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Clinical Trials (PDQ®)

  • First Published: 1/25/2007
  • Last Modified: 2/8/2012

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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 pelvic lymph nodes > 1.5 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 > 1.5 cm
        • If > 1 lymph node is > 1.5 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 ≤ 4 months allowed
  • Concurrent systemic anticoagulation allowed
  • No other concurrent systemic therapy, including androgen-deprivation therapy for the treatment of the prostate cancer
  • 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 (measured from the date of starting docetaxel). 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
  Fairbanks
 Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
 Craig Nichols, MD
Ph: 503-494-6346
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
  Burlingame
 Peninsula Medical Center
 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
  Novato
 Sutter Health - Western Division Cancer Research Group
 David Irwin, MD
Ph: 510-204-1591
  Sacramento
 University of California Davis Cancer Center
 Clinical Trials Office - University of California Davis Cancer Center
Ph: 916-734-3089
  Saint Helena
 Saint Helena Hospital
 Gregory Smith
Ph: 707-963-3611
  San Diego
 Naval Medical Center - San Diego
 Preston Gable, MD, FACP
Ph: 619-532-7319
  San Francisco
 California Pacific Medical Center - California Campus
 David Irwin, MD
Ph: 510-204-1591
  Truckee
 Tahoe Forest Cancer Center
 Primo Lara, MD
Ph: 916-734-3771
  Vallejo
 Sutter Solano Medical Center
 David Irwin, MD
Ph: 510-204-1591
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip Stella, MD
Ph: 734-712-1000
  Norwich
 Eastern Connecticut Hematology and Oncology Associates
 Dennis Slater, MD
Ph: 860-886-8362
  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: 302-623-4450
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
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Michael Schwartz, 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
  Tampa
 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
 Clinical Trials Office - H. Lee Moffitt Cancer Center and Reseach Institute
Ph: 800-456-7121
  Email: canceranswers@moffitt.org
  Weston
 Cleveland Clinic Florida - Weston
 Clinical Trials Office - Cleveland Clinic Florida - Weston
Ph: 954-659-5705
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey Berenberg, MD
Ph: 808-433-4089
  Honolulu
 Cancer Research Center of Hawaii
 Clinical Trials Office - Cancer Research Center of Hawaii
Ph: 808-586-2979
 Hawaii Medical Center - East
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Kapiolani Medical Center for Women and Children
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Straub Clinic and Hospital, Incorporated
 Jeffrey Berenberg, MD
Ph: 808-433-4089
  Kailua
 Castle Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
  Lihue
 Kauai Medical Clinic
 Jeffrey Berenberg, MD
Ph: 808-433-4089
  Wailuku
 Maui Memorial Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Pacific Cancer Institute - Maui
 Jeffrey Berenberg, MD
Ph: 808-433-4089
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Clinical Trials Office - Saint Alphonsus Cancer Care Center
Ph: 208-367-7954
Illinois
  Chicago
 Louis A. Weiss Memorial Hospital
 Clinical Trials Office - Louis A. Weiss Memorial Hospital
Ph: 773- 564-5044
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
  Hines
 Veterans Affairs Medical Center - Hines
 Nirmala Bhoopalam, MD
Ph: 708-202-2782
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Clinical Trials Office - Cardinal Bernardin Cancer Center
Ph: 708-226-4357
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Elkhart General Hospital
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - Elkhart
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  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
  Mishawaka
 Michiana Hematology-Oncology, PC - South Bend
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Saint Joseph Regional Medical Center
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  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
 Michiana Hematology-Oncology, PC - South Bend
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Westville
 Michiana Hematology Oncology PC - La Porte
 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 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
Kansas
  Hays
 Hays Medical Center
 Peter VanVeldhuizen, MD
Ph: 816-861-4700ext.56775
  Hutchinson
 Hutchinson Hospital Corporation
 Peter VanVeldhuizen, MD
Ph: 816-861-4700ext.56775
  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
  Pittsburg
 Mount Carmel Regional Cancer Center
 Peter VanVeldhuizen, MD
Ph: 816-861-4700ext.56775
  Salina
 Tammy Walker Cancer Center at Salina Regional Health Center
 Peter VanVeldhuizen, MD
