Prostatic NeoplasmsNCT00056654
Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
A study testing Leuprolide acetate in people with Prostatic Neoplasms, run by Abbott at 55 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Leuprolide acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 55 sitesUnited States
- Study dates
- Mar 2003to Jul 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hypersensitivity to leuprolide acetate or polylactic acid
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- History of hypogonadism
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
United States55 sites
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508
Emory University
Atlanta, Georgia, 30322
Georgia Urology, PA
Atlanta, Georgia, 30342
Urology Research Options
Aurora, Colorado, 80012
South Florida Medical Research
Aventura, Florida, 33180
Suffolk Urology Associates
Bay Shore, New York, 11706
West Side Veteran Administration Medical Center
Chicago, Illinois, 60602
The Urology Group
Cincinnati, Ohio, 45212
Northeast Urology Research
Concord, North Carolina, 28025
Urology Specialists & Associates
Dallas, Texas, 75231
Urological Associates, PC
Davenport, Iowa, 52807
Atlantic Urological Associates
Daytona Beach, Florida, 32114
Urological Surgical Associates
Edison, New Jersey, 08837
Pacific Clinical Center
Encino, California, 91316
Los Angeles Clinical Research Center
Encino, California, 91416
Welborn Clinic East
Evansville, Indiana, 47713
Northeast Indiana Research
Fort Wayne, Indiana, 46825
Urology Associates of North Texas
Fort Worth, Texas, 76104
Urology Associates of Central California
Fresno, California, 93720
Urological Surgeons of Long Island
Garden City, New York, 11530
206 Research Associates
Greenbelt, Maryland, 20770
Urology Centers of Alabama
Homewood, Alabama, 35209
Medical Affiliated Research Center
Huntsville, Alabama, 35801
Urology of Indiana, LLC
Indianapolis, Indiana, 46202
UroSearch
Inverness, Florida, 34452
Kankakee Urological Associates
Kankakee, Illinois, 60901
Kansas City Urology Care
Kansas City, Missouri, 64111
Center for Urologic Research
La Mesa, California, 91942
South Orange County Medical Research Center
Laguna Woods, California, 92653
Sheldon J. Freedman, MD, LTD
Las Vegas, Nevada, 89109
Lawrenceville Urology
Lawrenceville, New Jersey, 08648
Arkansas Urology
Little Rock, Arkansas, 72211
Associated Urologic Specialists, PA
Marlton, New Jersey, 08053
Grand Strand Urology
Myrtle Beach, South Carolina, 29572
Vanderbilt Medical Center Dept of Urologic Surgery
Nashville, Tennessee, 37232
Advanced Research Institute
New Port Richey, Florida, 34652
Atlantic Urological Associates
New Smyrna Beach, Florida, 32168
UroSearch
Ocala, Florida, 34470
Florida Foundation for Healthcare Research
Ocala, Florida, 34474
Atlantic Urological Associates
Orange City, Florida, 32763
Specialty Care Research
Peoria, Illinois, 61614
Hudson Valley Urology
Poughkeepsie, New York, 12601
University Urological Research Institute
Providence, Rhode Island, 02906
Nevada Urology Associates
Reno, Nevada, 89511
Atlantic Urological Associates
Saint Augustine, Florida, 32086
Lawrenceville Urology
Saint Joseph, Michigan, 49085
Salt Lake Research
Salt Lake City, Utah, 84124
Urology San Antonio Research
San Antonio, Texas, 78229
San Diego Uro-Research
San Diego, California, 92101
Saint Louis Urological Surgeons, Inc
St Louis, Missouri, 63136
Madigan Army Medical Center
Tacoma, Washington, 98431
Western Clinical Research
Torrance, California, 90505
Devine-Tidewater Urology
Virginia Beach, Virginia, 23454
Connecticut Clinical Research Center
Waterbury, Connecticut, 06708
Center for Urologic Research of Western New York
Williamsville, New York, 14221
About this study
Official title: 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 will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.
Read the 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.
- Conditions
- Prostatic Neoplasms
- Being tested
- Leuprolide acetate
- Keywords
- Leuprolide, Prostatic Neoplasms, Testosterone, Prostate-specific Antigen, Pharmacokinetics, luprolide acetate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide acetateDrug
45 mg Intramuscular injection 6 month depot formulation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Leuprolide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.
Measured: Day 32 through Week 52
Secondary outcomes (4)
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
Measured: 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).
Measured: 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).
Measured: Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit
Change from baseline in prostatic acid phosphatase (PAP).
Measured: Weeks 1, 12, 26, 40, 52 and Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2003 (estimated)
- Study startMar 2003
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056654
- Sponsor's protocol ID
- C02-008
- Status last verified
- Sep 2008
- First submitted
- 20 Mar 2003
- Last updated
- 17 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma
- ClinicalTrials.gov ID
- NCT00056654
- Acronym / sponsor ID
- C02-008
- Conditions
- Prostatic Neoplasms
- Keywords
- Leuprolide, Prostatic Neoplasms, Testosterone, Prostate-specific Antigen, Pharmacokinetics, luprolide acetate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 21 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Leuprolide acetate |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Hypersensitivity to leuprolide acetate or polylactic acid
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- History of hypogonadism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leuprolide acetate45 mg Intramuscular injection 6 month depot formulation | Drug | 1 |
Primary outcome
Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.
Time frame: Day 32 through Week 52
4 secondary outcomes
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
Time frame: 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).
Time frame: 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).
Time frame: Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit
Change from baseline in prostatic acid phosphatase (PAP).
Time frame: Weeks 1, 12, 26, 40, 52 and Final Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leuprolide acetate in people with Prostatic Neoplasms, run by Abbott at 55 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects. (time frame: Day 32 through Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2008; AzTrials last refreshed its copy on 7 Nov 2026.