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Last Modified: 7/3/2009     First Published: 1/25/2007  
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Phase III Randomized Study of Radical Prostatectomy With Versus Without Neoadjuvant Chemohormonal Therapy Comprising Docetaxel and Androgen-Deprivation Therapy With Leuprolide Acetate or Goserelin in Patients With High-Risk, Clinically Localized Prostate Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCICALGB-90203
NCT00430183

Special Category: CTSU trial, NCI Web site featured trial

Objectives

Primary

  1. Compare the rate of 3-year biochemical progression-free survival (bPFS) in patients with high-risk, clinically localized prostate cancer treated with radical prostatectomy with vs without neoadjuvant chemohormonal therapy comprising docetaxel and androgen-deprivation therapy with leuprolide acetate or goserelin.

Secondary

  1. Compare the 5-year bPFS rate, bPFS, disease progression, disease-free survival, and overall survival of patients treated with these regimens.
  2. Determine the safety and tolerability of neoadjuvant docetaxel and androgen-deprivation therapy in these patients.
  3. Compare the time to clinically apparent local disease recurrence and metastatic disease in patients treated with these regimens.
  4. Compare pathologic tumor stage, frequency of lymph node metastases, and positive margin rates in patients treated with these regimens.
  5. Determine if changes in serum testosterone levels will predict bPFS in these patients.
  6. Determine, prospectively, whether prostate-specific antigen doubling time is a surrogate endpoint for time to clinical metastases and overall survival in these patients.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed adenocarcinoma of the prostate
    • No small cell, neuroendocrine, or transitional cell carcinoma


  • Clinically localized, stage T1-3a disease


  • No radiographic evidence of metastatic disease*, as demonstrated by all of the following:
    • No lymph nodes > 1 cm by CT scan or MRI of the abdomen and pelvis or endorectal MRI of the pelvis
      • A negative biopsy required for lymph node(s) that measure > 1 cm
        • If > 1 lymph node is > 1 cm, the largest or most accessible node is biopsied
    • Negative bone scan with plain films and/or MRI/CT scan confirmation, if necessary

     [Note: *Positive positron emission tomography scan and Prostascint scans are not considered proof of metastatic disease]



  • Serum prostate-specific antigen level ≤ 100 ng/mL within the past 6 weeks


  • Patients must have a known Gleason sum based on biopsy or TURP at study entry


  • High-risk disease, meeting 1 of the following criteria:
    • Probability of biochemical progression-free survival at 5 years after surgery < 60% by Kattan nomogram prediction
    • Biopsy Gleason score 8 to 10


  • Deemed an appropriate candidate for radical prostatectomy


Prior/Concurrent Therapy:

  • No prior treatment for prostate cancer, including surgery, pelvic lymph node dissection, radiotherapy, or chemotherapy
    • Prior transurethral resection of prostate allowed
  • Prior androgen-deprivation therapy (e.g., luteinizing hormone-releasing hormone agonists, antiandrogens, or both) lasting ≤ 3 months allowed
  • Concurrent systemic anticoagulation allowed
  • No concurrent oral antiandrogens
  • No concurrent aprepitant
  • No other concurrent chemotherapeutic agents except for any of the following:
    • Steroids given for adrenal failure
    • Hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
    • Intermittent use of dexamethasone as an antiemetic or as pretreatment for patients receiving docetaxel

Patient Characteristics:

  • ECOG performance status 0-2
  • Life expectancy > 10 years
  • Absolute neutrophil count ≥ 1,500/mm3
  • Platelet count ≥ 150,000/mm3
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin normal (≤ 2.5 times upper limit of normal [ULN] for patients with Gilbert’s disease)
  • AST and ALT ≤ 1.5 times ULN
  • Fertile patients must use effective contraception during and for ≥ 2 months after completion of study treatment
  • Not at high risk for cardiac complications
    • Prior deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident allowed

