Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer

November 12, 2007 updated by: GP-Pharm

Efficacy and Safety of a New Leuprolide Acetate 3.75 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Other assessments include evaluation of main leuprolide PK parameters in 12 subjects after administration of 3 doses.

Study Design:

This will be a multi-center, open-label, fixed investigation of six monthly dosages of leuprolide acetate 3.75 mg administered to patients with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy.

A total of 120 male patients will receive a single, i.m. injection of leuprolide acetate 3.75 mg initially on study day 0 (after baseline assessment) and then monthly (i.e. every 28 days) for five months.

12 of the patients will also have plasma leuprolide levels measured for PK analysis during the first 3 injection periods (PK group). These patients will belong to pre-defined study sites.

Study Type

Interventional

Enrollment

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Department of Urology, Vienna University Medical School
  • Czech Republic
      • Prague, Czech Republic, 120 00
        • Urocentrum Praha
      • Prague, Czech Republic
        • Urology Department, Hviezdoslavova
      • Praha, Czech Republic
        • Charles University, Clinic of Urology
      • Usti nad Labem, Czech Republic, 401 13
        • Masaryk Hospital, Urology Dept.
  • Germany
      • Dresden, Germany, 01307
        • Department of Urology, Technical University of Dresden
  • Hungary
      • Budapest, Hungary, H-1082
        • Department of Urology, Semmelweis University
      • Pecs, Hungary, H-7621
        • Department of Urology, Medical School, University of Pécs
  • Italy
      • Bolzano, Italy, 39100
        • Department of Urology, General Hospital of Bolzano
      • Milan, Italy, 20132
        • Sexual Medicine Unit and Urology, Università Vita Salute San Raffaele Fondazione Centro San Raffaele del Monte Tabor
  • Slovakia
      • Martin, Slovakia
        • Department of Urology, Jessenius Faculty of Medicine, Comenius University
  • Spain
      • Barcelona, Spain, 08907
        • Institut Català d'Oncologia, Hospital Duran I Reynals, Servicio de Oncologia Medica
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital and School of Medicine
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers Of Alabama
    • Arizona
      • Casa Granda, Arizona, United States, 85222
        • Desert Oasis Cancer Center
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Southwest Florida Urologic Associates
      • New Port Richey, Florida, United States, 34652
        • Advanced Research Institute, Inc.
      • Sarasota, Florida, United States, 34237
        • Florida Urology Specialists
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology
    • Michigan
      • St. Joseph, Michigan, United States, 49085
        • Lakeside Urology
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Hamilton Urology, P.A.
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrenceville Urology
    • New York
      • Garden City, New York, United States, 11530
        • AccuMed Research Associates
      • Garden City, New York, United States, 11530
        • Urological Surgeons of Long Island
      • Kingston, New York, United States, 12401
        • Hudson Valley Urology
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Urology
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Urology Associates, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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
  • Signed written informed consent prior to inclusion in the study

Exclusion Criteria:

  • 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
  • Co-existent malignancy, according to the Investigator's opinion
  • Uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft) or significant symptomatic cardiovascular disease(s) within 6 months before baseline; resting uncontrolled hypertension: (>/= 160/100 mmHg) or symptomatic hypotension within 3 months before baseline
  • Venous thrombosis within 6 months of baseline
  • Insulin-dependent diabetes mellitus
  • History of drug and/or alcohol abuse within 6 months of baseline
  • Serious concomitant illness(es) or disease(s) [e.g., hematological, renal, hepatic, respiratory, endocrine, psychiatric] that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol
  • Patients receiving anticoagulants who have prothrombin and partial thromboplastin times outside of the normal range for the laboratory assays; patients who are on anticoagulation or antiplatelet medications (e.g. dipyridamole, ticlopidine, warfarin derivatives) who are not receiving a stable dose for 3 months before baseline; patients who are receiving warfarin-derivative anticoagulants who do not have an International Normalized Ratio (INR) in the therapeutic range for the clinical indication for which the anticoagulant has been prescribed.
  • Blood donations/losses within 2 months of baseline, apart from previous prostatic surgery patients (see earlier exclusion [9]; please note that these patients should not be included in the pharmacokinetic [PK] group)
  • Known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or any excipients of the study formulation

  • History of the following prior to the study:

    • immunization (within 4 weeks of baseline);
    • flu shots (within 2 weeks of baseline);
    • anaphylaxis;
    • skin disease which would interfere with injection site evaluation;
    • dermatographism will be documented at screening and followed up while on treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GP-Pharm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (Estimate)

August 10, 2005

Study Record Updates

Last Update Posted (Estimate)

November 14, 2007

Last Update Submitted That Met QC Criteria

November 12, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-04-62

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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