Status:
COMPLETED
Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer
Lead Sponsor:
Bharat Serums and Vaccines Limited
Conditions:
Advanced Prostate Adenocarcinoma
Eligibility:
MALE
18-99 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2022
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT04914195
Start Date
July 1 2021
End Date
September 29 2022
Last Update
August 1 2023
Active Locations (2)
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1
Government Med ical College & Superspeciality Hospital Nagpur
Nagpur, Maharashtra, India, 440009
2
MV hospital and Research Center
Lucknow, Uttar Pradesh, India, 226003