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Efficacy and Safety Study of a New Leuprolide Acetate 17 mg Depot to Treat Prostate Cancer Patients

Information source: GP-Pharm
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: leuprolide acetate (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: GP-Pharm

Summary

This is a multi-center, open-label study of 2 doses of leuprolide acetate 17 mg depot, administered three months apart, in subjects with prostate cancer who might benefit from medical androgen deprivation therapy

Clinical Details

Official title: 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

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

Primary outcome: Percent of successful patients achieving chemical castration

Secondary outcome:

WHO/ECOG performance status

Serum LH concentration (mIU/mL)

Serum FSH concentration (mIU/mL)

Serum PSA concentration (ng/mL)

Frequency of bone pain

plasma testosterone concentration (ng/mL) in PK population

Occurrence of hot flushes

Plasma leuprolide concentrations (pg/mL) in PK population

Frequency of urinary symptoms

Frequency of urinary pain

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Advanced Research Institute, New Port Richey, Florida 34655, United States

Lawrenceville Urology, Lawrenceville, New Jersey 08648, United States

Hudson Valley Urology, Poughkeepsie, New York 12601, United States

Piedmont Medical Research, Winston-Salem, North Carolina 27103, United States

Center for Urologic Care, Bryn Mawr, Pennsylvania 19010, United States

Carolina Urologic Research Center, Myrtle Beach, South Carolina 29572, United States

Urology Associates, Nashville, Tennessee 37209, United States

Urology San Antonio Research, PA, San Antonio, Texas 78229, United States

Additional Information

Starting date: May 2008
Last updated: September 7, 2010

Page last updated: August 23, 2015

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