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Clinical Trial: Safety & Efficacy of Toremifene Citrate for Prevention of Bone Fractures in Men with Prostate Cancer on Androgen Deprivation Therapy
This study is currently recruiting patients.
Verified by GTx August 2005
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Purpose
Androgen Deprivation Therapy Treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The purpose of the study is to determine whether or not the addition of toremifene citrate (the study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy.
| Condition | Intervention | Phase |
|---|---|---|
| Prostate Cancer Osteoporosis Bone Loss Fractures | Drug: Toremifene Citrate | Phase III |
MedlinePlus related topics: Fractures; Osteoporosis; Prostate Cancer
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
Further Study Details:
Primary Outcomes: Percentage of subjects at 24 months with at least one new vertebral fracture determined by blinded central review of radiographs of the thoracic and lumbar spine
Secondary Outcomes: Percentage of subjects with at least one new or worsening vertebral fracture at 24 months; Percentage of subjects with a clinical fragility fracture at 12 and 24 months; Percent change from baseline in lumbar BMD as measured by DEXA scan at 24 months
Expected Total Enrollment: 1200
Secondary Outcomes: Percentage of subjects with at least one new or worsening vertebral fracture at 24 months; Percentage of subjects with a clinical fragility fracture at 12 and 24 months; Percent change from baseline in lumbar BMD as measured by DEXA scan at 24 months
Expected Total Enrollment: 1200
Study start: October 2003
Last follow-up: September 2007; Data entry closure: January 2008
Eligibility
Ages Eligible for Study: 50 Years and above, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
- To be eligible for participation in this study, subjects must meet all of the following criteria (minor deviations may be discussed with the medical monitor for possible inclusions):
• Give voluntary, signed informed consent in accordance with institutional policies • Be male, aged ≥ 50 years • Have histologically documented prostate cancer. Subjects with metastatic prostate cancer may still be considered for the study as long as they are not disqualified by other inclusion/exclusion criteria and there is a reasonable expectation that their medical condition will not interfere with the objectives of the study and that adequate follow-up and compliance with the study protocol can be achieved for the full 24-month duration of the study.
• Have been on a) ADT treatment (either LHRHa or orchiectomy) for at least 6 months. Or b) Intermittent LHRHa for at least the preceding 12 months is acceptable, but subjects must be maintained on uninterrupted treatment for the duration of this study once they are randomized into the study.
• a) Be aged ≥ 70 years or b) have BMD of lumbar spine or femoral neck at or below the specified thresholds for study entry
BMD Threshold Hologic BMD (g/cm2) Lunar BMD (g/cm2) L1-L4 0.926 1.050 Femoral Neck 0.717 0.840
• Serum PSA ≤ 4 ng/mL • Have a Zubrod performance status ≤ 1 (See Appendix B) • Subject weight < 300 lbs (weight limitation of DEXA equipment) • Agree to complete a daily diary of medication intake and to provide tablet containers for accurate counts • Agree to use an effective method of contraception, if the partner is of childbearing age, while on study • Have adequate bone marrow, liver and renal function: White Blood Cell (WBC) Count ≥ 3,000/mm3 Platelet Count ≥ 100,000/mm3 Bilirubin ≤ 1.5 mg/dL AST and ALT < 2x upper limit of normal Serum Creatinine ≤ 2.0 mg%
Exclusion Criteria:
- Subjects with any of the following will not be eligible for enrollment:
• Taking bisphosphonates, SERMs, PTH, Forteo® (teriparatide), calcitonin, or oral glucocorticoids within 45 days of randomization • Have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic and lumbar spine (at least eight evaluable vertebrae in the range T4 to L4) (for example, severe scoliosis, or sequelae of orthopedic procedures or other surgery) • Have > 4 vertebral fragility fractures • Have any history of other carcinomas within the last 5 years (except nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of recurrence which will not be excluded).
NOTE: Patients with cancers other than nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of tumor recurrence for at least 5 years after definitive treatment will not be excluded from this study.
• Have Paget’s disease of bone • Have active systemic viral, bacterial or fungal infections requiring treatment • Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol for the full 24-month duration of the study • Received treatment with other investigational agents within 30 days prior to randomization • Taking finasteride (e.g., Proscar®), dutasteride (e.g., Avodart®), Danocrine® (danazol) or testosterone-like supplements, such as dehydroepiandrosterone (DHEA) (subject is eligible if he stops these agents for a total washout of 45 days prior to randomization and agrees not to use these agents for the duration of the study) • Taking herbal medicine or dietary supplements for prostate health, such as PC SPES and Saw Palmetto (also known as Seronea Pepens) (subject is eligible if he stops these agents for a total washout of 45 days prior to randomization and agrees not to use these agents for the duration of the study). Lycopene and selenium are not prohibited and no washout is required.
