CTRI/2025/09/094579 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On:
08/05/2026
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Study of Leuprolide Acetate for Depot Suspension (30 mg For 4-Month, 16 Weeks) in Adult Male Prostatic Carcinoma Participants.
Scientific Title of Study
An Open Label, Multi-Center, Randomized, Single-Dose, Balanced, Two-Treatment, Parallel, Pharmacokinetic Bioequivalence Study of Leuprolide Acetate for Depot Suspension (30 mg For 4-Month, 16 Weeks) of American Regent, Inc. with Lupron Depot (Leuprolide Acetate for Depot Suspension 30 mg For 4-Month, 16 Weeks) of Abbvie Inc. North Chicago, IL 60064 in Adult Male Prostatic Carcinoma Participants Undergoing Initial Therapy or Receiving a Stable Regimen of Leuprolide Acetate.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No .: C2A05649 Version: 01 Date: 29 May 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad – 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
0792717693500
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate Director- II– Clinical Trial Medical Services
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad – 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
0792717693500
Fax
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Jitendra Panda
Designation
Senior Project Manager - Clinical Trials
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad – 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
0792717693500
Fax
Email
jpanda@cliantha.com
Source of Monetary or Material Support
American Regent, Inc., 6610 New Albany Rd E, New Albany, OH 43054, United States
Primary Sponsor
Name
American Regent, Inc.
Address
6610 New Albany Rd E, New Albany, OH 43054, United States
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Cliantha Research Limited
Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
1st Floor, HOD Room, Main Building, Jotiakhali, Fulbari, Jalpaiguri - 734015, West Bengal Jalpaiguri WEST BENGAL
8106572241
drsaptarshi10@gmail.com
Dr Deepak Singla
Indus International Hospital
Near Jawaharpur, Chandigarh - Ambala Road, National HighwayNo.22, Derabassi, Mohali, Punjab – 140507 Patiala PUNJAB
9755672355
deepak.singla02@gmail.com
Dr Prakash SS
K.R. Hospital, Mysore Medical College and Research Institute
Dept. of Surgical Oncology, Ground floor, Room No. 23, Next to Dept. Radiology, Irwin Road, Mysore - 570001, Karnataka, India Mysore KARNATAKA
9901000559
prakashyesyes@yahoo.com
Dr Vishal Kulkarni
Karnataka Medical College And Research Institute
Clinical trail department,room no.23,Department of mediacal oncology, 2dn floor, PMSSY building, Office of the Principal Vidyanagar, Hubballi, Dharwad - 580021, Karnataka, India
Dharwad KARNATAKA
8660434729
drvishalkulkarani@gmail.com
Dr Satish Sonawane
Maccare Superspeciality Hospital
Behind Zopadi Canteen, Opp St Moica D.ed College, Savedi, Ahmednagar - 414003, Maharashtra Ahmadnagar MAHARASHTRA
973099999
satishujjwal@yahoo.com
Dr Mule Tushar Rajendra
Marathwada Cancer Hospital and Research institue
Plot no. 2, Dyaneshwar nagar in front of stadium, Garkheda, Aurangabad - 431001, Maharashtra, India Aurangabad MAHARASHTRA
9820493558
drtusharmchri@gmail.com
Dr Dev Kumar Yadav
Moti Lal Nehru Medical College
Department of Cancer and Radiation Oncology, Lowther Road, George Town, Prayagraj - 211002, Uttar Pradesh, India Allahabad UTTAR PRADESH
9453287304
devkumar108@gamil.com
Dr Rahul Chaudhary
N.M. Virani Wockhardt Hospital
Office No. 52, Clinical Research Department, Kalavad Road, Beside St. Merry School, Rajkot - 360007, Gujarat Rajkot GUJARAT
8160292657
rahul31in@yahoo.com
Dr Suman Ghorai
Nil Ratan Sircar Medical College
138, 2nd floor, A.J.C Bose Road, Kolkata - 700014, West Bengal Kolkata WEST BENGAL
9830169939
ghoraisuman199@gmail.com
Dr Satyaveer Singh
Onco Care Cancer And Super Specialty Hospital
Room Number 03, Basement Clinical Research Department, Near Joya Toll Plaza, NH-24, Amroha Amroha, Moradabad, Uttar Pradesh - 244222, India
Moradabad UTTAR PRADESH
9758449955
veer.satya009@gmail.com
Dr Anil Kumar MR
Oncoville Cancer Hospital and Research Centre
Department of Radiation Oncology, Clinical Trial Division, Third Floor, No. 4, 80 Ft. Road, 7th Block, Nagarbhavi 2nd Stage, Bengaluru - 560072, Karnataka, India Bangalore KARNATAKA
9739808502
dranil.onco@gmail.com
Dr Prem Kumar
Ranchi Urology Centre
Buxi Compound, Behind Indian Oil Petrol Pump, Bariatu, Ranchi - 834009 Ranchi JHARKHAND
Institutional Ethics Committee, Hope And Heal Cancer Hospital And Research Centre
Approved
Institutional Ethics Committee, MLN Medical College
Approved
Institutional Ethics Committee, MMC and RI and Associated Hospital
Approved
Institutional Ethics Committee, S S Hospital and Research Centre
Approved
Institutional Ethics Committee,OCH and RC
Approved
Institutional Ethics Committee,Uttar Pradesh University of Medical Sciences
Approved
Institutional Ethics Committee-Clinical Research and Studies(IEC-CRS) SUM ULTIMATE MEDICARE