Expected Enrollment

750

A total of 750 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

3-year biochemical progression-free survival (bPFS) rate

Secondary Outcome(s)

5-year bPFS rate and bPFS
Time to clinical local recurrence
Time to metastatic disease progression
Unacceptable toxicity
Prostate cancer-specific-free survival
Disease progression
Overall survival
Death

Outline

This is a multicenter, randomized study. Patients are stratified according to nomogram-predicted biochemical progression-free survival at 5 years (0-20.9% vs 21-39.9% vs 40-59.9% vs ≥ 60%) and androgen-deprivation therapy in the past 3 months (no vs yes). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive goserelin subcutaneously or leuprolide acetate intramuscularly once every 4 or 12 weeks for 18-24 weeks. They also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 3 weeks for up to 6 courses. Within 60 days after completion of chemohormonal therapy, patients undergo radical prostatectomy with staging pelvic lymphadenectomy.


  • Arm II: Within 60 days after randomization, patients undergo radical prostatectomy with staging pelvic lymphadenectomy.


After completion of study therapy, patients are followed at 1 and 3 months and then periodically for up to 15 years.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

James Eastham, MD, Protocol chair
Ph: 646-422-4390; 800-525-2225

Eastern Cooperative Oncology Group

Martin Sanda, MD, Protocol chair
Ph: 617-667-2960

NCIC-Clinical Trials Group

Martin Gleave, MD, Protocol chair
Ph: 604-875-5003

Trial Sites

U.S.A.
Alaska
  Anchorage
 Providence Cancer Center
 Clinical Trials Office - Providence Cancer Center
Ph: 907-261-3109
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Ph: 501-686-8274
California
  Berkeley
 Alta Bates Summit Comprehensive Cancer Center
 Clinical Trials Office - Alta Bates Summit Comprehensive Cancer Center
Ph: 510-204-3428
  Burbank
 Providence Saint Joseph Medical Center - Burbank
 Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank
Ph: 818-847-3220
  Burlingame
 Peninsula Medical Center
 David Irwin, MD
Ph: 510-204-1591
  Duarte
 City of Hope Comprehensive Cancer Center
 Clinical Trials Office - City of Hope Comprehensive Cancer Center
Ph: 800-826-4673
 Email: becomingapatient@coh.org
  Greenbrae
 Marin Cancer Institute at Marin General Hospital
 David Irwin, MD
Ph: 510-204-1591
 Sutter Health - Western Division Cancer Research Group
 David Irwin, MD
Ph: 510-204-1591
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center
Ph: 858-822-5354
 Email: cancercto@ucsd.edu
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital
Ph: 323-865-0451
  Sacramento
 University of California Davis Cancer Center
 Clinical Trials Office - University of California Davis Cancer Center
Ph: 916-734-3089
  San Diego
 Veterans Affairs Medical Center - San Diego
 Barbara Parker
Ph: 858-552-8585
  San Francisco
 California Pacific Medical Center - California Campus
 David Irwin, MD
Ph: 510-204-1591
 UCSF Helen Diller Family Comprehensive Cancer Center
 Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center
Ph: 877-827-3222
  Vallejo
 Sutter Solano Medical Center
 David Irwin, MD
Ph: 510-204-1591
Connecticut
  West Haven
 Veterans Affairs Medical Center - West Haven
 Edward Uchio
Ph: 203-937-3421
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Clinical Trials Office - Tunnell Cancer Center
Ph: 302-645-3171
  Newark
 CCOP - Christiana Care Health Services
 Clinical Trial Office - CCOP - Christiana Care Health Services
Ph: 302-733-6227
District of Columbia
  Washington
