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Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: January 30, 2007   Last Updated: November 20, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00430183
  Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.


Condition Intervention Phase
Prostate Cancer
 Drug: docetaxel
Drug: goserelin
Drug: leuprolide acetate
Procedure: conventional surgery
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Surgery
Drug Information available for: Leuprolide Goserelin Leuprolide acetate Docetaxel
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 3-year biochemical progression-free survival (bPFS) rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 5-year bPFS rate and bPFS [ Designated as safety issue: No ]
  • Time to clinical local recurrence [ Designated as safety issue: No ]
  • Time to metastatic disease progression [ Designated as safety issue: No ]
  • Unacceptable toxicity [ Designated as safety issue: Yes ]
  • Prostate cancer-specific-free survival [ Designated as safety issue: No ]
  • Disease progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Death [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: December 2006
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
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.
Drug: docetaxel
Given IV over 1 hour
Drug: goserelin
Given subcutaneously
Drug: leuprolide acetate
Given intramuscularly
Procedure: conventional surgery
Patients undergo radical prostatectomy with staging pelvic lymphadenectomy
Arm II: Active Comparator
Within 60 days after randomization, patients undergo radical prostatectomy with staging pelvic lymphadenectomy.
Procedure: conventional surgery
Patients undergo radical prostatectomy with staging pelvic lymphadenectomy

Detailed Description:

OBJECTIVES:

Primary

  • 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

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

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 10 years
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 150,000/mm^3
  • 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430183