Approved
KKMH institutional ethics committee
Approved
KMCRI ETHICS COMMITTEE
Approved
Manavata Clinical Research Institute Ethics Committee
Approved
Netaji Polyclinic Institutional Ethics Committee
Approved
PP Maniya Hospital Ethics Committee
Approved
Regency Hospital Ethics Committee
Approved
Signus Hospital Ethics Committee
Approved
Spandan hospital Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C61||Malignant neoplasm of prostate,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Leuprolide Acetate for Depot Suspension (30 mg For 4-Month, 16 Weeks) of American Regent, Inc.
30 mg depot suspension for single dose, 30 mg for 4-month, 16 Weeks
Comparator Agent
Lupron Depot (leuprolide acetate for depot suspension for Intramuscular injection; (30 mg for 4-month, 16-weeks) Manufactured for AbbVie Inc.
Leuprolide acetate for depot suspension; 30 mg for 4- month, 16 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Male
Details
1. Willing and able to provide voluntary informed consent prior to commencement of any study-related activities, and the ability to follow protocol requirements
2. Male participants aged 18 years and older and having body mass index (BMI) between 18.00 to 30.00 kg/m2 (both inclusive) at the screening visit
3. Male participants with histologically/cytologically confirmed carcinoma of the prostate
4. Participants in the PI judgement who are eligible or require leuprolide acetate long-acting depot injection (30 mg, 4-months)
5. Participants who,
a. newly diagnosed with locally advanced and/or metastatic prostate cancer (diagnosed within 6 months prior to screening and have not received any prior anticancer treatment) and scheduled to receive their first dose of leuprolide acetate as a part of their standard of care OR
b. already receiving a stable regimen of leuprolide acetate via intramuscular injection route and in the PI judgement are eligible for switching to longer duration dosage form such as 30 mg for every 4 months (16 weeks). Participants with histologically/cytologically confirmed advanced carcinoma of prostate (Stage T(1b-4), N(any), M(any)) who would benefit from GnRH agonist
Note: Participants with previous history of radical prostatectomy, trans urethral resection of the prostate (TUR-P) can be included. Participants should have complete recovery from surgery before screening
6. Eastern Cooperative Oncology Group (ECOG) performance status less than or equals to.
7. Acceptable hematology status
a. Hemoglobin greater than or equals to 9 g/dL
b. Absolute neutrophil count (ANC) greater than or equals to 1500 cells/mm3
c. Platelet count greater than or equals to 100,000 cells/mm3
8. Acceptable liver function:
a. Alanine aminotransferase (ALT) less than or equals to 2 x ULN (less than or equals to 5 x ULN if liver metastases present)
b. Aspartate aminotransferase (AST) less than or equals to 2 x ULN (less than or equals to 5 x ULN if liver metastases present)
c. Bilirubin less than or equals to 1.5 x ULN
d. Alkaline phosphatase less than or equals to 2 x ULN and less than or equals to 5 x ULN if bone metastasis is present
9. Participants with adequate renal function at screening as defined by serum creatinine less than 1.5 times ULN (Upper Limit of Normal) for the clinical laboratory
10. Participants with HbA1c less than or equals to 8 percent
11. Participants with life expectancy of at least 6 (six) months at the time of enrolment
12. Participants who wish to bank their semen must agree to semen banking prior to 24 hours of receiving the first dose of Investigational Product
13. Participants who agree to use adequate male contraceptive methods while in the study
ExclusionCriteria
Details
1. Known hypersensitivity or contraindication to gonadotropin-releasing hormone (GnRH), GnRH agonist or to any of the components of investigational product
2. History of prior prostatic surgery (e.g. orchidectomy, hypophysectomy or 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. Participants that received hormonal manipulation within 32 weeks prior to the screening visit (i.e. GnRH analogues except Leuprolide acetate formulations, estrogen, megace and phytotherapy)
5. Received therapy with a GnRH analogue (1 year implant) within 60 weeks prior to the screening visit
6. Indication of clinically significant urinary tract obstruction or spinal cord compression
7. History of any major surgical procedure (including periodontal) within 28 days prior to receiving an investigational product
8. Corrected QT interval [Fridericia formula (QTc)] greater than 450 msec at screening visit or before dosing
9. Concurrent medications that may prolong the QT/QTc interval
10. Presence of any uncontrolled systemic disease (e.g. cardiovascular disease Myocardial infarction within 6 months, Unstable angina, Congestive cardiac failure, Cardiac arrhythmia, History of familial long QT syndrome, hypertension, diabetes mellitus etc.)
