Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer

NCT00128531 | Completed Phase 3

• 1 other identifier: CRO-04-62
• Study Type: interventional
• Target: 120
• Locations: 9 countries
• Sites: 28

Brief Summary

The purpose of this study is to look at the efficacy and safety of leuprolide acetate in patients with prostate cancer.

Conditions

Prostate Cancer

Keywords

Phase III; open label; multiple dose; safety study; pharmacokinetic study; efficacy study

Outcome Measures

Primary Outcomes (4)

• Efficacy: to determine the proportion of patients achieving castration levels of plasma testosterone (defined as <0.5 ng/mL) 4 weeks after the first administration

• to determine the proportion of patients maintaining castration levels of plasma testosterone from week 4 to study end

• to determine the proportion of patients showing acute rises in plasma testosterone levels upon repeated dosing from week 4 to study end

• Safety: evaluation of the safety of the new formulation based on adverse events (AEs), local tolerability, vital signs, electrocardiograms (ECGs), and clinical parameters

Secondary Outcomes (2)

• Efficacy: determination of serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), and prostate-specific antigen (PSA) concentrations

• World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status, bone pain, urinary symptoms and urinary pain after administration

Interventions

leuprolide acetate DRUG

Eligibility Criteria

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

You may qualify if:

• Males \>/= 18 years of age, with histologically proven carcinoma of the prostate, who might benefit from medical androgen deprivation therapy
• Life expectancy of at least 1 year
• World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1, or 2
• Adequate renal function at screening as defined by serum creatinine \</= 1.6 times the ULN (upper limit of normal) for the clinical laboratory
• Adequate and stable hepatic function as defined by bilirubin \</= 1.5 times the ULN and transaminases (i.e. SGOT, SGPT) \</= 2.5 times the ULN for the clinical laboratory at screening
• Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study

You may not qualify if:

• Evidence of brain metastases, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms
• Evidence of spinal cord compression, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms
• Evidence of severe urinary tract obstruction with threatening urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms
• Excruciating, severe pain from extensive osseous deposits, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms
• Testosterone levels \< 1.5 ng/mL at screening, locally determined at the laboratory of each clinical site
• Previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g. antibody therapies, tumor-vaccines), biological response modifiers (e.g. cytokines) within 3 months of baseline
• Previous hormonal therapy for treatment of prostate cancer, such as luteinising hormone-releasing hormone (LHRH) analogues (e.g. Lupron®, Zoladex®, etc.) \[no wash-out allowed\]
• Previous treatment with androgen receptor (AR) blockers, such as Casodex®, Fugerel®, Megace®, Androcur® (no wash-out allowed)
• Previous orchiectomy, adrenalectomy or hypophysectomy
• Previous prostatic surgery (e.g. radical prostatectomy, transurethral resection of the prostate \[TUR-P\]) within 2 weeks of baseline
• Previous local therapy to the primary tumor with a curative attempt other than surgery (external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy) within 2 weeks of baseline
• Any investigational drug within 5 half-lives of its physiological action or 3 months (whichever is longer) before baseline
• Administration of 5-alpha-reductase inhibitors (Proscar®, Avodart®, Propecia®) within 3 months before baseline
• Over-the-counter (OTC) or alternative medical therapies which have an estrogenic or anti-androgenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza®, Urinozinc®, dehydroepiandrosterone \[DHEA\]) within the 3 months before baseline
• Hematological parameters (RBC, total and differential WBC count, platelet count, hemoglobin, hematocrit) outside 20% of the upper or lower limits of normal (ULN, LLN) for the clinical laboratory at screening

Sponsors & Collaborators

• GP-Pharm: lead

Study Sites (28)

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

Desert Oasis Cancer Center

Casa Granda, Arizona, 85222, United States

Location

Southwest Florida Urologic Associates

Fort Myers, Florida, 33907, United States

Location

Advanced Research Institute, Inc.

New Port Richey, Florida, 34652, United States

Location

Florida Urology Specialists

Sarasota, Florida, 34237, United States

Location

Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Lakeside Urology

Saint Joseph, Michigan, 49085, United States

Location

Hamilton Urology, P.A.

Hamilton, New Jersey, 08690, United States

Location

Lawrenceville Urology

Lawrenceville, New Jersey, 08648, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Urological Surgeons of Long Island

Garden City, New York, 11530, United States

Location

Hudson Valley Urology

Kingston, New York, 12401, United States

Location

Hudson Valley Urology

Poughkeepsie, New York, 12601, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Associates, PC

Nashville, Tennessee, 37209, United States

Location

Department of Urology, Vienna University Medical School

Vienna, A-1090, Austria

Location

Urocentrum Praha

Prague, 120 00, Czechia

Location

Charles University, Clinic of Urology

Prague, Czechia

Location

Urology Department, Hviezdoslavova

Prague, Czechia

Location

Masaryk Hospital, Urology Dept.

Ústí nad Labem, 401 13, Czechia

Location

Department of Urology, Technical University of Dresden

Dresden, 01307, Germany

Location

Department of Urology, Semmelweis University

Budapest, H-1082, Hungary

Location

Department of Urology, Medical School, University of Pécs

Pécs, H-7621, Hungary

Location

Department of Urology, General Hospital of Bolzano

Bolzano, 39100, Italy

Location

Sexual Medicine Unit and Urology, Università Vita Salute San Raffaele Fondazione Centro San Raffaele del Monte Tabor

Milan, 20132, Italy

Location

Department of Urology, Jessenius Faculty of Medicine, Comenius University

Martin, Slovakia

Location

Institut Català d'Oncologia, Hospital Duran I Reynals, Servicio de Oncologia Medica

Barcelona, 08907, Spain

Location

Royal Free Hospital and School of Medicine

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

• Marberger M, Kaisary AV, Shore ND, Karlin GS, Savulsky C, Mis R, Leuratti C, Germa JR. Effectiveness, pharmacokinetics, and safety of a new sustained-release leuprolide acetate 3.75-mg depot formulation for testosterone suppression in patients with prostate cancer: a Phase III, open-label, international multicenter study. Clin Ther. 2010 Apr;32(4):744-57. doi: 10.1016/j.clinthera.2010.04.013.

  PMID: 20435244 DERIVED

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 Design

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

Study Record Dates

• First Submitted: August 8, 2005
• First Posted: August 10, 2005
• Study Start: September 1, 2005
• Study Completion: November 1, 2007
• Last Updated: November 14, 2007

Record last verified: 2007-11

Locations

SL (1); IT (2); US (15); DE (1); AU (1); ES (1); GB (1); HU (2); CZ (4)