Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00056654

Collaborator

(none)

164

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: Leuprolide acetate	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

164 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Jul 1, 2004

Actual Study Completion Date :

Jul 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Leuprolide acetate 45 mg Intramuscular injection 6 month depot formulation

Arm

Intervention/Treatment

Experimental: 1

Drug: Leuprolide acetate

45 mg Intramuscular injection 6 month depot formulation

Outcome Measures

Primary Outcome Measures

Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects. [Day 32 through Week 52]

Secondary Outcome Measures

Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status. [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Final Visit]
Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty). [Weeks 1, 4, 8, 12, 16, 20, 24, 26, 27, 28, 30, 32, 36, 40, 44, 48, 52 and Final Visit]
Change from baseline in prostate specific antigen (PSA). [Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit]
Change from baseline in prostatic acid phosphatase (PAP). [Weeks 1, 12, 26, 40, 52 and Final Visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology Centers of Alabama	Homewood	Alabama	United States	35209
2	Medical Affiliated Research Center	Huntsville	Alabama	United States	35801
3	Alaska Clinical Research Center, LLC	Anchorage	Alaska	United States	99508
4	Arkansas Urology	Little Rock	Arkansas	United States	72211
5	Pacific Clinical Center	Encino	California	United States	91316
6	Los Angeles Clinical Research Center	Encino	California	United States	91416
7	Urology Associates of Central California	Fresno	California	United States	93720
8	Center for Urologic Research	La Mesa	California	United States	91942
9	South Orange County Medical Research Center	Laguna Woods	California	United States	92653
10	San Diego Uro-Research	San Diego	California	United States	92101
11	Western Clinical Research	Torrance	California	United States	90505
12	Urology Research Options	Aurora	Colorado	United States	80012
13	Connecticut Clinical Research Center	Waterbury	Connecticut	United States	06708
14	South Florida Medical Research	Aventura	Florida	United States	33180
15	Atlantic Urological Associates	Daytona Beach	Florida	United States	32114
16	UroSearch	Inverness	Florida	United States	34452
17	Advanced Research Institute	New Port Richey	Florida	United States	34652
18	Atlantic Urological Associates	New Smyrna Beach	Florida	United States	32168
19	UroSearch	Ocala	Florida	United States	34470
20	Florida Foundation for Healthcare Research	Ocala	Florida	United States	34474
21	Atlantic Urological Associates	Orange City	Florida	United States	32763
22	Atlantic Urological Associates	St. Augustine	Florida	United States	32086
23	Emory University	Atlanta	Georgia	United States	30322
24	Georgia Urology, PA	Atlanta	Georgia	United States	30342
25	West Side Veteran Administration Medical Center	Chicago	Illinois	United States	60602
26	Kankakee Urological Associates	Kankakee	Illinois	United States	60901
27	Specialty Care Research	Peoria	Illinois	United States	61614
28	Welborn Clinic East	Evansville	Indiana	United States	47713
29	Northeast Indiana Research	Fort Wayne	Indiana	United States	46825
30	Urology of Indiana, LLC	Indianapolis	Indiana	United States	46202
31	Urological Associates, PC	Davenport	Iowa	United States	52807
32	206 Research Associates	Greenbelt	Maryland	United States	20770
33	Lawrenceville Urology	St Joseph	Michigan	United States	49085
34	Kansas City Urology Care	Kansas City	Missouri	United States	64111
35	Saint Louis Urological Surgeons, Inc	St Louis	Missouri	United States	63136
36	Sheldon J. Freedman, MD, LTD	Las Vegas	Nevada	United States	89109
37	Nevada Urology Associates	Reno	Nevada	United States	89511
38	Urological Surgical Associates	Edison	New Jersey	United States	08837
39	Lawrenceville Urology	Lawrenceville	New Jersey	United States	08648
40	Associated Urologic Specialists, PA	Marlton	New Jersey	United States	08053
41	Suffolk Urology Associates	Bay Shore	New York	United States	11706
42	Urological Surgeons of Long Island	Garden City	New York	United States	11530
43	Hudson Valley Urology	Poughkeepsie	New York	United States	12601
44	Center for Urologic Research of Western New York	Williamsville	New York	United States	14221
45	Northeast Urology Research	Concord	North Carolina	United States	28025
46	The Urology Group	Cincinnati	Ohio	United States	45212
47	University Urological Research Institute	Providence	Rhode Island	United States	02906
48	Grand Strand Urology	Myrtle Beach	South Carolina	United States	29572
49	Vanderbilt Medical Center Dept of Urologic Surgery	Nashville	Tennessee	United States	37232
50	Urology Specialists & Associates	Dallas	Texas	United States	75231
51	Urology Associates of North Texas	Fort Worth	Texas	United States	76104
52	Urology San Antonio Research	San Antonio	Texas	United States	78229
53	Salt Lake Research	Salt Lake City	Utah	United States	84124
54	Devine-Tidewater Urology	Virginia Beach	Virginia	United States	23454
55	Madigan Army Medical Center	Tacoma	Washington	United States	98431