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Clinical Trials Office - Lombardi Comprehensive Cancer Center
Ph: 202-444-0381
 Walter Reed Army Medical Center
 Clinical Trials Office - Walter Reed Army Medical Center
Ph: 202-782-7840
Florida
  Fort Lauderdale
 Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
 Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center
Ph: 954-776-3239
  Jupiter
 Ella Milbank Foshay Cancer Center at Jupiter Medical Center
 Clinical Trials Office - Ella Milbank Foshay Cancer Center
Ph: 561-745-5768
  Leesburg
 Cancer Centers of Central Florida, PA
 Donald Elmajian, MD
Ph: 318-813-1200
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Rogerio Lilenbaum, MD
Ph: 305-535-3310
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Clinical Trials Office - Florida Hospital Cancer Institute
Ph: 407-303-5623
  Weston
 Cleveland Clinic Florida - Weston
 Clinical Trials Office - Cleveland Clinic Florida - Weston
Ph: 954-659-5705
Illinois
  Alton
 Saint Anthony's Hospital at Saint Anthony's Health Center
 Bethany Sleckman, MD
Ph: 314-251-7057
  Chicago
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
  Evanston
 Evanston Hospital
 Clinical Trials Office - Evanston Hospital
Ph: 847-570-1381
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kendrith Rowland, MD
Ph: 217-383-3019
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Clinical Trials Office - Cardinal Bernardin Cancer Center
Ph: 708-226-4357
  Mt. Vernon
 Good Samaritan Regional Health Center
 Bethany Sleckman, MD
Ph: 314-251-7057
  Normal
 Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
 John Migas, MD
Ph: 309-451-2207
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard Gross, MD
Ph: 937-832-1093
  Elkhart
 Elkhart General Hospital
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Goshen
 Center for Cancer Care at Goshen General Hospital
 Clinical Trials Office - Center for Cancer Care at Goshen General Hospital
Ph: 574-535-2858
  Kokomo
 Howard Community Hospital
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Richmond
 Reid Hospital & Health Care Services
 Howard Gross, MD
Ph: 937-832-1093
  South Bend
 CCOP - Northern Indiana CR Consortium
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Memorial Hospital of South Bend
 Clinical Trials Office - Memorial Hospital of South Bend
Ph: 800-284-7370
 Saint Joseph Regional Medical Center
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 South Bend Clinic
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
Iowa
  Bettendorf
 Hematology Oncology Associates of the Quad Cities
 Shobha Chitneni, MD, MBBS
Ph: 563-355-7733
  Davenport
 Genesis Medical Center - West Campus
 George Kovach, MD
Ph: 563-421-1960
 Genesis Regional Cancer Center at Genesis Medical Center
 George Kovach, MD
Ph: 563-421-1960
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Cancer Information Service
Ph: 800-237-1225
 Veterans Affairs Medical Center - Iowa City
 Daniel Vaena
Ph: 319-338-0581
800-637-0128
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Ph: 913-588-4709
  Olathe
 Olathe Cancer Center
 Karen Kelly, MD
Ph: 303-724-3903
Kentucky
  Lexington
 Lucille P. Markey Cancer Center at University of Kentucky
 Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center
Ph: 859-257-3379
Louisiana
  Shreveport
 Feist-Weiller Cancer Center at Louisiana State University Health Sciences
 Clinical Trials Office - Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Ph: 318-813-1412
 Highland Clinic
 Donald Elmajian, MD
Ph: 318-813-1200
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Ph: 410-955-8804