• Have a history of thromboembolic disease including deep vein thrombosis or pulmonary embolus • Have a history of chronic hepatitis or cirrhosis • Have received prior treatment with toremifene
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00129142
Joye O''''Rourke, BSN 901-523-9700 Ext. 117 jorourke@gtxinc.com
Leslie D Gooch, BS/CCRP 901-523-9700 Ext. 193 lgoochharris@gtxinc.com
Leslie D Gooch, BS/CCRP 901-523-9700 Ext. 193 lgoochharris@gtxinc.com
Alabama
Urology Centers of Alabama, Homewood, Alabama, 35209, United States; Recruiting
Cynthia Nasiogik 205-445-0125 cnasiogik@uca.medclinic.net
Walter Pittman, MD, Principal Investigator
Walter Pittman, MD, Principal Investigator
Coastal Clinical Research, Mobile, Alabama, 36608, United States; Recruiting
Julie Clark 251-414-1984 juliec@coastalclinicalresearch.com
Charles White, MD, Principal Investigator
Charles White, MD, Principal Investigator
Arkansas
Arkansas Urology, Little Rock, Arkansas, 72211, United States; Recruiting
Anne Tursky 501-219-8900 anne@arkansasurology.com
J. Walt Stallings, MD, Principal Investigator
J. Walt Stallings, MD, Principal Investigator
California
Center of Urologic Research, La Mesa, California, 91942, United States; Recruiting
Tami Goebel 619-460-0595 tami@cursd.com
Mohamed Bidair, MD, Principal Investigator
Mohamed Bidair, MD, Principal Investigator
Pacific Clinical Research, Santa Monica, California, 90404, United States; Recruiting
Bertha Navarrete 310-829-1317 bnavarrete@pcrsm.com
Stanley Brosman, MD, Principal Investigator
Stanley Brosman, MD, Principal Investigator
San Bernadino Urological Associates, San Bernadino, California, 92404, United States; Recruiting
Teresa Pedraza 909-882-3813 teresa@sburology.com
Franklin Chu, Principal Investigator
Franklin Chu, Principal Investigator
Veterans Medical Research Foundation, San Diego, California, 92161, United States; Recruiting
Jane Jenkins 619-543-5579 j2jenkins@ucsd.edu
Tracy Downs, MD, Principal Investigator
Tracy Downs, MD, Principal Investigator
West Coast Clinical Research, Tarzana, California, 91356, United States; Recruiting
Teri Mata 818-901-8546 Ext. 118 tmata@wccresearch.com
Eugene Dula, MD, Principal Investigator
Eugene Dula, MD, Principal Investigator
Urological Physicians of San Diego, San Diego, California, 92103, United States; Recruiting
Karen Goodrum 619-299-0670 kgoodrum@aol.com
Danny Keiller, MD, Principal Investigator
Danny Keiller, MD, Principal Investigator
Urological Sciences Research Foudation, Culver City, California, 90232, United States; Recruiting
Malu Macairan 310-838-6347 mmacairan
Leonard Marks, MD, Principal Investigator
Leonard Marks, MD, Principal Investigator
Palo Alto VA, Palo Alto, California, 94305, United States; Recruiting
Karen Bratcher 650-493-5000 Ext. 64572 karen.bratcher@med.va.gov
Stewart McCallum, MD, Principal Investigator
Stewart McCallum, MD, Principal Investigator
Urological Associates of Central CA, Fresno, California, 93720, United States; Recruiting
Rebekah Rau 559-321-2878 rrau@urologyassociates.net
William Schiff, MD, Principal Investigator
William Schiff, MD, Principal Investigator
Advanced Urology Medical Center Clinical Trials, Anaheim, California, 92801, United States; Recruiting
Vera Martinez 714-776-2030 advancedutotrial@aol.com
Alfred Sidhom, MD, Principal Investigator
Alfred Sidhom, MD, Principal Investigator
South Orange County Medical Research Center, Laguna Woods, California, 92653, United States; Recruiting
Kristy Putman 949-215-9515 Ext. 236 kputman@urologymedical.com
Jay Young, MD, Principal Investigator
Jay Young, MD, Principal Investigator
Western Clinical Research, Inc., Torrance, California, 90505, United States; Recruiting
Carolyn Ferguson 310-791-5634 Ext. 187 fergie@latrials.com
Norman Zinner, MD, Principal Investigator
Norman Zinner, MD, Principal Investigator
Colorado
Urology Associates, Denver, Colorado, 80210, United States; Recruiting
Tanya Frazier 303-733-8873 Ext. 1267 tfrazier@uradenver.com
Barrett Cowan, MD, Principal Investigator
Barrett Cowan, MD, Principal Investigator
Western Urological Research, Wheat Ridge, Colorado, 80033, United States; Recruiting
Kevin Hare 303-421-5783 research@westernurologic.com
Lawrence Karsh, MD, Principal Investigator
Lawrence Karsh, MD, Principal Investigator
Connecticut
Connecticut Clinical Research, Waterbury, Connecticut, 06708, United States; Recruiting
Nancy Scacco 203-754-3588 Ext. 358 ccrcuro@aol.com
Robert Feldman, MD, Principal Investigator
