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A Chemoprevention Study of an Investigational Drug in Men with High Grade Prostate Intraepithelial Neoplasia (PIN) Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Chemoprevention Study of an Investigational Drug in Men with High Grade Prostate Intraepithelial Neoplasia (PIN) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Chemoprevention Study of an Investigational Drug in Men with High Grade Prostate Intraepithelial Neoplasia (PIN) Clinical research trials and A Chemoprevention Study of an Investigational Drug in Men with High Grade Prostate Intraepithelial Neoplasia (PIN) medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Chemoprevention Study of an Investigational Drug in Men with High Grade Prostate Intraepithelial Neoplasia (PIN). A Chemoprevention Study of an Investigational Drug in Men with High Grade Prostate Intraepithelial Neoplasia (PIN) Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Chemoprevention Study of an Investigational Drug in Men with High Grade Prostate Intraepithelial Neoplasia (PIN) clinical trial. Subjects typically recieve the finest healthcare available for their A Chemoprevention Study of an Investigational Drug in Men with High Grade Prostate Intraepithelial Neoplasia (PIN) condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.

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A Chemoprevention Study of an Investigational Drug in Men with High Grade Prostate Intraepithelial Neoplasia (PIN)



A Chemoprevention Study of an Investigational Drug in Men with High Grade Prostate Intraepithelial Neoplasia (PIN)

For Condition: Prostatic Intraepithelial Neoplasia
Status: Recruiting
Sponsor(s): GTx , Health Decisions
Synopsis: If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate biopsy, you may be eligible for this study. This is a study of an investigational medication that may reduce high grade PIN and prevent the occurrence of prostate cancer. This study is currently enrolling up to 500 men at approximately 60 locations in the United States.
Details: High grade PIN is the development of precancerous, abnormal tissue of the prostate gland that puts men at high risk of developing prostate cancer. This study will take one year of participation with clinic visits every three months. There will be two prostate biopsies during the study, at six and twelve months. If qualified to participate, you will be randomly assigned to one of four treatment groups. Three out of four groups are varying doses of the study medication and the other is the placebo group (like a sugar pill).
Eligibility:
Study Type:
  Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 30 Years/
Genders: Male
Protocol Entry Criteria: - Must have confirmed high grade PIN on prostate biopsy within past 6 months. - Must have a serum PSA <12 ng/ml. - Can not have prostate cancer. - Have significant ocular opacities. - Can not take finasteride or other testosterone like supplement.
Total Enrollment: 500

Location and Contact Information:

University of Cincinnati Medical Center Division of Urology *Recruiting*
Cincinnati,  Ohio,  45267
United States
Recruiting Bruce  Bracken

Dr. Byron Hodge *Recruiting*
Orlando,  Florida,  32806
United States
Recruiting Byron  Hodge

H. Lee Moffitt Cancer Center
Tampa,  Florida,  33612-9497
United States
John  Seigne

Seattle Urological Associates *Recruiting*
Seattle,  Washington,  98104
United States
Recruiting James  Gottesman

Clinical Research of Westchester *Recruiting*
New Rochelle,  New York,  10801
United States
Recruiting John  Byrne

The Urology Center of Florida Inc.
Ocala,  Florida,  34474
United States
Ira  Klimberg

UroSearch *Recruiting*
Ocala,  Florida,  34474
United States
Recruiting David  Cunningham

Arkansas Urology Associates *Recruiting*
Little Rock,  Arkansas,  72211
United States
Recruiting Tim  Langford

Salem Research Group, Inc. *Recruiting*
Winston Salem,  North Carolina,  27103
United States
Recruiting Andrew  Griffin

Mid Atlantic Clinical Research *Recruiting*
Rockville,  Maryland,  20850
United States
Recruiting Mark  Ratner

Private Practice *Recruiting*
Huntsville,  Alabama,  35801
United States
Recruiting Amit  Chakrabarty

Urology Associates of Lancaster *Recruiting*
Lancaster,  Pennsylvania,  17604
United States
Recruiting Paul  Sieber

Wishard Memorial Hospital *Recruiting*
Indianapolis,  Indiana,  46202
United States
Recruiting Michael  Koch

Urology San Antonio Research *Recruiting*
San Antonio,  Texas,  78229
United States
Recruiting Clayton  Hudnall

Private Practice *Recruiting*
Staten Island,  New York,  10305
United States
Recruiting Ron  Israeli

South Florida Medical Research *Recruiting*
Aventura,  Florida,  33180
United States
Recruiting Marc  Gittelman

North Idaho Urology *Recruiting*
Coeur D Alene,  Idaho,  83814
United States
Recruiting William  Hall

Madigan Army Medical Center *Recruiting*
Tacoma,  Washington,  98431
United States
Recruiting Raymond  Costabile

Tri-State Urologic Services *Recruiting*
Cincinnati,  Ohio,  45212
United States
Recruiting William  Monnig

Urologic Surgery, P.C *Recruiting*
Bala Cynwyd,  Pennsylvania,  19004
United States
Recruiting Laurence  Belkoff

Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Erik  Goluboff

Sandy Springs Urology, P.C. *Recruiting*
Atlanta,  Georgia,  30328
United States
Recruiting Bruce  Green

Private Practice *Recruiting*
Las Vegas,  Nevada,  89109
United States
Recruiting Sheldon  Freedman

Medical & Clinical Research Associates *Recruiting*
Bay Shore,  New York,  11706
United States
Recruiting Daniel  Kim

UroSearch
Leesburg,  Florida,  34748
United States
Fouad  Shami

Newton Wellesley Urology *Recruiting*
Newton,  Massachusetts,  02162
United States
Recruiting Jeffery  Lamont


Additional Information:
Study ID Numbers:
  211; 
Study Start Date: April 2001
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028353

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