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

NCT00630799 | Terminated Phase 3

• 1 other identifier: GP/C/04/PRO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Prostate Cancer

Keywords

prostate; cancer

Outcome Measures

Primary Outcomes (1)

• Percent of successful patients achieving chemical castration

  Days 28, 84, and 168

Secondary Outcomes (10)

• WHO/ECOG performance status

  Days 14, 28, 56, 84, 112, and 168

• Serum LH concentration (mIU/mL)

  Days 2, 14, 28, 56, 84, 86, 112, and 168

• Serum FSH concentration (mIU/mL)

  Days 2, 14, 28, 56, 84, 86, 112, and 168

• Serum PSA concentration (ng/mL)

  Days 2, 14, 28, 56, 84, 86, 112, and 168

• Frequency of bone pain

  Days 2, 14, 28, 56, 54, 84, 86, 112, and 168

Study Arms (1)

1

EXPERIMENTAL

leuprolide acetate administered by i.m. injection as two doses of 17 mg each during a period of 6 months (one dose every 3 months)

Drug: leuprolide acetate

Interventions

leuprolide acetate DRUG

17 mg i.m.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

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;
• 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;

Sponsors & Collaborators

• GP-Pharm: lead

Study Sites (8)

Advanced Research Institute

New Port Richey, Florida, 34655, United States

Location

Lawrenceville Urology

Lawrenceville, New Jersey, 08648, United States

Location

Hudson Valley Urology

Poughkeepsie, New York, 12601, United States

Location

Piedmont Medical Research

Winston-Salem, North Carolina, 27103, United States

Location

Center for Urologic Care

Bryn Mawr, Pennsylvania, 19010, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Associates

Nashville, Tennessee, 37209, United States

Location

Urology San Antonio Research, PA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 7, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 9, 2010

Record last verified: 2010-09

Locations

US (8)