Robert Feldman, MD, Principal Investigator
Urologic Center, New Haven, Connecticut, 06511, United States; Recruiting
Joanne Wilhelmy 203-789-2222 office@urologycenter.com
Stanton Honig, MD, Principal Investigator
Stanton Honig, MD, Principal Investigator
Urological Associates of Bridgeport, Trumball, Connecticut, 06611, United States; Recruiting
Katharine Nunnink 203-375-3456 cknunn@bpthosp.org
Arthur Pinto, MD, Principal Investigator
Arthur Pinto, MD, Principal Investigator
District of Columbia
Walter Reed Army Medical Center, Washington, District of Columbia, 20307, United States; Recruiting
Stephanie Shaar 202-782-4207 stephanie.shaar@na.amedd.army.mil
David McLeod, MD, Principal Investigator
David McLeod, MD, Principal Investigator
Florida
UroSearch, Tavares, Florida, 32778, United States; Recruiting
352-732-6040 urosearch@atlantic.net
Charles Cartwright, MD, Principal Investigator
Charles Cartwright, MD, Principal Investigator
Central Florida Urology Group/ UroSearch, Ocala, Florida, 34474, United States; Recruiting
352-732-6040 urosearch@atlantic.net
David Cunningham, MD, Principal Investigator
David Cunningham, MD, Principal Investigator
Atlantic Urological Associates, Daytona Beach, Florida, 32114, United States; Recruiting
Jonelle Horsley 386-239-8585 jhorsley@atlanticurology.com
Martin Dineen, MD, Principal Investigator
Martin Dineen, MD, Principal Investigator
Tampa Bay Urology, Tampa, Florida, 33607, United States; Recruiting
Linda Haynie 813-872-7881 LA@ISRnet.com
Todd Fusia, MD, Principal Investigator
Todd Fusia, MD, Principal Investigator
South Florida Medical Research, Aventura, Florida, 33180, United States; Recruiting
Sayonara Nunez 305-931-8080 Ext. 21 snunez@southfloridamedicalresearch.com
Marc Gittleman, MD, Principal Investigator
Marc Gittleman, MD, Principal Investigator
Pinellas Urology, St. Petersburg, Florida, 33710, United States; Recruiting
Bronson Oudshoff 727-381-8667 research@pinellasurology.com
Sean Heron, MD, Principal Investigator
Sean Heron, MD, Principal Investigator
Lakeland Regional Medical Center, Lakeland, Florida, 33805, United States; Recruiting
Robin Stewart 863-904-1885 Ext. 1104 robin.stewart@lrmc.com
Byron Hodge, MD, Principal Investigator
Byron Hodge, MD, Principal Investigator
Winter Park Urology Associates, Orlando, Florida, 32803, United States; Recruiting
Sharon Livingstone 407-897-3499 sharonlivingstone@wpuafl.com
David Jablonski, MD, Principal Investigator
David Jablonski, MD, Principal Investigator
Panama City Urology, Panama City Beach, Florida, 32405, United States; Recruiting
Beverly Bond 850-785-8557 pcuresearch@hotmail.com
Mike Jenkins, MD, Principal Investigator
Mike Jenkins, MD, Principal Investigator
Florida Foundation for Healthcare Research, Ocala, Florida, 34474, United States; Recruiting
Joanne Grover 352-237-8100 Ext. 275 jgrover@floridahr.com
Ira Klimberg, MD, Principal Investigator
Ira Klimberg, MD, Principal Investigator
Cleveland Clinic-Florida, Weston, Florida, 33331, United States; Recruiting
Eida Gomez 954-359-5199 gomeze2@ccf.org
Nicholas Muruve, MD, Principal Investigator
Nicholas Muruve, MD, Principal Investigator
Southeastern Research Group, Tallahassee, Florida, 32308, United States; Recruiting
Mary Ann Taylor 850-201-0411 Ext. 470 rschcrc@seuc.com
Raleigh Rollins, MD, Principal Investigator
Raleigh Rollins, MD, Principal Investigator
Advance Research Institute, New Port Richey, Florida, 34652, United States; Recruiting
Nora Merrill 727-842-9561 Ext. 263 merillnari@yahoo.com
Jerrold Sharkey, MD, Principal Investigator
Jerrold Sharkey, MD, Principal Investigator
Urosearch, Inverness, Florida, 34452, United States; Recruiting
352-732-6040 urosearch@atlantic.net
Thomas Stringer, MD, Principal Investigator
Thomas Stringer, MD, Principal Investigator
Urology Consultants Inc., Clearwater, Florida, 33761, United States; Recruiting
Phyllis Wattleworth 727-797-3281 phyllis@urologyconsultantsfla.com
James M Zachary, MD, Principal Investigator
James M Zachary, MD, Principal Investigator
Georgia
Midtown Urology, Atlanta, Georgia, 30308, United States; Recruiting
Nathan Smith 404-881-0965 Ext. 117 nsmith@midtown-urology.com
James K Bennett, MD, Principal Investigator
James K Bennett, MD, Principal Investigator
Augusta VAMC, Augusta, Georgia, 30912, United States; Recruiting
Carol Smith 706-721-0193 csmith@mcg.edu
James A. Brown, MD, Principal Investigator
James A. Brown, MD, Principal Investigator
