Safety and Efficacy Study of Leuprolide Acetate for Injectable Suspension 22.5 MG in the Treatment of Prostate Cancer

NCT00598312 | Completed Phase 3

• 1 other identifier: OL-01110
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients with prostate cancer.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The percentage of responders who attain and maintain castrate levels of serum testosterone

  From Day 28 to Day 168.

Secondary Outcomes (3)

• Safety as shown through laboratory parameters

  Day 0 - Day 168

• Leuprolide serum profiles following administration study drug product.

  Day 0 - Day 168

• Safety as shown through reported adverse events

  Day 0 -168

Interventions

Leuprolide Acetate for Injectable Suspension DRUG

Sustained release injectable microspheres, 22.5 mg, one injection every 84 days, 3-month product

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reads, understands and is able and willing to sign informed consent form
• Males greater than or equal to age 45
• Histologically and cytologically documented prostate carcinoma
• Candidate for initial hormone therapy - inclusive of patients beginning neoadjuvant or intermittent therapy, being treated locally for advanced disease, or patients beginning therapy for failure of prior local therapy
• Patients who have had prior LHRH therapy in an adjuvant or neoadjuvant setting, providing that the last date of effective therapy was greater than 6 months prior to screening
• ECOG 0-2
• Morning serum testosterone level \> 150 ng/dL
• Standard screening labs within 2x ULN (AST, ALT, bilirubin and serum creatinine)
• Hemoglobin \> 10 g/dL
• Life expectancy of \>1yr.
• Willing to complete both cycles and all procedures of the study

You may not qualify if:

• Any prior (except for prior LHRH therapy in an adjuvant or neoadjuvant setting) or current definitive therapy for prostate cancer, including chemotherapy, immunotherapy, tumor-vaccines,biological response modifiers, or estrogens
• Patients who have undergone any prostatic surgery within 4 weeks of Baseline
• Patients who have undergone orchiectomy, adrenalectomy, or hypophysectomy
• Patients that are currently hospitalized or require frequent hospitalization
• Prior resistance to LHRH therapy, either neoadjuvant or adjuvant.
• Patients with evidence of spinal cord compression, ureteral obstruction or clinically significant bladder outlet obstruction
• Participation in any investigational drug, biologic, or device study within five half-lives of its physiological action or three months prior to enrollment, whichever was longer
• Patients anticipated to need concomitant hormonal, anti-androgen, radio-, chemo-, immuno- or surgical therapy for prostate cancer while on study
• History of recent drug and/or alcohol abuse within 6 months of screening
• History of HIV, HCV or HBV infection
• History of hypersensitivity or known allergy to LHRH agonists or antagonists
• Concurrent use of daily corticosteroids or other agents known to modify serum androgen within 12 weeks of screening visit
• Patients on other anti-androgens such as flutamide, nilutamide or bicalutamide
• History of other cancer with the exception of non-metastatic basal or squamous cell carcinoma of the skin
• Patients receiving any type of 5-alpha reductase inhibitor such as Proscar, Propecia, or Avodart within the past 3 months

Sponsors & Collaborators

• Oakwood Laboratories, LLC: lead

Study Sites (1)

Oakwood Laboratories, LLC

Oakwood Village, Ohio, 44146, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

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

• Daniel Saltzstein, MD

  Urology San Antonio Research PA

  PRINCIPAL INVESTIGATOR

• James Page, MD

  Oakwood Laboratories, LLC

  STUDY CHAIR

• Beth Glasgow

  Oakwood Laboratories, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 21, 2008
• Study Start: April 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 8, 2010

Record last verified: 2010-09

Locations

US (1)