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

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI CALGB-90203 CALGB-90203, NCT00430183

Special Category: CTSU 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

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

Outcomes

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

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

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:  510-204-2866
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Fullerton
	Virginia K. Crosson Cancer Center at St. Jude Medical Center
		Clinical Trials Office - Virginia K. Crosson Cancer Center	Ph:  714-446-5642
	Greenbrae
	Marin Cancer Institute at Marin General Hospital
		David Irwin, MD	Ph:  510-204-2866
	Sutter Health - Western Division Cancer Research Group
		David Irwin, MD	Ph:  510-204-2866
	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:  510-204-2866
	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:  510-204-2866
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		Clinical Trials Office - University of Colorado Cancer Center	Ph:  720-848-0650
	Denver
	Denver Health Medical Center
		Thomas Flaig	Ph:  303-436-6000
	Veterans Affairs Medical Center - Denver
		Thomas Flaig	Ph:  303-399-8020 888-336-8262
	Edwards
	Shaw Regional Cancer Center
		Thomas Flaig	Ph:  970-569-7429
	Fort Collins
	Front Range Cancer Specialists
		Diana Medgyesy, MD	Ph:  970-212-7600
	Poudre Valley Hospital
		Clinical Trials Office - Poudre Valley Hospital	Ph:  970-495-8226
	Montrose
	Montrose Memorial Hospital Cancer Center
		Clinical Trials Office - Montrose Memorial Hospital Cancer Center	Ph:  670-240-7267
Connecticut
	Hartford
	Helen and Harry Gray Cancer Center at Hartford Hospital
		Clinical Trials Office - Helen and Harry Gray Cancer Center	Ph:  860-545-5363
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph:  203-785-5702
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
	George Washington University Medical Center
		Clinical Trials Office - George Washington University Medical Center	Ph:  202-741-2981
	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
	Leesburg
	Cancer Centers of Central Florida, PA
		Donald Elmajian, MD	Ph:  318-813-1440
	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
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Aurora
	Rush-Copley Cancer Care Center
		Kendrith Rowland, MD	Ph:  217-383-3010
	Bloomington
	St. Joseph Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3000
	Carthage
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3000
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3000
	Evanston
	Evanston Northwestern Healthcare - Evanston Hospital
		Clinical Trials Office - Evanston Northwestern Healthcare - Evanston Hospital	Ph:  847-570-1381
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3000
	Galesburg Cottage Hospital
		John Kugler, MD	Ph:  309-243-3000
	Havana
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3000
	Hopedale
	Hopedale Medical Complex
		John Kugler, MD	Ph:  309-243-3000
	Joliet
	Joliet Oncology-Hematology Associates, Limited - West
		Kendrith Rowland, MD	Ph:  217-383-3010
	Macomb
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3000
	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:  314-251-6573
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3000
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3000
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3000
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3000
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3000
	OSF St. Francis Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3000
	Peru
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3000
	Princeton
	Perry Memorial Hospital
		John Kugler, MD	Ph:  309-243-3000
	Spring Valley
	St. Margaret's Hospital
		John Kugler, MD	Ph:  309-243-3000
	Urbana
	Carle Cancer Center at Carle Foundation Hospital
		Clinical Trials Office - Carle Cancer Center	Ph:  800-446-5532
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  317-787-3311
	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
	Michigan City
	Saint Anthony Memorial Health Centers
		Kendrith Rowland, MD	Ph:  217-383-3010
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  765-983-3000
	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
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
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
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:  318-213-0380
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:  410-398-4000
	Salisbury
	Peninsula Regional Medical Center
		Clinical Trials Office - Peninsula Regional Medical Center	Ph:  410-543-7000
Massachusetts
	Burlington
	Lahey Clinic Medical Center - Burlington
		Clinical Trials Office - Lahey Clinic Medical Center - Burlington	Ph:  781-744-8027
	Pittsfield
	Berkshire Hematology Oncology, PC
		Harvey Zimbler, MD	Ph:  413-443-6000
Michigan
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Minnesota
	Alexandria
		Harold Windschitl, MD	Ph:  320-762-8903 800-835-6624
	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
	Fergus Falls
		Harold Windschitl, MD	Ph:  218-739-6654
		Harold Windschitl, MD	Ph:  800-237-1225
	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
	Saint Cloud
	CentraCare Clinic - River Campus
		Harold Windschitl, MD	Ph:  320-252-5131
	Coborn Cancer Center
