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Clinical Trial for Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Clinical Trial for Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Clinical Trial for Prostate Cancer Clinical research trials and Clinical Trial for Prostate Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Clinical Trial for Prostate Cancer. Clinical Trial for Prostate Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Clinical Trial for Prostate Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Clinical Trial for Prostate Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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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. Gene Therapy in Treating Patients With Cancer
2. Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
3. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
4. Treatment Decision Intervention for Veterans with Prostate Cancer
5. Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer
Related Studies:
Other Prostate Cancer Clinical Trials
Other Florida Clinical Trials
Other Aventura Clinical Trials
Clinical Trial for Prostate Cancer
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