Ph: 816-861-4700ext.56775
  Topeka
 St. Francis Comprehensive Cancer Center
 Peter VanVeldhuizen, MD
Ph: 816-861-4700ext.56775
Louisiana
  Alexandria
 Tulane Cancer Center Office of Clinical Research
 Clinical Trials Office - Tulane Cancer Center
Ph: 504-988-6121
  Baton Rouge
 Mary Bird Perkins Cancer Center - Baton Rouge
 Robert Veith
Ph: 225-767-0847
  New Orleans
 MBCCOP - LSU Health Sciences Center
 Robert Veith
Ph: 504-568-5151
 Medical Center of Louisiana - New Orleans
 Robert Veith
Ph: 504-903-2311
Maine
  Scarborough
 Maine Center for Cancer Medicine and Blood Disorders - Scarborough
 Frederick Aronson, MD
Ph: 207-885-7600
Maryland
  Elkton MD
 Union Hospital of Cecil County
 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
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip Stella, MD
Ph: 734-712-1000
 Saint Joseph Mercy Cancer Center
 Philip Stella, MD
Ph: 734-712-1000
  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
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center
Ph: 313-593-8090
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Robert Chapman, MD
Ph: 313-916-1332
  Flint
 Genesys Hurley Cancer Institute
 Clinical Trials Office - Genesys Hurley Cancer Institute
Ph: 810-762-8057
 Hurley Medical Center
 Clinical Trials Office - Hurley Medical Center
Ph: 810-762-8057
  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
  Grosse Pointe Woods
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center
Ph: 313-343-3166
  Jackson
 Foote Memorial Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Lansing
 Sparrow Regional Cancer Center
 Clinical Trials Office - Sparrow Regional Cancer Center
Ph: 517-364-2890
  Livonia
 St. Mary Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Muskegon
 Mercy General Health Partners
 Martin Bury
Ph: 231-672-2000
  Niles
 Michiana Hematology Oncology PC - Niles
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Pontiac
 St. Joseph Mercy Oakland
 Philip Stella, MD
Ph: 734-712-1000
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Clinical Trials Office - Seton Cancer Institute - Saginaw
Ph: 989-776-8411
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  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
  Warren
 St. John Macomb Hospital
 Philip Stella, MD
Ph: 734-712-1000
Minnesota
  Alexandria
 Donald Jurgens
  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
 Patrick Flynn, MD
Ph: 612-863-8585
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
 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
 Masonic Cancer Center at University of Minnesota
 Clinical Trials Office - Masonic Cancer Center at University of Minnesota
Ph: 612-624-2620
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Saint Cloud
 CentraCare Clinic - River Campus
 Donald Jurgens
Ph: 320-252-5131
 Coborn Cancer Center
 Donald Jurgens
Ph: 320-229-4907
877-229-4907
  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
  Stillwater
 Lakeview Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Waconia
 Ridgeview Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Patrick Flynn, MD
Ph: 612-863-8585
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Charles Pound, MD
Ph: 601-984-5185
Missouri
  Kansas City
 Truman Medical Center - Hospital Hill
 Peter VanVeldhuizen, MD
Ph: 816-861-4700ext.56775
  Saint Louis
 Saint Louis University Cancer Center
 Clinical Trials Office - Saint Louis University Cancer Center
Ph: 314-977-4440
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
 St. Vincent Healthcare Cancer Care Services
 Benjamin Marchello, MD
Ph: 406-238-6290
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Butte
 St. James Healthcare Cancer Care
 Benjamin Marchello, MD
Ph: 406-238-6290
  Great Falls
 Big Sky Oncology
 Clinical Trial 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
  Helena
 St. Peter's 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
 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
Nebraska
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
  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
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
 Douglas Weckstein, MD
Ph: 603-622-6484
  Exeter
 Center for Cancer Care at Exeter Hospital
 Michael Buff
Ph: 603-580-6636
  Hooksett
 New Hampshire Oncology - Hematology, PA - Hooksett
 Douglas Weckstein, MD
Ph: 603-622-6484
New Jersey
  Marlton
 Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
 Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Ph: 888-847-8823
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Stacey Leibowitz
Ph: 973-971-6100
800-247-9580
  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
  Summit
 Overlook Hospital
 Stacey Leibowitz
Ph: 908-522-2000
  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
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Michael Entmacher, MD
Ph: 609-702-1900
New Mexico
  Albuquerque
