- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04914195
Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer
Efficacy, Safety, and Pharmaco-kinetics of Leuprolide Acetate for Injection 3.75mg (Depot) (Leuprorelin) Administered in Subjects With Advanced Adenocarcinoma of Prostate: A Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3 Study
This is a Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3 clinical study to compare the efficacy, safety, and pharmacokinetics of leuprolide acetate for injection 3.75mg (depot) of two brands (Luprodex and Lucrin) administered in subjects with advanced adenocarcinoma of the prostate.
Approximately 168 subjects (males )of age above 18 years fulfilling the eligibility criteria will be enrolled. The IP will be given as a monthly dose for two cycles on day 0 and day 28.
The pharmacokinetic analysis will be done for 12 patients receiving Luprodex. The primary and secondary outcomes will be captured on days as per protocol. Adverse events will be noted for safety evaluation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Prashant Mehrotra
- Phone Number: 91-022-45043456
- Email: CR@bharatserums.com
Study Locations
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Maharashtra
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Nagpur, Maharashtra, India, 440009
- Government Med ical College & Superspeciality Hospital Nagpur
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226003
- MV hospital and Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male subjects aged above 18 years.
- Histologically or cytologically confirmed adenocarcinoma of the prostate at stage T1b-4, Nany, Many in subjects, who would benefit from a GnRH agonist.
- Baseline Testosterone of >1.50 ng/mL or >150 ng/dL.
- For subjects with radical prostatectomy, an increase of 0.2 ng/mL or 20 ng/dL in PSA from previous test on two consecutive tests. For subjects with prostate irradiation a rise of greater than or equal to 2.0 ng/mL or 200 ng/dL PSA above the nadir.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix 2).
- Life expectancy of at least 6 months from screening.
- Adequate organ and immune system function
- Willing to participate and sign the informed consent as per regulatory requirements.
Exclusion Criteria:
- Evidence of brain metastases.
- Evidence of spinal cord compression.
- Evidence of urinary tract obstruction, where a flare in disease could put subject at significant risk in the opinion of the Investigator.
- Received prostate cancer therapies like immunotherapy (antibody therapies, tumor vaccines), external radiotherapy, brachytherapy, chemotherapy or biological response modifiers (e.g. cytokines) within two months of enrollment.
- Undergone any prostate surgery (e.g. transurethral resection of the prostate (TURP), radical prostatectomy) within two weeks of enrollment.
- Under the effects of any other hormonal therapy, including anti-androgens for treatment of prostate cancer within three months of baseline.
- Received leuprolide (leuprorelin) previously.
- Had an orchiectomy, adrenalectomy or hypophysectomy.
- Had used any investigational drug, biologic, or device within five half-lives of its physiological action or three months, whichever is longer, before enrollment.
- Anticipated to need concomitant hormonal, anti-androgen, radiotherapy, chemotherapy, immunotherapy or surgical therapy for prostate cancer throughout the duration of the study.
- Used over-the-counter (OTC) or alternative medical therapies which has an estrogenic or anti-androgenic effect (e.g., Glycyrrhiza, Dehydroepiandrosterone (DHEA), PC-SPES, saw palmetto) within three months prior to enrollment.
- Used finasteride, dutasteride, estrogens, megestrol acetate, anti-androgens (Bicalutamide, Flutamide, or Cyproterone), and ketoconazole within three months prior to baseline.
- Co-existent malignancy or a history of malignancy, with the exception of basal and/or squamous cell carcinomas of the skin.
- Uncontrolled congestive heart failure within six months before baseline.
- Experienced a myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft surgery) within six months before baseline.
- Significant symptomatic cardiovascular disease within six months of baseline.
- Experienced venous thrombosis within six months of baseline.
- Uncontrolled hypertension (≥160/100 mmHg) or symptomatic hypotension within three months before baseline.
- Insulin-dependent diabetes mellitus (Type I diabetes mellitus).
- History of drug abuse within six months of baseline.
- Serious intercurrent illnesses or diseases (e.g. hematological, renal, hepatic, respiratory, endocrine, psychiatric) that might interfere with the treatment outlined in the protocol.
- Receiving anticoagulants or antiplatelet medications and not receiving a stable dose for three months before baseline. Receiving warfarin-derivative anticoagulants with International normalized ratio (INR) outside therapeutic range for the clinical indication for which the anticoagulant has been prescribed.
- Known hypersensitivity to GnRH, GnRH agonists or any excipients of Leuprolide (leuprorelin).
- Positive test for HIV, HCV, HbsAg at Screening.
History of:
- Immunization within four weeks of baseline
- Flu shots within two weeks of baseline
- Donation or receipt of blood or blood products within two months of baseline
- Anaphylaxis
- Skin disease which would interfere with injection site evaluation
- Dermatographism (Physical urticaria).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Leuprolide acetate 3.75 mg Depot (Luprodex)
Will be administered subcutaneously once a month for two cycles, on day 0 and on day 28/29
|
Leuprolide Acetate/ Leuprorelin is a depot injection administered as a subcutaneous injection once every month.
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Active Comparator: Leuprolide acetate 3.75 mg Depot (Lucrin)
Will be administered subcutaneously once a month for two cycles, on day 0 and on day 28/29
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Leuprolide Acetate/ Leuprorelin is a depot injection administered as a subcutaneous injection once every month.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Testosterone response rate defined as Testosterone values sustained below castration level (0.5 ng/mL or 50 ng/dL) i.e. all Testosterone values at and after Day 28 until Day 57 must be < 0.5 ng/mL or < 50 ng/dL
Time Frame: From Day 28 to day 57
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From Day 28 to day 57
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of subjects who have reached castration level of Testosterone at the last visit (Day 57)
Time Frame: Day 57
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Day 57
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Percentage of breakthrough responses defined as a single total serum Testosterone value of >0.5 ng/mL or >50 ng/dL measured after achieving a castration Testosterone level
Time Frame: from Day 28 to Day 57
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from Day 28 to Day 57
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Time after first implantation until castration level of Testosterone is achieved
Time Frame: up to Day 28
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up to Day 28
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Percentage of subjects with Testosterone values sustained below 0.2 ng/mL or 20 ng/dL at and after Day 28 until Day 57
Time Frame: From Day 28 to Day 57
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From Day 28 to Day 57
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Change from baseline in Luteinizing hormone (LH) levels at Day 28 and 57
Time Frame: from baseline to Day 28 and from baseline to Day 57
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from baseline to Day 28 and from baseline to Day 57
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Change from baseline in Follicle Stimulating Hormone (FSH) levels at Day 28 and Day 57
Time Frame: from baseline to Day 28 and from baseline to Day 57
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from baseline to Day 28 and from baseline to Day 57
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Change from baseline in Prostate-specific antigen (PSA) at Day 57
Time Frame: Day 57
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Day 57
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Mean number of days of maintaining testosterone castration levels (mean number of castration days)
Time Frame: day 28 to day 57
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day 28 to day 57
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Mean maximum testosterone concentration during the dosing period after reaching the castration level
Time Frame: Day 28 to Day 57
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Day 28 to Day 57
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Collaborators and Investigators
Investigators
- Principal Investigator: Anirban Roy Chowdhury, Bharat Serums and Vaccines Ltd
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSV_LEUPR_18_05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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