therapy within 8 weeks prior the screening visit.
4.Patients that received hormonal manipulation within 32 weeks prior the screening visit (i.e. GnRH analogues, estrogen, megace and phytotherapy)
5.Patients requiring additional treatment (i.e. radiotherapy)
6.History of hypogonadism
7.Received therapy with finasteride or ketoconazole within 1 week prior to the Screening Visit; dutasteride within 25 weeks prior to the Screening Visit.
8.Received therapy with a GnRH analog (1 year implant) within 60 weeks prior to the Screening Visit.
9.Positive tests for drug or alcohol abuse at screening or baseline.
10.Patient had major surgery (other than those specified in criteria 2) within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
11.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
12.Is either a non-smoker or ex-smoker who has not used any nicotine containing products in the last 6 months before day 1 of study treatment.
13.History of difficulty with donating blood or difficulty in accessibility of veins.
14.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
15.Clinical indication of urinary tract obstruction.
16.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.)
17.Significant pre-existing cardiovascular co morbidities i.e.
• Myocardial infarction within 6 month
• Unstable angina
• Congestive cardiac failure
• Cardiac arrhythmia
• History of familial long QT syndrome
18.Known CNS metastasis.
19.Patients having history of convulsion, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs.
20.Concurrent medications that may prolong the QT/QTc interval.
21.A marked baseline prolongation of QTc interval (QTc interval >450 milliseconds (ms))
22.History of other malignancies in the last 5 years (except in situ cancer of cervix or basal or squamous cell skin cancer).
23.Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product.
24.Any condition/ abnormal baseline findings that in the investigator’s judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study e.g. low expectation of compliance to dosing or expected changes in concomitant medication that may interfere in study.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the bioequivalence between Leuprolide acetate 30 mg of Pharmathen S.A., Greece and LUPRON DEPOT (leuprolide acetate for depot suspension) 30 mg of AbbVie Inc. North Chicago, IL 60064 in adult male subjects with advanced prostatic cancer undergoing initial therapy under fasting conditions.  A total of 36 pharmacokinetic blood samples will be collected per patient the during study. All PK samples after 24.00hrs. will be ambulatory. Visit 3-21: Ambulatory PK sample collection visit (on days 3, 4, 7, 11, 15, 19, 23, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105) Visit 22: End of study visit: Ambulatory PK sample collection visit (on day 112) and safety assessment. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to ensure the safety of
patients exposed Investigational Medicinal Product. 		 Patients will be monitored for safety at screening period of 14 days and study duration post randomization for at least 112 days. Each patient will have 22 visits during the study. Visit 1: Screening visit (14 days prior to first day of dosing)Visit 2: Eligibility / Randomization visit (check in day 0) and Visit 22: End of study visit: Ambulatory PK sample collection visit (on day 112) and safety assessment. 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/10/2020 
Date of Study Completion (India) 10/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Patients requiring dose of Leuprolide acetate depot 30 mg intramuscular injection once every 16 weeks will be enrolled in the parallel design study. If the patient is found suitable for the study enrollment based on the eligiblity assessment , patient will be randomized to receive single dose of leuprolide acetate depot 30 mg intramuscular injection (either the test or reference product) on day 1 as per the randomization schedule.
Total 36 PK samples will be collected per patient in the study.
All PK samples after 24 hrs will be ambulatory. 
Serum concentration of leuprolide will be quantified using validated analytical methods.
Statistical analysis of PK parameters of test and or reference formulations will be performed using SAS version 9.04 or higher to assess bioequivqlence.


 
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