 Hematology Oncology Associates, PC
 Richard Lauer
Ph: 505-938-5858
 Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
 Richard Lauer
Ph: 505-291-2462
 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
  New York
 Memorial Sloan-Kettering Cancer Center
 James Eastham, MD
Ph: 646-422-4390
 New York Weill Cornell Cancer Center at Cornell University
 Clinical Trials Office - New York Weill Cornell Cancer Center at Cornell University
Ph: 212-746-1848
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan Friedberg
Ph: 585-275-5345
  Syracuse
 SUNY Upstate Medical University Hospital
 Clinical Trials Office - SUNY Upstate Medical University Hospital
Ph: 315-464-5476
 Veterans Affairs Medical Center - Syracuse
 Ajeet Gajra, MD
Ph: 315-425-4666
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 Cancer Institute
 Clinical Trials Office - Duke Cancer Institute
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
  Rutherfordton
 Rutherford Hospital
 Charles Bowers
Ph: 828-286-5000
  Statesville
 Iredell Memorial Hospital
 Ruby Grimm, MD
Ph: 704-873-2219
  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 Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Ohio State University Cancer Clinical Trial Matching Service
Ph: 866-627-7616
  Email: osu@emergingmed.com
  Lima
 St. Rita's Medical Center
 Clinical Trials Office - St. Rita's Medical Center
Ph: 419-226-9617
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Shubham Pant
Ph: 405-271-6822
Oregon
  Coos Bay
 Bay Area Hospital
 Bret Cook, MD
Ph: 541-267-5151
  Portland
 Kaiser Permanente Health Care - Portland
 Nagendra Tirumali, MD
Ph: 503-331-6500
Pennsylvania
  Darby
 Mercy Fitzgerald Hospital
 Clinical Trials Office - Mercy Fitzgerald Hospital
Ph: 610-237-4982
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Clinical Trials Office - Fox Chase Cancer Center - Philadelphia
Ph: 215-728-4790
 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
  Anderson
 AnMed Cancer Center
 Clinical Trials Office - AnMed Cancer Center
Ph: 864-512-1000
  Charleston
 Roper St. Francis Cancer Center at Roper Hospital
 James Orcutt, MD
Ph: 843-577-2276
  Greenville
 Bon Secours St. Francis Health System
 Clinical Trails Office - Bon Secours St. Francis Health System
Ph: 864-255-1713
 CCOP - Greenville
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
  Spartanburg
 CCOP - Upstate Carolina
 Clinical Trials Office - CCOP - Upstate Carolina
Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Clinical Trials Office - Gibbs Regional Cancer Center
Ph: 800-486-5941
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
Texas
  Austin
 Southwest Regional Cancer Center - Central
 Clinical Trials Office - Southwest Regional Cancer Center - Central
Ph: 512-421-4163
 Texas Oncology, PA - Austin North
 Beth Hellerstedt
Ph: 512-873-8900
 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
  Cedar Park
 Texas Oncology, PA - Cedar Park
 Beth Hellerstedt
Ph: 512-260-6050
  Round Rock
 Texas Oncology, PA - Seton Williamson
 Beth Hellerstedt
Ph: 512-687-2300
 Texas Oncology, PA at Texas Cancer Center Round Rock
 Beth Hellerstedt
Ph: 512-341-8724
  San Marcos
 Texas Oncology, PA - San Marcos
 Beth Hellerstedt
Ph: 512-396-5199
888-340-9753
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
  Lynchburg
 Lynchburg Hematology-Oncology Clinic
 John Leach MacNeill, MD
Ph: 434-947-5925
  Norton
 Southwest Virginia Regional Cancer Center at Wellmonth Health
 Asheesh Shipstone
Ph: 540-679-5874
Washington
  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
  Kirkland
 Cascade Cancer Center at Evergreen Hospital Medical Center
 Craig Nichols, MD
Ph: 503-494-6346
  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
 CCOP - Virginia Mason Research Center
 Craig Nichols, MD
Ph: 503-494-6346
 Pacific Medical Center
 Craig Nichols, MD
Ph: 503-494-6346
 Virginia Mason Medical Center
 Craig Nichols, MD
Ph: 503-494-6346
  Spokane
 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
 Madigan Army Medical Center - Tacoma
 Anthony Fadell
Ph: 206-968-1110
 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
West Virginia
  Huntington
 Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
 Oncology Research Supervisor
Ph: 304-399-6617
Wyoming
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Marchello, MD
Ph: 406-238-6290
Canada
Alberta
  Calgary
 Tom Baker Cancer Centre - Calgary
 Joseph Ruether
Ph: 403-521-3723
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
  London
 London Regional Cancer Program at London Health Sciences Centre
 Joseph Chin
Ph: 519-685-8615
  Toronto
 Princess Margaret Hospital
 Alexandre Zlotta
Ph: 416-946-2811
Quebec
  Montreal
 Hopital Notre-Dame du CHUM
 Fred Saad, MD, FRCS
Ph: 514-890-8000ext27466

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 2012-02-08
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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