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Efficacy and Safety of a New Leuprolide Acetate 17 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 17 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients


Inclusion Criteria:



- Males 18 years of age, with histologically proven carcinoma of prostate, who might
benefit from medical androgen deprivation therapy;

- life expectancy of at least 1 year;

- WHO/ECOG performance status of 0, 1, or 2;

- adequate renal function at screening as defined by serum creatinine <= 1.6 times the
upper limit of normal (ULN) 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;

- presence of any tumor in the immediate vicinity which could cause cord compression,
in the opinion of the Investigator, taking into account medical history and clinical
observations;

- 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 LHRH analogues
(e.g. Lupron®, Zoladex®, etc.) (no wash-out allowed);

- previous treatment with AR-receptor 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 prior to or after baseline;

- previous local therapy to the primary tumor with a curative attempt other than
surgery (external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy)
within 2 weeks prior to or after baseline;

- any investigational drug within 5 half-lives of its physiological action or 3 months,
whichever is longer, before baseline;

- administration of 5-α-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®, 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;

- uncontrolled diabetes (patients with uncontrolled diabetes need to compensate the
metabolic disorder before treatment with LH-RH analogues);

- 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 on anticoagulative therapy including warfarin (Coumadin®) and heparin. Those
patients on low dose low molecular weight heparin may be enrolled in the study;

- Abnormal coagulation studies (PT/PTT) at baseline.

- blood donations/losses within 2 months of baseline, apart from previous prostatic
surgery patients (see exclusion 10);

- 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 1 week of baseline or 1 week prior to and after study drug
administration);

- 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: Supportive Care

Outcome Measure:

Percent of successful patients achieving chemical castration

Outcome Time Frame:

Days 28, 84, and 168

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

GP/C/04/PRO

NCT ID:

NCT00630799

Start Date:

May 2008

Completion Date:

July 2009

Related Keywords:

  • Prostate Cancer
  • prostate
  • cancer
  • Prostatic Neoplasms

Name

Location

Advanced Research InstituteNew Port Richey, Florida  34652
Center for Urologic CareWest Reading, Pennsylvania  19611
Urology AssociatesNashville, Tennessee  37209
Lawrenceville UrologyLawrenceville, New Jersey  08648
Hudson Valley UrologyPoughkeepsie, New York  12601
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Urology San Antonio Research, PASan Antonio, Texas  78229
Piedmont Medical ResearchWinston-Salem, North Carolina  27103