 Email: jhcccro@jhmi.edu
  Elkton MD
 Union Hospital Cancer Program at Union Hospital
 Stephen Grubbs, MD
Ph: 302-366-1200
  Salisbury
 Peninsula Regional Medical Center
 Clinical Trials Office - Peninsula Regional Medical Center
Ph: 410-543-7000
Massachusetts
  Pittsfield
 Berkshire Hematology Oncology, PC
 Harvey Zimbler, MD
Ph: 413-496-8205
Michigan
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Martin Bury
Ph: 616-966-8000
  Big Rapids
 Mecosta County Medical Center
 Martin Bury
Ph: 231-796-8691
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Clinical Trials Office - Barbara Ann Karmanos Cancer Institute
Ph: 313-576-9363
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Martin Bury
Ph: 616-391-2799
 CCOP - Grand Rapids
 Martin Bury
Ph: 616-391-1230
 Lacks Cancer Center at Saint Mary's Health Care
 Martin Bury
Ph: 616-752-5222
  Muskegon
 Mercy General Health Partners
 Martin Bury
Ph: 231-672-2000
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Traverse City
 Munson Medical Center
 Martin Bury
Ph: 231-935-6202
  Wyoming
 Metro Health Hospital
 Martin Bury
Ph: 616-252-7200
Minnesota
  Alexandria
 Harold Windschitl, MD
Ph: 320-229-4907
  Burnsville
 Fairview Ridges Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Hutchinson
 Hutchinson Area Health Care
 Daniel Anderson
Ph: 320-234-5000
800-454-3903
  Lichfield
 Meeker County Memorial Hospital
 Clinical Trials Office - Meeker County Memorial Hospital
Ph: 320-693-4520
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Daniel Anderson
Ph: 651-232-7970
 Minnesota Oncology Hematology, PA - Maplewood
 Patrick Flynn, MD
Ph: 612-863-8585
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Clinical Trials Office - Hennepin County Medical Center - Minneapolis
Ph: 612-873-5911
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
  Saint Cloud
 CentraCare Clinic - River Campus
 Harold Windschitl, MD
Ph: 320-229-4907
 Coborn Cancer Center
 Harold Windschitl, MD
Ph: 320-229-4907
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick Flynn, MD
Ph: 612-863-8585
 Park Nicollet Cancer Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Saint Paul
 United Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Sartell
 Adult and Pediatric Urology, PLLP
 Donald Jurgens
Ph: 320-259-1411
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  St. Paul
 Regions Hospital Cancer Care Center
 Clinical Trials Office - Regions Hospital Cancer Care Center
Ph: 651-254-1517
  Waconia
 Ridgeview Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Patrick Flynn, MD
Ph: 612-863-8585
Missouri
  Cape Girardeau
 Saint Francis Medical Center
 Bethany Sleckman, MD
Ph: 314-251-7057
 Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
 Bethany Sleckman, MD
Ph: 314-251-7057
  Saint Louis
 CCOP - St. Louis-Cape Girardeau
 Bethany Sleckman, MD
Ph: 314-251-7057
 David C. Pratt Cancer Center at St. John's Mercy
 Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy
Ph: 314-251-6770
 Midwest Hematology Oncology Group, Incorporated
 Bethany Sleckman, MD
Ph: 314-251-7057
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Joel Picus, MD
Ph: 314-362-5737
Montana
  Billings
 Billings Clinic - Downtown
 Clinical Trials Office - Billings Clinic - Downtown
Ph: 800-996-2663
 Email: research@billingsclinic.org
 CCOP - Montana Cancer Consortium
 Benjamin Marchello, MD
Ph: 406-238-6290
 Hematology-Oncology Centers of the Northern Rockies - Billings
 Benjamin Marchello, MD
Ph: 406-238-6290
 Northern Rockies Radiation Oncology Center
 Benjamin Marchello, MD
Ph: 406-238-6290
 St. Vincent Healthcare Cancer Care Services