		Harold Windschitl, MD	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
	HealthEast Cancer Care at St. Joseph's Hospital
		Daniel Anderson	Ph:  651-232-7970
	United Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Daniel Anderson	Ph:  952-403-2031
	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
	HealthEast Cancer Care at Woodwinds Health Campus
		Daniel Anderson	Ph:  651-232-7970
	Minnesota Oncology Hematology, PA - Woodbury
		Patrick Flynn, MD	Ph:  612-863-8585
Missouri
	Cape Girardeau
	Saint Francis Medical Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Chesterfield
	Saint Luke's Hospital
		Donald Busiek, MD	Ph:  314-205-6737
	Gape Girardeau
	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
		Bethany Sleckman, MD	Ph:  314-251-6573
	Saint Louis
	CCOP - St. Louis-Cape Girardeau
		Bethany Sleckman, MD	Ph:  314-251-6573
	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:  314-251-6573
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Joel Picus, MD	Ph:  314-747-1367
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:  406-259-2245 800-361-3239
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290 800-648-6274
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-248-2212 800-358-8818
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-657-7000
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-585-5070
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-723-2500
	Great Falls
		Benjamin Marchello, MD
	Big Sky Oncology
		Clinical Trail Office - Big Sky Oncology	Ph:  406-731-8217
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-454-2171 800-421-1649
	Sletten Cancer Institute at Benefis Healthcare
		Grant Harrer, MD, FACP, CCTI	Ph:  406-455-2820
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-442-2480
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-752-7600
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-752-8900
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-752-5111
	Missoula
	Community Medical Center
		Benjamin Marchello, MD	Ph:  406-728-4100
	Guardian Oncology and Center for Wellness
		Benjamin Marchello, MD	Ph:  406-721-1118
	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:  402-354-5890 877-850-3212
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:  702-383-2000
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:  603-622-6484 800-339-6484
New Jersey
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Stacey Leibowitz	Ph:  973-971-6100 800-247-9580
	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
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:  718-470-8930
	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 Hyde Park
	Long Island Jewish Medical Center
		Bhoomi Mehrotra, MD	Ph:  718-470-8930
	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
		Richard Fisher, MD	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
		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:  252-559-2200 ext. 201
	Rutherfordton
	Rutherford Hospital
		James Bearden, MD	Ph:  864-560-6812
	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
		Clinical Trials Office - OSU Comprehensive Cancer Center	Ph:  614-293-4976
			Email: osu@emergingmed.com
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-395-8678
	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:  937-278-2612
	Grandview Hospital
		Howard Gross, MD	Ph:  937-226-3200
	Samaritan North Cancer Care Center
		Howard Gross, MD	Ph:  937-279-5800 800-616-6784
	Veterans Affairs Medical Center - Dayton
		Howard Gross, MD	Ph:  937-268-6511
	Findlay
	Blanchard Valley Medical Associates
		Howard Gross, MD	Ph:  419-424-0380
	Franklin
	Middletown Regional Hospital
		Howard Gross, MD	Ph:  513-424-2111
	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:  937-382-6611
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard Gross, MD	Ph:  937-352-2140
Oregon
	Coos Bay
	Bay Area Hospital
		Bret Cook, MD	Ph:  541-269-8111
Pennsylvania
	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
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-241-6251
	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
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Richard Tenglin	Ph:  605-719-2360
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
	Texas Oncology - Midtown Austin
		Beth Hellerstedt	Ph:  512-478-9990
	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
	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
	Bellingham
	St. Joseph Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2929
	Bremerton
	Olympic Hematology and Oncology
		Saul Rivkin, MD	Ph:  206-386-2929
	Kennewick
	Columbia Basin Hematology
		Saul Rivkin, MD	Ph:  206-386-2929
	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:  206-386-2929
	Polyclinic First Hill
		Saul Rivkin, MD	Ph:  206-386-2929
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Saul Rivkin, MD	Ph:  206-386-2929
	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
West Virginia
	Huntington
	Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
		Oncology Research Supervisor	Ph:  304-399-6617
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
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  307-674-6022
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

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		2008-09-19
NCI Grant/Contract Number		CA31946

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