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Home > "C" Clinical Trials Conditions > Clinical Trial for Prostate Cancer  Clinical Trial for Prostate Cancer
Clinical Trial for Prostate Cancer
For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): Oakwood Laboratories, LLC ,
Synopsis: The purpose of this research study is to evaluate the safety and effectiveness of an investigational formulation of Leuprolide Acetate (leuprolide) for Injectable Suspension (slow release) manufactured for Oakwood Laboratories as a treatment for advanced prostate cancer. The active ingredient (leuprolide acetate) has been approved for the treatment, not the cure, of advanced prostate cancer. The slow-release formulation used in this study is considered investigational. An investigational formulation is one that has not been approved by the U.S. Food and Drug Administration (FDA).
Details: Approximately 48 subjects will be enrolled in the study. Subjects will be assigned to one of two study groups (approximately 24 subjects per group). Each group will receive a different lot of study drug. A minimum of 12 subjects from each group will be asked to participate in an additional leuprolide sub-study to evaluate the body’s absorption, distribution, metabolism, and excretion of leuprolide. If you meet the study entry requirements and agree to participate in this study, you will receive one intra-muscular injection of leuprolide every 84 days for a total of two injections. Your participation in this study will be approximately 24 weeks (six months).
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 40 Years/
Genders: Male
Protocol Entry Criteria: - Male at least 40-years-old - Pathology report documenting prostate cancer - Candidate for initial hormonal therapy - Meet inclusion criteria and do not meet any exclusion criteria (listed physicians have complete list of inclusion/exclusion criteria)
Total Enrollment: 48
Location and Contact Information:
Overall Study Official:
JamesPage, Study Chair, Oakwood Laboratories, LLC
Advanced Research Institute *Recruiting*
New Port Richey, Florida, 34652
United States
Recruiting Kristin White 727-835-3287
Salt Lake Research *Recruiting*
Salt Lake City, Utah, 84124
United States
Recruiting Jennifer Davis 801-288-9778
Lawrenceville Urology *Recruiting*
Lawrenceville, New Jersey, 08648
United States
Recruiting Research Staff 609-895-1991
Urological Surgeons of LI, PC *Recruiting*
Garden City, New York, 11530
United States
Recruiting Clinical Division 516-742-3200
Center for Urological Research *Recruiting*
La Mesa, California, 91942
United States
Recruiting Tami Goebel 619-460-0595
Hudson Valley Urology *Recruiting*
Poughkeepsie, New York, 12601
United States
Recruiting Jeanie Hefele 845-452-8730
San Diego Uro-Research *Recruiting*
San Diego, California, 92101
United States
Recruiting Pattie Sanchez-Emery 619-236-0045
South Florida Medical Research *Recruiting*
Aventura, Florida, 33180
United States
Recruiting Cheryl Ahlstrom 305-931-8080
South Orange County Medical Research Center *Recruiting*
Laguna Woods, California, 92653
United States
Recruiting Lori Davenport 949-215-9511
Urology San Antonio Research *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Patient Recruitment 210-477-8839
Additional Information:
Study ID Numbers: OL-007;
Study Start Date: January 2004
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076531
Other Prostate Cancer Studies:
1. Provenge® Immunotherapy Vaccine for the Treatment of Metastatic Prostate Cancer after Failing Hormone Therapy
2. Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer.
3. The Effect of Zometa on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
4. Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
5. Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
Related Studies:
Other Prostate Cancer Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
Clinical Trial for Prostate Cancer
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