Harbin Clinic Department of Urology Research, Rome, Georgia, 30165, United States; Recruiting
Sheila Day 706-232-1437 sday@harbinclinic.com
James Crane, Principal Investigator
James Crane, Principal Investigator
Southeastern Medical Research Institute, Columbus, Georgia, 31904, United States; Recruiting
Stepahnie Thomas 706-324-7700 thomass@harperurology.com
William Harper, MD, Principal Investigator
William Harper, MD, Principal Investigator
Georgia Urology, Atlanta, Georgia, 30342, United States; Recruiting
Cheryl Simpson 404-943-1957 cheryl.simpson@gaurology.com
Emerson Harrison, MD, Principal Investigator
Emerson Harrison, MD, Principal Investigator
North Fulton Urology, Roswell, Georgia, 30076, United States; Recruiting
Cindy Nelson 770-752-8632 cnelson@nfurology.com
Lewis Kriteman, MD, Principal Investigator
Lewis Kriteman, MD, Principal Investigator
St. Joseph''''s, Candler Health System, Savannah, Georgia, 31405, United States; Recruiting
Wanda North 912-819-6194 northw@sjchs.org
Richard Mazo, MD, Principal Investigator
Richard Mazo, MD, Principal Investigator
Urology Enterprises, Marietta, Georgia, 30060, United States; Recruiting
Becky Hippensteel 770-428-6478 beckyhippensteel@yahoo.com
Ronald Roper, MD, Principal Investigator
Ronald Roper, MD, Principal Investigator
St. Joseph Research Institute, Atlanta, Georgia, 30342, United States; Recruiting
Rhonda Kendrick 404-255-3822 rkendrick@sjha.org
Holt Sanders, MD, Principal Investigator
Holt Sanders, MD, Principal Investigator
Idaho
North Idaho Urology, Coeur D Alene, Idaho, 83814, United States; Recruiting
Pat Vancaster 208-667-0621 pvancaster@niurology.com
Randil Clark, MD, Principal Investigator
Randil Clark, MD, Principal Investigator
Illinois
Special Care Research, Peoria, Illinois, 61614, United States; Recruiting
Dawn Wimmer 309-683-1125 puareasearch@yahoo.com
Giovanni Columbo, MD, Principal Investigator
Giovanni Columbo, MD, Principal Investigator
Prairie Medical Associates, Chicago, Illinois, 60616, United States; Recruiting
Urakay Juett 312-842-4400 urakay@urologychicago.com
Terry Mason, MD, Principal Investigator
Terry Mason, MD, Principal Investigator
Medical and Surgical Specialists, Galesburg, Illinois, 61401, United States; Recruiting
Gina Riner 309-343-2262 griner@grics.net
Thomas Patterson, MD, Principal Investigator
Thomas Patterson, MD, Principal Investigator
Indiana
Metropolitan Urology, Jeffersonville, Indiana, 47130, United States; Recruiting
Debbie Johnson 812-288-2611 d.johnson@metropolitanurology.com
James Bailen, MD, Principal Investigator
James Bailen, MD, Principal Investigator
Urology of Indiana, LLC, Greenwood, Indiana, 46143, United States; Recruiting
Angie Summers 317-893-1511 asummers@urologyin.com
Terry Jones, MD, Principal Investigator
Terry Jones, MD, Principal Investigator
MMPC Urology, Greenwood, Indiana, 49546, United States; Recruiting
Sue Engerman 616-974-4604 sengerman@mmpc.com
Richard Kahnoski, MD, Principal Investigator
Richard Kahnoski, MD, Principal Investigator
Kansas
Heartland Research Associates, LLC, Wichita, Kansas, 67207, United States; Recruiting
Sheri L. Duncan 316-689-6635 sduncan@heartlandresearch.com
Terry Poling, MD, Principal Investigator
Terry Poling, MD, Principal Investigator
Louisiana
Regional Urology LLC, Shreveport, Louisiana, 71106, United States; Recruiting
Leah Stehr 318-683-0411 Ext. 154 lstehr@regionalurology.com
David Price, MD, Principal Investigator
David Price, MD, Principal Investigator
LSUHSC/Stanley Scott Cancer Center, New Orleans, Louisiana, 70112, United States; Recruiting
Alisa Trout 504-568-8286 atrout@lsuhsc.edu
Oliver Sartor, MD, Principal Investigator
Oliver Sartor, MD, Principal Investigator
Maryland
Urology Center, PA, Hagerstown, Maryland, 21742, United States; Recruiting
Dan Lemont 301-733-0022 dwarek@aol.com
Kevin Hackett, MD, Principal Investigator
Kevin Hackett, MD, Principal Investigator
Maryland Prostate Center: University of Maryland Medical Center, Baltimore, Maryland, 21201, United States; Recruiting
Ganine Markowitz 410-328-0801 gmarkowitz@smail.umaruland.edu
Michael Naslund, MD, Principal Investigator
Michael Naslund, MD, Principal Investigator
Anne Arundel Urology P.A., Annapolis, Maryland, 21401, United States; Recruiting
Elizabeth D''''Antonio 410-266-8049 Ext. 143 landantonio@aaurology.com
Eric Schwartz, MD, Principal Investigator
Eric Schwartz, MD, Principal Investigator
Mid Atlantic Clinical Research, Rockville, Maryland, 28050, United States; Recruiting