11. Known history of CNS metastasis and other malignancies in the last 5 years (except in situ cancer of cervix or basal or squamous cell skin cancer).
12. Surgical or other non-healing wounds
13. Participants with positive serology for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV)
14. Participant with history or presence of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumours or participants who are on concomitant medications that have been associated with convulsions such as bupropion and Selective serotonin reuptake inhibitors (SSRIs)
15. Participants with positive urine screen for alcohol test or drugs of abuse
16. Smokers who smoke greater than or equals to 10 cigarettes or equivalents per week
17. Participants with history of Severe Cutaneous Adverse Reactions (SCARs) including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN)
18. Have not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational products used to treat cancer other than locally advanced and/or metastatic prostate cancer. Exceptions are alopecia (any grade is acceptable), hemoglobin greater than or equals to 9 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V 5.0)
19. Participation in any clinical study within 90 days prior to receiving the investigational product (IP) of the current study, excluding leuprolide acetate long-acting injectable products
20. Any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the participant to participate in the study, including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements
21. History of hypogonadism
22. Received therapy with finasteride or ketoconazole within 1 week prior to the screening visit; dutasteride within 25 weeks prior to the screening visit
23. Participants who had major surgery (other than those specified in criteria 2) within 4 weeks prior to the screening visit, or who have not recovered from prior major surgery
24. History of difficulty with donating blood or difficulty in accessibility of veins
25. 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 (except 30 days for the treatments with leuprolide acetate products)
26. History of addiction to any recreational drug or drug dependence or alcohol addiction within 12 months before the screening visit
27. Any condition/ abnormal baseline findings that in the investigators judgment might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to obtain objective of the study e.g. low expectation of compliance to dosing or expected changes in concomitant medication that may interfere in study
To establish bioequivalence between American Regent, Inc.s test formulation of Leuprolide acetate for depot suspension (30 mg for 4-month, 16 weeks) and the reference listed drug (RLD), Lupron Depot (leuprolide acetate for depot suspension; 30 mg for 4-month, 16 weeks) of AbbVie Inc. North Chicago, IL 60064 in adult male prostatic carcinoma participants undergoing initial therapy or receiving a stable regimen of leuprolide acetate administered via intramuscular injection route .
To assess the general safety & overall well-being of the study participants
16 weeks
Target Sample Size
Total Sample Size="850" Sample Size from India="850" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
18/12/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="8" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
An Open Label, Multi-Center,
Randomized, Single-Dose, Balanced, Two-Treatment, Parallel, Pharmacokinetic
Bioequivalence Study of Leuprolide Acetate for Depot Suspension (30 mg For
4-Month, 16 Weeks) of American Regent, Inc. with Lupron Depot (Leuprolide
Acetate for Depot Suspension; 30 mg For 4-Month, 16 Weeks) of Abbvie Inc. North
Chicago, IL 60064 in Adult Male Prostatic Carcinoma Participants Undergoing
Initial Therapy or Receiving a Stable Regimen of Leuprolide Acetate.
Objective:
1. To establish pharmacokinetics between American Regent,
Inc.s test formulation of Leuprolide acetate for depot suspension (30 mg for
4-month, 16 weeks) and the reference listed drug (RLD), Lupron Depot
(leuprolide acetate for depot suspension 30 mg for 4-month, 16 weeks) of
AbbVie Inc. North Chicago, IL 60064 in adult male prostatic carcinoma
participants undergoing initial therapy or receiving a stable regimen of
leuprolide acetate administered via intramuscular injection route. To
assess the safety of study products.
2. Qualitative comparison of the
pharmacodynamics markers (testosterone, PSA, LH and FSH) after the single dose
administration of the two formulations of leuprolide acetate for depot
suspension (30 mg for 4-month, 16-weeks) administered via intramuscular injection route (Test and RLD) in the study participant population.
3. To monitor the general safety
and tolerability of the leuprolide acetate for depot suspension
injections administered via intramuscular injection route in the study
participant populations.