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Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma


N/A
N/A
N/A
Not Enrolling
Male
Prostatic Neoplasms

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Trial Information

Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma


The primary purpose of the study is to determine if a new sustained-release 45 mg (depot)
formulation of leuprolide acetate administered once every 26 weeks for 1 year, will lower
testosterone levels to and maintain them at medically castrate levels in subjects with
prostatic adenocarcinoma. This study will also evaluate the pharmacokinetic profile of the
45 mg formulation and assess the safety of this formulation.


Inclusion Criteria:



- Histological diagnosis of prostate cancer

- Need for androgen deprivation treatment for 1 year

- Serum testosterone level ≥ 150 ng/dL

- Life expectancy of at least 18 months

- ECOG Performance status grades 0,1 or 2

Exclusion Criteria:

- Hypersensitivity to leuprolide acetate or polylactic acid

- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy

- History of hypogonadism

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:

Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.

Outcome Time Frame:

Day 32 through Week 52

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

C02-008

NCT ID:

NCT00056654

Start Date:

March 2003

Completion Date:

July 2004

Related Keywords:

  • Prostatic Neoplasms
  • Leuprolide
  • Prostatic Neoplasms
  • Testosterone
  • Prostate-specific Antigen
  • Pharmacokinetics
  • luprolide acetate
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Madigan Army Medical CenterTacoma, Washington  98431-5048
206 Research AssociatesGreenbelt, Maryland  20770
Urology San Antonio ResearchSan Antonio, Texas  78229
Atlantic Urological AssociatesDaytona Beach, Florida  32114
Urology Associates of North TexasArlington, Texas  76015
Medical Affiliated Research CenterHuntsville, Alabama  35801
Emory UniversityAtlanta, Georgia  30322
South Florida Medical ResearchAventura, Florida  33180
UroSearchLeesburg, Florida  34748
Urology Research OptionsAurora, Colorado  80012
Connecticut Clinical Research CenterWaterbury, Connecticut  06708-2652
Advanced Research InstituteNew Port Richey, Florida  34652
Northeast Indiana ResearchFort Wayne, Indiana  46804-4128
Urology of Indiana, LLCIndianapolis, Indiana  46202
Alaska Clinical Research Center, LLCAnchorage, Alaska  99508
Florida Foundation for Healthcare ResearchOcala, Florida  34474
Kansas City Urology CareKansas City, Missouri  64131
Urological Surgical AssociatesEdison, New Jersey  
The Urology GroupCincinnati, Ohio  45212
Grand Strand UrologyMyrtle Beach, South Carolina  29572
Urology Centers Of AlabamaHomewood,, Alabama  35205
South Orange County Medical Research CenterLaguna Hills, California  92653
Nevada Urology AssociatesReno, Nevada  89511
Salt Lake ResearchSalt Lake City, Utah  84124
Urology Associates Of Central CaliforniaFresno, California  93720
Lawrenceville UrologyLawrenceville, New Jersey  08648
University Urological Research InstituteProvidence, Rhode Island  02904
San Diego Uro-ResearchSan Diego, California  92101
Arkansas UrologyLittle Rock, Arkansas  72211
Pacific Clinical CenterEncino, California  91316
Los Angeles Clinical Research CenterEncino, California  91416
Center for Urologic ResearchLa Mesa, California  91942
Western Clinical ResearchTorrance, California  90505
Georgia Urology, PAAtlanta, Georgia  30342
West Side Veteran Administration Medical CenterChicago, Illinois  60602
Kankakee Urological AssociatesKankakee, Illinois  60901
Specialty Care ResearchPeoria, Illinois  61614
Welborn Clinic EastEvansville, Indiana  47713
Urological Associates, PCDavenport, Iowa  52807
Lawrenceville UrologySt Joseph, Michigan  49085
Saint Louis Urological Surgeons, IncSt Louis, Missouri  63136
Sheldon J. Freedman, MD, LTDLas Vegas, Nevada  89109
Associated Urologic Specialists, PAMarlton, New Jersey  08053
Suffolk Urology AssociatesBay Shore, New York  11706
Urological Surgeons of Long IslandGarden City, New York  11530
Hudson Valley UrologyPoughkeepsie, New York  12601
Center for Urologic Research of Western New YorkWilliamsville, New York  14221
Northeast Urology ResearchConcord, North Carolina  28025
Vanderbilt Medical Center Dept of Urologic SurgeryNashville, Tennessee  37232
Urology Specialists & AssociatesDallas, Texas  75231
Devine-Tidewater UrologyVirginia Beach, Virginia  23454