Jackie Rosario 301-315-6081 rosariojackie1@msn.com
Jonathan White, MD, Principal Investigator
Jonathan White, MD, Principal Investigator
Massachusetts
The Fallon Clinic, Worcester, Massachusetts, 01605, United States; Recruiting
Diane Davis 508-595-2195 diane.davis@fallon-clinic.com
Mitchell Bamberger, MD, Principal Investigator
Mitchell Bamberger, MD, Principal Investigator
Wayne Glazier, Worcester, Massachusetts, 01605, United States; Recruiting
Linda Dodge 508-753-1298 dodgeaprn006@yahoo.com
Wayne Glazier, MD, Principal Investigator
Wayne Glazier, MD, Principal Investigator
Michigan
Beaumont Medical, Royal Oak, Michigan, 48073, United States; Recruiting
Melissa Degraw 248-551-0804 madegraw@beaumont.edu
Ananias Diokno, MD, Principal Investigator
Ananias Diokno, MD, Principal Investigator
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States; Recruiting
Cynthia Rekowski 734-647-9437 crekowsk@umich.edu
Ken Pienta, MD, Principal Investigator
Ken Pienta, MD, Principal Investigator
Minnesota
Park Nicollet Urology, St. Louis Park, Minnesota, 55416, United States; Recruiting
Linda Kuno 952-993-1926 kunol@parknicollet.com
William Borkon, MD, Principal Investigator
William Borkon, MD, Principal Investigator
Mayo Clinic Urology Department, Rochester, Minnesota, 55905, United States; Recruiting
Jane Smith 507-266-4446 smith.jane2@mayo.edu
Ajay Nehra, MD, Principal Investigator
Ajay Nehra, MD, Principal Investigator
Missouri
Urologic Research Center, St. Louis, Missouri, 63141, United States; Not yet recruiting
Karen Civitelli 314-996-8282 civitellik@wash.edu
Arnold Bullock, MD, Principal Investigator
Arnold Bullock, MD, Principal Investigator
PPS Clinical Research, St. Louis, Missouri, 63141, United States; Recruiting
Marilyn Cauley 314-692-8013 mcauley@ppscr.com
Jay Patel, MD, Principal Investigator
Jay Patel, MD, Principal Investigator
Kansas City Urology, PC, Kansas, Missouri, 64131, United States; Recruiting
Shannon Cone 816-333-5433 scone@kcurology.com
Brandon Pomeroy, MD, Principal Investigator
Brandon Pomeroy, MD, Principal Investigator
Nevada
Sheldon Freeman, Las Vegas, Nevada, 89109, United States; Recruiting
Syd Warner 702-732-0282 sydwarner@yahoo.com
Sheldon Freedman, MD, Principal Investigator
Sheldon Freedman, MD, Principal Investigator
Urologic Surgeons, Ltd., Reno, Nevada, 89502, United States; Not yet recruiting
Lorry Duncan 775-284-1614 lduncan@urosurg.net
John Scott, MD, Principal Investigator
John Scott, MD, Principal Investigator
New Jersey
Urology Healthcare Associates, Willingboro, New Jersey, 08046, United States; Recruiting
Marilyn Behler, RN 609-877-8400 pmb@fast.net
Scott Asroff, MD, Principal Investigator
Scott Asroff, MD, Principal Investigator
Coastal Urology Associates, Brick, New Jersey, 08724, United States; Recruiting
Susan Messler 732-840-4300 snaponpete@zaol.com
Daniel Burzon, MD, Principal Investigator
Daniel Burzon, MD, Principal Investigator
Lawrenceville Urology Associates, Lawrenceville, New Jersey, 08648, United States; Recruiting
Beverly Davis 609-895-0735 Ext. 110 bev.davis05@comcast.net
Gary S Karlin, MD, Principal Investigator
Gary S Karlin, MD, Principal Investigator
Hamilton Urology PA, Hamilton, New Jersey, 08690, United States; Recruiting
Sukanya Skanbarajah 609-588-5300 sskanbarajah@odesseyresearch.org
Earl Linder, MD, Principal Investigator
Earl Linder, MD, Principal Investigator
Assoc. Urologic Specialists, Marlton, New Jersey, 08053, United States; Recruiting
Beverly Pfeifer 856-985-4286 bpfeiferausnj.com
Neil Phillips, MD, Principal Investigator
Neil Phillips, MD, Principal Investigator
New Mexico
Urology Group of New Mexico, Albuquerque, New Mexico, 87109, United States; Recruiting
Carla Jennings 505-872-4090 Ext. 118 research@ugnm.com
Frederick Snoy, MD, Principal Investigator
Frederick Snoy, MD, Principal Investigator
New York
Center for Urologic Research WNY, LLC, Williamsville, New York, 14221, United States; Recruiting
Debbie D''''Orazio, RN, CCRC 716-631-9654 pjaresearchofwny@mainurology.com
Phillip Aliotta, MD, Principal Investigator
Phillip Aliotta, MD, Principal Investigator
Metropolitan Urologic Services, PC, Elmont, New York, 11003, United States; Recruiting
Carlos Saavedra 516-328-8775 metrouro@aol.com
Carlton Barnswell, MD, Principal Investigator
Carlton Barnswell, MD, Principal Investigator
Urological Surgeons of Long Island, Garden City, New York, 11530, United States; Recruiting
Marissa Schulman 516-742-3200 golmy@aol.com
Robert Edelman, MD, Principal Investigator