 Benjamin Marchello, MD
Ph: 406-238-6290
  Butte
 St. James Healthcare Cancer Care
 Benjamin Marchello, MD
Ph: 406-238-6290
  Great Falls
 Benjamin Marchello, MD
Ph: 406-238-6290
 Big Sky Oncology
 Clinical Trail Office - Big Sky Oncology
Ph: 406-731-8217
 Great Falls Clinic - Main Facility
 Benjamin Marchello, MD
Ph: 406-238-6290
 Sletten Cancer Institute at Benefis Healthcare
 Grant Harrer, MD, FACP, CCTI
Ph: 406-731-8100
  Havre
 Northern Montana Hospital
 Benjamin Marchello, MD
Ph: 406-238-6290
  Kalispell
 Glacier Oncology, PLLC
 Benjamin Marchello, MD
Ph: 406-238-6290
 Kalispell Medical Oncology at KRMC
 Benjamin Marchello, MD
Ph: 406-238-6290
 Kalispell Regional Medical Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Missoula
 Community Medical Center
 Benjamin Marchello, MD
Ph: 406-238-6290
 Guardian Oncology and Center for Wellness
 Benjamin Marchello, MD
Ph: 406-238-6290
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Ph: 406-329-7029
 Montana Cancer Specialists at Montana Cancer Center
 Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center
Ph: 406-238-6962
Nebraska
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center
Ph: 402-398-6060
 CCOP - Missouri Valley Cancer Consortium
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
 Creighton University Medical Center
 Clinical Trials Office - Creighton University Medical Center
Ph: 402-280-4100
 Immanuel Medical Center
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
 Methodist Estabrook Cancer Center
 Robert Langdon, MD
Ph: 402-399-8762
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Ph: 800-999-5465
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Ellerton, MD, CM
Ph: 702-384-0013
 University Medical Center of Southern Nevada
 John Ellerton, MD, CM
Ph: 702-384-0013
New Hampshire
  Concord
 New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
 Frederick Briccetti, MD
Ph: 603-224-2556
  Hooksett
 New Hampshire Oncology - Hematology, PA - Hooksett
 Frederick Briccetti, MD
Ph: 603-224-2556
New Jersey
  Somerville
 Somerset Medical Center
 Clinical Trials Office - Somerset Medical Center
Ph: 908-685-2481
  Sparta
 Frederick R. and Betty M. Smith Cancer Treatment Center
 Edouard Trabulsi
Ph: 973-726-4180
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees
Ph: 856-325-6757
New Mexico
  Albuquerque
 Hematology Oncology Associates, PC
 Ian Rabinowitz, MD
Ph: 505-272-4551
 Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
 Ian Rabinowitz, MD
Ph: 505-272-4551
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
New York
  Buffalo
 Roswell Park Cancer Institute
 Clinical Trials Office - Roswell Park Cancer Institute
Ph: 877-275-7724
  Manhasset
 CCOP - North Shore University Hospital
 Bhoomi Mehrotra, MD
Ph: 718-470-8934
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital
Ph: 516-734-8900
  New York
 Memorial Sloan-Kettering Cancer Center
 James Eastham, MD
Ph: 646-422-4390
 NYU Cancer Institute at New York University Medical Center
 Anna Ferrari, MD
Ph: 212-731-5389
 Ralph Lauren Center for Cancer Care and Prevention
 James Eastham, MD
Ph: 646-422-4390
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Richard Fisher, MD
Ph: 585-275-0842
  Syracuse
 SUNY Upstate Medical University Hospital
 Clinical Trials Office - SUNY Upstate Medical University Hospital
Ph: 315-464-5476
 Veterans Affairs Medical Center - Syracuse
 Leslie Howard, MD
Ph: 315-425-3456
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center
Ph: 704-355-2884
 Presbyterian Cancer Center at Presbyterian Hospital
 Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital
Ph: 704-384-5369
  Durham
 Duke Comprehensive Cancer Center
 Clinical Trials Office - Duke Comprehensive Cancer Center
Ph: 888-275-3853
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James Atkins, MD
Ph: 919-580-0000
  Kinston
 Kinston Medical Specialists
 Peter Watson, MD
Ph: 252-559-2200ext.201
  Winston-Salem
 Forsyth Regional Cancer Center at Forsyth Medical Center
 Clinical Trials Office - Forsyth Regional Cancer Center at Forsyth Medical Center
Ph: 336-277-8887
 Wake Forest University Comprehensive Cancer Center
 Clinical Trials Office - Wake Forest University Comprehensive Cancer Center
Ph: 336-713-6771
Ohio
  Columbus
 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
 Ohio State University Cancer Clinical Trial Matching Service
Ph: 866-627-7616
 Email: osu@emergingmed.com
  Dayton
 CCOP - Dayton
 Howard Gross, MD
Ph: 937-832-1093
 David L. Rike Cancer Center at Miami Valley Hospital
 Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital
Ph: 937-208-2079
 Good Samaritan Hospital
 Howard Gross, MD
Ph: 937-832-1093
 Grandview Hospital
 Howard Gross, MD
Ph: 937-832-1093
 Samaritan North Cancer Care Center
 Howard Gross, MD
Ph: 937-832-1093
  Findlay
 Blanchard Valley Medical Associates
 Howard Gross, MD
Ph: 937-832-1093
  Franklin
 Middletown Regional Hospital
 Howard Gross, MD
Ph: 937-832-1093
  Greenville
 Wayne Hospital
 Howard Gross, MD
Ph: 937-832-1093
  Kettering
 Charles F. Kettering Memorial Hospital
 Clinical Trials Office - Charles F. Kettering Memorial Hospital
Ph: 937-298-3399 ext. 57556
  Lima
 St. Rita's Medical Center
 Clinical Trials Office - St. Rita's Medical Center
Ph: 419-226-9617
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center
Ph: 937-440-4842
  Wilmington
 Clinton Memorial Hospital
 Howard Gross, MD
Ph: 937-832-1093
  Xenia
 Ruth G. McMillan Cancer Center at Greene Memorial Hospital
 Howard Gross, MD
Ph: 937-832-1093
Oregon
  Coos Bay
 Bay Area Hospital
 Bret Cook, MD
Ph: 541-267-5151
  Klamath Falls
 Sky Lakes Medical Center
 Tzann-Tarn Fang, MD
Ph: 904-549-3072
  Portland
 Kaiser Permanente Health Care - Portland
 Nagendra Tirumali, MD
Ph: 503-331-6500
Pennsylvania
  Philadelphia
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Ph: 215-955-6084
  Pittsburgh
 UPMC Cancer Centers
 Clinical Trials Office - UPMC Cancer Centers
Ph: 412-647-8073
South Carolina
  Charleston
 Roper St. Francis Cancer Center at Roper Hospital
 James Orcutt, MD
Ph: 843-577-2276
  Greenville
 CCOP - Greenville
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
Tennessee
  Kingsport
 Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
 Clinical Trials Office - Christine LaGuardia Phillips Cancer Center
Ph: 423-224-5593
  Nashville
 MBCCOP - Meharry Medical College - Nashville
 Steven Wolff, MD
Ph: 615-327-6277
 Nashville Oncology Associates, PC
 Steven Wolff, MD
Ph: 615-327-6277
 Vanderbilt-Ingram Cancer Center
 Clinical Trials Office - Vanderbilt-Ingram Cancer Center
Ph: 1-800-811-8480;
Texas
  Austin
 Southwest Regional Cancer Center - Central
 Clinical Trials Office - Southwest Regional Cancer Center - Central
Ph: 512-421-4163
 Texas Oncology, PA at South Austin Cancer Center
 Beth Hellerstedt
Ph: 512-447-2202
 Texas Oncology, PA at Texas Oncology Cancer Center - Central
 Beth Hellerstedt
Ph: 512-302-1771
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas
Ph: 713-792-3245
  Round Rock
 Texas Oncology, PA at Texas Cancer Center Round Rock
 Beth Hellerstedt
Ph: 512-341-8724
Vermont
  Berlin
 Mountainview Medical
 Steven Ades
Ph: 802-223-6196
  Burlington
 Fletcher Allen Health Care - University Health Center Campus
