Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer

  • STATUS
    Recruiting
  • days left to enroll
    77
  • participants needed
    168
  • sponsor
    Bharat Serums and Vaccines Limited
Updated on 11 August 2022

Summary

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.

Details
Condition Advanced Prostate Adenocarcinoma
Treatment Leuprolide Acetate 3.75 MG/ML
Clinical Study IdentifierNCT04914195
SponsorBharat Serums and Vaccines Limited
Last Modified on11 August 2022

Eligibility

Yes No Not Sure

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)
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