Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT00128531

Run by

GP-Pharm

People needed

120

Starts

2005-09-01

Expected to finish

2007-11-01

Last updated by the study team

2007-11-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• Urology Centers of Alabama — Homewood, Alabama, United States
• Desert Oasis Cancer Center — Casa Granda, Arizona, United States
• Southwest Florida Urologic Associates — Fort Myers, Florida, United States
• Advanced Research Institute, Inc. — New Port Richey, Florida, United States
• Florida Urology Specialists — Sarasota, Florida, United States
• Regional Urology — Shreveport, Louisiana, United States
• Lakeside Urology — Saint Joseph, Michigan, United States
• Hamilton Urology, P.A. — Hamilton, New Jersey, 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
• Hudson Valley Urology — Kingston, New York, United States
• Hudson Valley Urology — Poughkeepsie, New York, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology Associates, PC — Nashville, Tennessee, United States
• Department of Urology, Vienna University Medical School — Vienna, Austria
• Urocentrum Praha — Prague, Czechia
• Charles University, Clinic of Urology — Prague, Czechia
• Urology Department, Hviezdoslavova — Prague, Czechia
• Masaryk Hospital, Urology Dept. — Ústí nad Labem, Czechia
• Department of Urology, Technical University of Dresden — Dresden, Germany
• Department of Urology, Semmelweis University — Budapest, Hungary
• Department of Urology, Medical School, University of Pécs — Pécs, Hungary
• Department of Urology, General Hospital of Bolzano — Bolzano, Italy
• Sexual Medicine Unit and Urology, Università Vita Salute San Raffaele Fondazione Centro San Raffaele del Monte Tabor — Milan, Italy

Full record on ClinicalTrials.gov

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