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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


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.


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 ULN (upper limit of normal) for the clinical laboratory

- Adequate and stable hepatic function as defined by bilirubin and transaminases (i.e. SGOT, SGPT) 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Authority:

United States: Food and Drug Administration

Study ID:

CRO-04-62

NCT ID:

NCT00128531

Start Date:

September 2005

Completion Date:

November 2007

Related Keywords:

  • Prostate Cancer
  • Phase III
  • open label
  • multiple dose
  • safety study
  • pharmacokinetic study
  • efficacy study
  • Prostatic Neoplasms

Name

Location

AccuMed Research AssociatesGarden City, New York  11530
Urology Centers Of AlabamaHomewood,, Alabama  35205
Regional UrologyShreveport, Louisiana  71106
Lawrenceville UrologyLawrenceville, New Jersey  08648
Urological Surgeons of Long IslandGarden City, New York  11530
Hudson Valley UrologyPoughkeepsie, New York  12601
Advanced Research Institute, Inc.New Port Richey, Florida  34652
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Desert Oasis Cancer CenterCasa Grande, Arizona  85222
Southwest Florida Urologic AssociatesFort Myers, Florida  33907
Lakeside UrologySt. Joseph, Michigan  49085
Florida Urology SpecialistsSarasota, Florida  34237
Hamilton Urology, P.A.Hamilton, New Jersey  08690
Urology Associates, PCNashville, Tennessee  37209