Robert Edelman, MD, Principal Investigator
Urology Inst. Of New York, Albany, New York, 12208, United States; Recruiting
Brenda Romeo 518-262-8579 ccpurologyresearch@communitycare.com
Hugh Fisher, MD, Principal Investigator
Hugh Fisher, MD, Principal Investigator
Mount Sinai School of Medicine, New York, New York, 10029, United States; Recruiting
Cynthia Knauer 212-241-8121 cynthia.knauer@mountsinai.org
Simon Hall, MD, Principal Investigator
Simon Hall, MD, Principal Investigator
Staten Island Urological Research , PC, Staten Island, New York, 10304, United States; Recruiting
Nicole Zampardi 718-720-6040 urology2@si.rr.com
Ron Israeli, MD, Principal Investigator
Ron Israeli, MD, Principal Investigator
University Urology Associates, New York, New York, 10016, United States; Recruiting
Betsy Ortiz 212-686-9015 betsyortiz@yahoo.com
Jed Kaminetsky, MD, Principal Investigator
Jed Kaminetsky, MD, Principal Investigator
Associated Urologists of CNY, Syracuse, New York, 13210, United States; Recruiting
Michelle Bass 315-478-4185 mbass@twcny.rr.com
Joel Bass, MD, Principal Investigator
Joel Bass, MD, Principal Investigator
William Oberheim, Albany, New York, 12208, United States; Recruiting
Cheryl Aikey 518-438-4471 ewilliamsoberh@nycap.rr.com
William Oberheim, MD, Principal Investigator
William Oberheim, MD, Principal Investigator
CNY Urology, Oneida, New York, 13421, United States; Recruiting
Kimberly Barres 315-363-8862 cnyurology@yahoo.com
Basha Omarbasha, MD, Principal Investigator
Basha Omarbasha, MD, Principal Investigator
North Carolina
University of North Carolina, Chapel Hill, North Carolina, 27559, United States; Recruiting
Cooki Senter 919-966-9253 cooki_senter@med.va.gov
Cully Carson, MD, Principal Investigator
Cully Carson, MD, Principal Investigator
Piedmont Medical Research Associates, Winston Salem, North Carolina, 27103, United States; Recruiting
Emily Cook 336-768-8062 ecook@piedmontmedical.com
David Cook, MD, Principal Investigator
David Cook, MD, Principal Investigator
Asheboro Urology, Asheboro, North Carolina, 27203, United States; Recruiting
Debbie Davis 336-625-3997 christie.barnes@earthlink.net
Prithivi Hanspal, MD, Principal Investigator
Prithivi Hanspal, MD, Principal Investigator
Wake Urology, Raleigh, North Carolina, 27607, United States; Recruiting
Mary Hester 919-782-1255 wakeurol@aol.com
Richard Kane, MD, Principal Investigator
Richard Kane, MD, Principal Investigator
The Urology Center, Greensboro, North Carolina, 27403, United States; Recruiting
Jillian Angel 336-274-1114 Ext. 5383 jangel@tucpa.com
Sigmund Tannenbaum, MD, Principal Investigator
Sigmund Tannenbaum, MD, Principal Investigator
North Dakota
Odyssey Research, Bismarck, North Dakota, 58501, United States; Recruiting
Laurie Holverson 701-250-8420 lholverson@odysseyresearch.org
Leslie Rainwater, MD, Principal Investigator
Leslie Rainwater, MD, Principal Investigator
Ohio
Southwest Urology, Parma, Ohio, 44129, United States; Recruiting
Kim Cristantiello 440-845-0900 southwest@southwesturology.com
Michael Berte, MD, Principal Investigator
Michael Berte, MD, Principal Investigator
Colombus Urology Research, Columbus, Ohio, 43214, United States; Recruiting
Janice Rosenthal 614-457-6028 pam@columbusurology.com
David H. Brown, MD, Principal Investigator
David H. Brown, MD, Principal Investigator
Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, 44195, United States; Recruiting
Benjamin Haraway 216-445-4623 harawab@ccf.org
Robert Dreicer, MD, Principal Investigator
Robert Dreicer, MD, Principal Investigator
The Urology Group, Cincinnati, Ohio, 45212, United States; Recruiting
Vicki Rice 513-366-3412 vrice@theurologygroup.cc
William Monnig, MD, Principal Investigator
William Monnig, MD, Principal Investigator
Summa Health Care, Akron, Ohio, 44304, United States; Recruiting
Nancy Rinella 330-375-4221 rinellan@summa-health.org
Michael ` Seider, MD, Principal Investigator
Michael ` Seider, MD, Principal Investigator
Urology of Northern Ohio, Elyria, Ohio, 44035, United States; Recruiting
Diane Spirnak 440-930-6060 papirnak@metrohealth.org
J.P. Spirnak, MD, Principal Investigator
J.P. Spirnak, MD, Principal Investigator
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Karen Mataranglo 405-271-6900 Karen-Mataranglo@ouhsc.edu
Daniel Culkin, MD, Principal Investigator
Daniel Culkin, MD, Principal Investigator
Urologic Specialists of Oklahoma, Inc., Tulsa, Oklahoma, 12208, United States; Recruiting