  Hide Study Locations
Locations
United States, Alaska
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital Recruiting
Fairbanks, Alaska, United States, 99701
Contact: Jacqueline Vuky     907-458-5380        
Providence Cancer Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Clinical Trials Office - Providence Cancer Center     907-261-3109        
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni     501-686-8274        
United States, California
Alta Bates Summit Comprehensive Cancer Center Recruiting
Berkeley, California, United States, 94704
Contact: Clinical Trials Office - Alta Bates Summit Comprehensive Cance     510-204-3428        
California Pacific Medical Center - California Campus Recruiting
San Francisco, California, United States, 94118
Contact: David H. Irwin, MD     510-204-1591        
Sutter Solano Medical Center Recruiting
Vallejo, California, United States, 94589
Contact: David H. Irwin, MD     510-204-1591        
Marin Cancer Institute at Marin General Hospital Recruiting
Greenbrae, California, United States, 94904
Contact: David H. Irwin, MD     510-204-1591        
Peninsula Medical Center Recruiting
Burlingame, California, United States, 94010
Contact: David H. Irwin, MD     510-204-1591        
Providence Saint Joseph Medical Center - Burbank Recruiting
Burbank, California, United States, 91505
Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente     818-847-3220        
Rebecca and John Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093-0658
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer     858-822-5354     cancercto@ucsd.edu    
Sutter Health - Western Division Cancer Research Group Recruiting
Greenbrae, California, United States, 94904
Contact: David H. Irwin, MD     510-204-1591        
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen     800-826-4673     becomingapatient@coh.org    
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi     877-827-3222        
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer     916-734-3089        
USC/Norris Comprehensive Cancer Center and Hospital Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente     323-865-0451        
Veterans Affairs Medical Center - San Diego Recruiting
San Diego, California, United States, 92161
Contact: Barbara A. Parker     858-552-8585        
Virginia K. Crosson Cancer Center at St. Jude Medical Center Recruiting
Fullerton, California, United States, 92835
Contact: Clinical Trials Office - Virginia K. Crosson Cancer Center     714-446-5642        
United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Contact: Thomas W. Flaig     303-436-6000        
Montrose Memorial Hospital Cancer Center Recruiting
Montrose, Colorado, United States, 81401
Contact: Clinical Trials Office - Montrose Memorial Hospital Cancer Cen     670-240-7267        
Shaw Regional Cancer Center Recruiting
Edwards, Colorado, United States, 81632
Contact: Thomas W. Flaig     970-569-7429        
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center     720-848-0650        
Veterans Affairs Medical Center - Denver Recruiting
Denver, Colorado, United States, 80220
Contact: Thomas W. Flaig     303-399-8020        
United States, Connecticut
Veterans Affairs Medical Center - West Haven Recruiting
West Haven, Connecticut, United States, 06516
Contact: Edward M. Uchio     203-937-3421        
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services     302-733-6227        
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center     302-645-3171        
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center     202-444-0381        
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307-5001
Contact: Clinical Trials Office - Walter Reed Army Medical Center     202-782-7840        
United States, Florida
Cancer Centers of Central Florida, PA Recruiting
Leesburg, Florida, United States, 34788
Contact: Donald A. Elmajian, MD     318-813-1200        
CCOP - Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Rogerio C. Lilenbaum, MD     305-535-3310        
Cleveland Clinic Florida - Weston Recruiting
Weston, Florida, United States, 33331
Contact: Clinical Trials Office - Cleveland Clinic Florida - Weston     954-659-5705        
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Clinical Trials Office - Michael and Dianne Bienes Comprehensi     954-776-3239        
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute     407-303-5623        
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Recruiting
Jupiter, Florida, United States, 33458
Contact: Clinical Trials Office - Ella Milbank Foshay Cancer Center     561-745-5768        
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center     708-226-4357        
Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201-1781
Contact: Clinical Trials Office - Evanston Hospital     847-570-1381        
Good Samaritan Regional Health Center Recruiting
Mt. Vernon, Illinois, United States, 62864
Contact: Bethany G. Sleckman, MD     314-251-7057        
Mid-Illinois Hematology-Oncology Associates at Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: John J. Migas, MD     309-451-2207        
Saint Anthony's Hospital at Saint Anthony's Health Center Recruiting
Alton, Illinois, United States, 62002
Contact: Bethany G. Sleckman, MD     314-251-7057        
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
United States, Indiana
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Center for Cancer Therapy at LaPorte Hospital and Health Services Recruiting
La Porte, Indiana, United States, 46350
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Howard Community Hospital Recruiting
Kokomo, Indiana, United States, 46904
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend     800-284-7370        
Saint Joseph Regional Medical Center Recruiting
South Bend, Indiana, United States, 46617
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
South Bend Clinic Recruiting
South Bend, Indiana, United States, 46617
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
United States, Iowa
Genesis Medical Center - West Campus Recruiting
Davenport, Iowa, United States, 52804
Contact: George Kovach, MD     563-421-1960        
Genesis Regional Cancer Center at Genesis Medical Center Recruiting
Davenport, Iowa, United States, 52803
Contact: George Kovach, MD     563-421-1960        
Hematology Oncology Associates of the Quad Cities Recruiting
Bettendorf, Iowa, United States, 52722
Contact: Shobha R. Chitneni, MD, MBBS     563-355-7733        
