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

NCT04914195 | Completed Phase 3

• 1 other identifier: BSV_LEUPR_18_05
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 2

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 (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.

Conditions

Advanced Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  From Day 28 to day 57

Secondary Outcomes (9)

• Percentage of subjects who have reached castration level of Testosterone at the last visit (Day 57)

  Day 57

• 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

  from Day 28 to Day 57

• Time after first implantation until castration level of Testosterone is achieved

  up to Day 28

• Percentage of subjects with Testosterone values sustained below 0.2 ng/mL or 20 ng/dL at and after Day 28 until Day 57

  From Day 28 to Day 57

• Change from baseline in Luteinizing hormone (LH) levels at Day 28 and 57

  from baseline to Day 28 and from baseline to Day 57

Study Arms (2)

Leuprolide acetate 3.75 mg Depot (Luprodex)

EXPERIMENTAL

Will be administered subcutaneously once a month for two cycles, on day 0 and on day 28/29

Drug: Leuprolide Acetate 3.75 MG/ML

Leuprolide acetate 3.75 mg Depot (Lucrin)

ACTIVE COMPARATOR

Will be administered subcutaneously once a month for two cycles, on day 0 and on day 28/29

Drug: Leuprolide Acetate 3.75 MG/ML

Interventions

Leuprolide Acetate 3.75 MG/ML DRUG

Leuprolide Acetate/ Leuprorelin is a depot injection administered as a subcutaneous injection once every month.

Leuprolide acetate 3.75 mg Depot (Lucrin); Leuprolide acetate 3.75 mg Depot (Luprodex)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bharat Serums and Vaccines Limited: lead

Study Sites (2)

Government Med ical College & Superspeciality Hospital Nagpur

Nagpur, Maharashtra, 440009, India

Location

MV hospital and Research Center

Lucknow, Uttar Pradesh, 226003, India

Location

MeSH Terms

Interventions

Leuprolide

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Anirban Roy Chowdhury

  Bharat Serums and Vaccines Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 4, 2021
• Study Start: July 1, 2021
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

IN (2)