June Jordan 918-392-2290 jjordan@urologicspecialists.com
John Forrest, MD, Principal Investigator
John Forrest, MD, Principal Investigator
Oregon
The Corvallis Clinic, Corvallis, Oregon, 97330, United States; Recruiting
Pat Eshelman 541-753-1618 Ext. 1029 pat.eshleman@corvallis-clinic.com
Peter Kenyon, MD, Principal Investigator
Peter Kenyon, MD, Principal Investigator
Oregon Urology Specialists, Springfield, Oregon, 97477, United States; Recruiting
Janice Beebe 541-284-5508
Bryan Mehlhaff, MD, Principal Investigator
Bryan Mehlhaff, MD, Principal Investigator
Pennsylvania
Urologic Surgery, Bala Cynwyd, Pennsylvania, 19004, United States; Recruiting
Cheryl Zinar 610-667-3020 Ext. 16 urologicresearch@attglobal.net
Lawrence Belkoff, MD, Principal Investigator
Lawrence Belkoff, MD, Principal Investigator
The Urology Institute, Monroeville, Pennsylvania, 15146, United States; Recruiting
Julie Bachalis 412-373-2333 jmbachalis@hotmail.com
Frank Costa, MD, Principal Investigator
Frank Costa, MD, Principal Investigator
State College Urologic Association, State College, Pennsylvania, 16801, United States; Recruiting
Amy Folk 814-238-8418 folka@scurologic
Charles Dalton, MD, Principal Investigator
Charles Dalton, MD, Principal Investigator
University of Pittsburg, Pittsburg, Pennsylvania, 15232, United States; Recruiting
Colette Spinarelli 412-605-3031 colette.spinarelli@med.va.gov
Jeff Gingrich, MD, Principal Investigator
Jeff Gingrich, MD, Principal Investigator
Ginsberg and Harkaway Urology, Philadelphia, Pennsylvania, 19141, United States; Recruiting
Rose Mary Sandy 215-456-1177 sandyr@einstein.edu
Phillip Ginsberg, MD, Principal Investigator
Phillip Ginsberg, MD, Principal Investigator
University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Lilliam Ribeiro 215-615-3780 lilliam.ribeiro@uphs.upenn.edu
Bruce Malkowicz, MD, Principal Investigator
Bruce Malkowicz, MD, Principal Investigator
Urologic Associates of Allentown, Allentown, Pennsylvania, 18103, United States; Recruiting
Kathleen Post 610-437-9988 kathleen.post@lvh.com
Brian Murphy, MD, Principal Investigator
Brian Murphy, MD, Principal Investigator
University of Pittsburgh, Pittsburgh, Pennsylvania, 15232, United States; Recruiting
Lauri-Ann Hahn 412-605-3031 hahnla@upmc.edu
Joel Nelson, MD, Principal Investigator
Joel Nelson, MD, Principal Investigator
Urological Associates of Lancaster, Ltd., Lancaster, Pennsylvania, 17604, United States; Recruiting
Dorie Rodriguez 717-431-2285 ualresearch@yahoo.com
Paul Sieber, MD, Principal Investigator
Paul Sieber, MD, Principal Investigator
Rhode Island
University Urological Research Institute, Providence, Rhode Island, 02904, United States; Recruiting
Betsy Parrott 401-272-7799 bparrott@urologyri.com
Barry Stein, MD, Principal Investigator
Barry Stein, MD, Principal Investigator
South Carolina
Carolina Urologic Research Center, Myrtle Beach, South Carolina, 29572, United States; Recruiting
Stacey Harrelson 843-839-1679 sharrel@grandstrandurology.com
Brian Roberts, MD, Principal Investigator
Brian Roberts, MD, Principal Investigator
Radiant Research, Greer, South Carolina, 29651, United States; Recruiting
Heather Warner 864-877-9239 heatherwarner@radiantresearch.com
John Walton, MD, Principal Investigator
John Walton, MD, Principal Investigator
Tennessee
Urology Associates, Nashville, Tennessee, 37209, United States; Recruiting
Rick Trotter 615-250-9268 crtrotter@cimplify.net
David Bilhartz, MD, Principal Investigator
David Bilhartz, MD, Principal Investigator
Vanderbilt Medical Center, Nashville, Tennessee, 37232, United States; Recruiting
Pam Steele 615-343-0445 pam.steele@vanderbilt.edu
Michael Cookson, MD, Principal Investigator
Michael Cookson, MD, Principal Investigator
Volunteer Research Group, Knoxville, Tennessee, 37920, United States; Recruiting
Carla Spurgeon 865-544-9356 cspurgeo@mc.utmck.edu
Paul Hatcher, MD, Principal Investigator
Paul Hatcher, MD, Principal Investigator
Center for Urological Treatment, Nashville, Tennessee, 37203, United States; Recruiting
Rhayghen Ashby 615-342-5700 rhayghenashby@hotmail.com
Dean Knoll, MD, Principal Investigator
Dean Knoll, MD, Principal Investigator
Southeast Urology Network, Memphis, Tennessee, 38119, United States; Recruiting
T.J. Brace 901-527-7100 tjbrace@mdnet.net
Mark Saslawsky, MD, Principal Investigator
Mark Saslawsky, MD, Principal Investigator
Ace Research Specialists, Nashville, Tennessee, 37203, United States; Recruiting
Debbie Shepherd 615-844-1223 aceresearch@earthlink.net
