Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00128531
- Lead Sponsor
- GP-Pharm
- Brief Summary
The purpose of this study is to look at the efficacy and safety of leuprolide acetate in patients with prostate cancer.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 120
- 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
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Evidence of brain metastases, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms
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Evidence of spinal cord compression, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms
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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
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Excruciating, severe pain from extensive osseous deposits, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms
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Testosterone levels < 1.5 ng/mL at screening, locally determined at the laboratory of each clinical site
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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
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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]
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Previous treatment with androgen receptor (AR) blockers, such as Casodex®, Fugerel®, Megace®, Androcur® (no wash-out allowed)
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Previous orchiectomy, adrenalectomy or hypophysectomy
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Previous prostatic surgery (e.g. radical prostatectomy, transurethral resection of the prostate [TUR-P]) within 2 weeks of baseline
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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
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Any investigational drug within 5 half-lives of its physiological action or 3 months (whichever is longer) before baseline
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Administration of 5-alpha-reductase inhibitors (Proscar®, Avodart®, Propecia®) within 3 months before baseline
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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
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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
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Co-existent malignancy, according to the Investigator's opinion
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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
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Venous thrombosis within 6 months of baseline
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Insulin-dependent diabetes mellitus
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History of drug and/or alcohol abuse within 6 months of baseline
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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
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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.
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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)
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Known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or any excipients of the study formulation
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (27)
Florida Urology Specialists
🇺🇸Sarasota, Florida, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Department of Urology, Semmelweis University
🇭🇺Budapest, Hungary
Department of Urology, Medical School, University of Pécs
🇭🇺Pecs, Hungary
Charles University, Clinic of Urology
🇨🇿Praha, Czech Republic
Sexual Medicine Unit and Urology, Università Vita Salute San Raffaele Fondazione Centro San Raffaele del Monte Tabor
🇮🇹Milan, Italy
Department of Urology, Technical University of Dresden
🇩🇪Dresden, Germany
Urology Associates, PC
🇺🇸Nashville, Tennessee, United States
Department of Urology, Vienna University Medical School
🇦🇹Vienna, Austria
Urology Department, Hviezdoslavova
🇨🇿Prague, Czech Republic
Desert Oasis Cancer Center
🇺🇸Casa Granda, Arizona, United States
Hamilton Urology, P.A.
🇺🇸Hamilton, New Jersey, United States
Lakeside Urology
🇺🇸St. Joseph, Michigan, United States
Lawrenceville Urology
🇺🇸Lawrenceville, New Jersey, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Urological Surgeons of Long Island
🇺🇸Garden City, New York, United States
Department of Urology, General Hospital of Bolzano
🇮🇹Bolzano, Italy
Advanced Research Institute, Inc.
🇺🇸New Port Richey, Florida, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
Institut Català d'Oncologia, Hospital Duran I Reynals, Servicio de Oncologia Medica
🇪🇸Barcelona, Spain
Southwest Florida Urologic Associates
🇺🇸Fort Myers, Florida, United States
Hudson Valley Urology
🇺🇸Poughkeepsie, New York, United States
Royal Free Hospital and School of Medicine
🇬🇧London, United Kingdom
Urocentrum Praha
🇨🇿Prague, Czech Republic
Masaryk Hospital, Urology Dept.
🇨🇿Usti nad Labem, Czech Republic
Department of Urology, Jessenius Faculty of Medicine, Comenius University
🇸🇰Martin, Slovakia