 Clinical Trials Office - Fletcher Allen Health Care
Ph: 802-656-8990
Virginia
  Danville
 Danville Regional Medical Center
 Clinical Trials Office - Danville Regional Medical Center
Ph: 434-799-3753
  Norton
 Southwest Virginia Regional Cancer Center at Wellmonth Health
 Malcolm Mathews, MD
Ph: 423-224-3150
Washington
  Auburn
 Auburn Regional Center for Cancer Care
 Lauren Colman, MD
Ph: 253-403-1677
  Bellingham
 St. Joseph Cancer Center
 Saul Rivkin, MD
Ph: 206-386-2441
  Bremerton
 Olympic Hematology and Oncology
 Saul Rivkin, MD
Ph: 206-386-2441
  Centralia
 Providence Centralia Hospital
 Clinical Trials Office - Providence Centralia Hospital
Ph: 360-493-4300
  Federal Way
 St. Francis Hospital
 Lauren Colman, MD
Ph: 253-403-1677
  Kennewick
 Columbia Basin Hematology
 Saul Rivkin, MD
Ph: 206-386-2441
  Olympia
 Providence St. Peter Hospital Regional Cancer Center
 Lauren Colman, MD
Ph: 253-403-1677
  Puyallup
 Good Samaritan Cancer Center
 Lauren Colman, MD
Ph: 253-403-1677
  Seattle
 Group Health Central Hospital
 Clinical Trials Office - Group Health Central Hospital
Ph: 206-287-2900
 Minor and James Medical, PLLC
 Saul Rivkin, MD
Ph: 206-386-2441
 Polyclinic First Hill
 Saul Rivkin, MD
Ph: 206-386-2441
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Saul Rivkin, MD
Ph: 206-386-2441
 University Cancer Center at University of Washington Medical Center
 Clinical Trials Office - University Cancer Center at University of Washington Medical Center
Ph: 206-616-8289
  Spokane
 Cancer Care Northwest - Spokane South
 Clinical Trials Office - Cancer Care Northwest - Spokane South
Ph: 509-228-1083
 Rockwood Clinic Cancer Treatment Center
 Clinical Trials Office - Rockwood Clinic Cancer Treatment Center
Ph: 509-838-2531 ext. 6880
  Tacoma
 Allenmore Hospital
 Lauren Colman, MD
Ph: 253-403-1677
 CCOP - Northwest
 Lauren Colman, MD
Ph: 253-403-1677
 Franciscan Cancer Center at St. Joseph Medical Center
 Clinical Trials Office - Franciscan Cancer Center
Ph: 253-426-6914
 MultiCare Regional Cancer Center at Tacoma General Hospital
 Clinical Trials Office - MultiCare Regional Cancer Center
Ph: 253-403-3229
 St. Clare Hospital
 Lauren Colman, MD
Ph: 253-403-1677
Wisconsin
  Green Bay
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Clinical Trials Office - Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Ph: 414-649-5717
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Clinical Trials Office - Regional Cancer Center at Oconomowoc Memorial Hospital
Ph: 262-928-7878
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Clinical Trials Office - Waukesha Memorial Hospital Regional Cancer Center
Ph: 262-928-7632
Canada
Alberta
  Calgary
 Tom Baker Cancer Centre - Calgary
 Bernie (Bernhard) Eigl
Ph: 403-521-3701
British Columbia
  Vancouver
 University of British Columbia
 Martin Gleave, MD
Ph: 604-875-5003
Manitoba
  Winnipeg
 CancerCare Manitoba
 Darrel Drachenberg
Ph: 204-787-2241
Ontario
  Oshawa
 R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
 Pawel Zalewski
Ph: 905-576-8711
  Toronto
 Princess Margaret Hospital
 Alexandre Zlotta
Ph: 416-946-2811

Related Information

Featured trial article

Registry Information
Official Title Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer
Trial Start Date 2006-12-15
Trial Completion Date 2011-09-10 (estimated)
Registered in ClinicalTrials.gov NCT00430183
Date Submitted to PDQ 2006-12-11
Information Last Verified 2009-07-03
NCI Grant/Contract Number CA31946

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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