Michael Spalding, MD, Principal Investigator
Michael Spalding, MD, Principal Investigator
Texas
Professional Quality Research, Austin, Texas, 78756, United States; Recruiting
Amy Sasser 512-374-1677 Ext. 16 asasser@pqrinc.com
Richard Chopp, MD, Principal Investigator
Richard Chopp, MD, Principal Investigator
Breco Research, Houston, Texas, 77024, United States; Recruiting
Patricia Mendoza 713-973-6993 pmendoza@brecoresearch.com
Mark Kalish, MD, Principal Investigator
Mark Kalish, MD, Principal Investigator
Scott and White Clinical Hospital, Temple, Texas, 76508, United States; Recruiting
Karen Wynn 254-724-5512 sdstern@swmail.sw.org
Belur Patel, MD, Principal Investigator
Belur Patel, MD, Principal Investigator
Urology San Antonio Research, PA, San Antonio, Texas, 78229, United States; Recruiting
Diana Strange 210-617-4116 dianas@urologysanantonio.com
Daniel Saltzstein, MD, Principal Investigator
Daniel Saltzstein, MD, Principal Investigator
Urology Consultants, PA, San Antonio, Texas, 78229, United States; Recruiting
Kimberly Paz 210-616-0410 research@urologyconsults.com
Sammy Vick, MD, Principal Investigator
Sammy Vick, MD, Principal Investigator
Utah
Salt Lake City Research, Salt Lake City, Utah, 84124, United States; Recruiting
Heather Drips 801-288-9778 heatherlyndrips@yahoo.com
Lane Childs, MD, Principal Investigator
Lane Childs, MD, Principal Investigator
Virginia
Devine Tidewater Urology, Norfolk, Virginia, 23502, United States; Recruiting
Bethany Gambill 757-457-5164 bgambill@urologyofva.com
Robert Given, MD, Principal Investigator
Robert Given, MD, Principal Investigator
McGuire VA Medical Center, Richmond, Virginia, 23249, United States; Recruiting
Pamela Summers 804-675-5409 pamela.summers@med.va.gov
Mayer Grob, MD, Principal Investigator
Mayer Grob, MD, Principal Investigator
Med Atlantic, Inc (Virginia Urology), Richmond, Virginia, 23235, United States; Recruiting
Nada Wood 804-560-4483 nada @uro.com
James McMurtry, MD, Principal Investigator
James McMurtry, MD, Principal Investigator
Adult and Pediatric Urologist of Northern VA, Alexandria, Virginia, 22304, United States; Recruiting
Barbara Chalom 703-370-2132 chalomb@comcast.net
George Tawil, MD, Principal Investigator
George Tawil, MD, Principal Investigator
Washington
Deaconess Medical Center, Spokane, Washington, 99204, United States; Recruiting
Monica Ponder 509-473-3480 ponderm@empirehealth.org
Thomas Fairchild, MD, Principal Investigator
Thomas Fairchild, MD, Principal Investigator
Seattle VAMC, Seattle, Washington, 98108, United States; Recruiting
Judy Stenstrom 206-277-4368 judy.stenstrom@med.va.gov
Daniel Lin, MD, Principal Investigator
Daniel Lin, MD, Principal Investigator
Madigan Army Medical Center, Tacoma, Washington, 98431, United States; Recruiting
Tammy Bousquet-Cordes 253-968-0798
Keith O''''Reilly, MD, Principal Investigator
Keith O''''Reilly, MD, Principal Investigator
Wisconsin
Froedtert Memorial Lutheran Hospital Department of Urology, Milwaukee, Wisconsin, 53226, United States; Recruiting
Holly Kelly 414-456-7059 hkelly@mail.mcw.edu
Robert Donnell, Principal Investigator
Robert Donnell, Principal Investigator
University of Wisconsin Medical School: Clinical Trials, Madison, Wisconsin, 53715, United States; Recruiting
Barbara Bowman 608-287-2861 bab@clinicaltrials.wisc.edu
David Paolone, MD, Principal Investigator
David Paolone, MD, Principal Investigator
St. Michael''''s Hospital, Milwaukee, Wisconsin, 53209, United States; Recruiting
Ann Dwyer 414-527-3056 adwyer@midwestresearch.net
Mitchell Wiatrak, MD, Principal Investigator
Mitchell Wiatrak, MD, Principal Investigator
Wyoming
Wyoming Research Foundation, Cheyenne, Wyoming, 82001, United States; Recruiting
Deb Patterson 307-637-8183 wyomingresearch@yahoo.com
John Bryant, MD, Principal Investigator
John Bryant, MD, Principal Investigator
Study chairs or principal investigators
Robert S. Boger, M.D., Study Director, GTx
More Information
Study ID Numbers: G300203
Last Updated: August 10, 2005
Record first received: August 9, 2005
ClinicalTrials.gov Identifier: NCT00129142
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 10, 2005
Record first received: August 9, 2005
ClinicalTrials.gov Identifier: NCT00129142
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- (National Women's Health Information Center, OWH, HHS)
- 1999 Federal Government TTY Directory (Federal Citizen Information Center, GSA)
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