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service     800-237-1225        
Veterans Affairs Medical Center - Iowa City Recruiting
Iowa City, Iowa, United States, 52246
Contact: Daniel A. Vaena     319-338-0581        
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-7357
Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit     913-588-4709        
United States, Louisiana
Feist-Weiller Cancer Center at Louisiana State University Health Sciences Recruiting
Shreveport, Louisiana, United States, 71130-3932
Contact: Clinical Trials Office - Feist-Weiller Cancer Center at Louisi     318-813-1412        
Highland Clinic Recruiting
Shreveport, Louisiana, United States, 71105
Contact: Donald A. Elmajian, MD     318-813-1200        
Mary Bird Perkins Cancer Center - Baton Rouge Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Robert W. Veith     225-767-0847        
MBCCOP - LSU Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Robert W. Veith     504-568-5151        
Medical Center of Louisiana - New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Robert W. Veith     504-903-2311        
Pennington Cancer Center at Baton Rouge General Recruiting
Baton Rouge, Louisiana, United States, 70806
Contact: Clinical Trials Office - Pennington Cancer Center at Baton Rou     225-381-6451        
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Recruiting
Scarborough, Maine, United States, 04074
Contact: Frederick R. Aronson, MD     207-885-7600        
United States, Maryland
Peninsula Regional Medical Center Recruiting
Salisbury, Maryland, United States, 21801
Contact: Clinical Trials Office - Peninsula Regional Medical Center     410-543-7000        
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce     410-955-8804     jhcccro@jhmi.edu    
Union Hospital Cancer Program at Union Hospital Recruiting
Elkton Md, Maryland, United States, 21921
Contact: Stephen S. Grubbs, MD     302-366-1200        
United States, Massachusetts
Berkshire Hematology Oncology, PC Recruiting
Pittsfield, Massachusetts, United States, 01201
Contact: Harvey Zimbler, MD     413-496-8205        
United States, Michigan
Battle Creek Health System Cancer Care Center Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Martin J. Bury     616-966-8000        
Josephine Ford Cancer Center at Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Robert A. Chapman, MD     313-916-1332        
CCOP - Grand Rapids Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Martin J. Bury     616-391-1230        
Butterworth Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Martin J. Bury     616-391-2799        
Lacks Cancer Center at Saint Mary's Health Care Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Martin J. Bury     616-752-5222        
Lakeland Regional Cancer Care Center - St. Joseph Recruiting
St. Joseph, Michigan, United States, 49085
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Mecosta County Medical Center Recruiting
Big Rapids, Michigan, United States, 49307
Contact: Martin J. Bury     231-796-8691        
Mercy General Health Partners Recruiting
Muskegon, Michigan, United States, 49443
Contact: Martin J. Bury     231-672-2000        
Metro Health Hospital Recruiting
Wyoming, Michigan, United States, 49519
Contact: Martin J. Bury     616-252-7200        
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Martin J. Bury     231-935-6202        
United States, Minnesota
Adult and Pediatric Urology, PLLP Recruiting
Sartell, Minnesota, United States, 56377
Contact: Donald J. Jurgens     320-229-4907        
HealthEast Cancer Care at St. John's Hospital Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Daniel M. Anderson     651-232-7970        
CentraCare Clinic - River Campus Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens     320-229-4907        
Coborn Cancer Center Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens     320-229-4907        
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Patrick J. Flynn, MD     612-863-8585        
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Clinical Trials Office - Fairview Southdale Hospital     612-625-3650        
CCOP - Metro-Minnesota Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD     612-863-8585        
Hennepin County Medical Center - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Clinical Trials Office - Hennepin County Medical Center - Minn     612-873-5911        
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Recruiting
Robbinsdale, Minnesota, United States, 55422-2900
Contact: Clinical Trials Office - Hubert H. Humphrey Cancer Center at N     763-520-1893        
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Daniel M. Anderson     320-234-5000        
Recruiting
Alexandria, Minnesota, United States, 56308
Contact: Donald J. Jurgens     320-229-4907        
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
Meeker County Memorial Hospital Recruiting
Lichfield, Minnesota, United States, 55355
Contact: Clinical Trials Office - Meeker County Memorial Hospital     320-693-4520        
Mercy and Unity Cancer Center at Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Patrick J. Flynn, MD     612-863-8585        
St. Francis Cancer Center at St. Francis Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Patrick J. Flynn, MD     612-863-8585        
Minnesota Oncology Hematology, PA - Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn, MD     612-863-8585        
Minnesota Oncology Hematology, PA - Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Patrick J. Flynn, MD     612-863-8585        
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD     612-863-8585        
Regions Hospital Cancer Care Center Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Clinical Trials Office - Regions Hospital Cancer Care Center     651-254-1517        
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Patrick J. Flynn, MD     612-863-8585        
Mercy and Unity Cancer Center at Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Patrick J. Flynn, MD     612-863-8585        
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Patrick J. Flynn, MD     612-863-8585        
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Clinical Trials Office - Virginia Piper Cancer Institute     612-863-5654        
United States, Missouri
CCOP - St. Louis-Cape Girardeau Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman, MD     314-251-7057        
David C. Pratt Cancer Center at St. John's Mercy Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J     314-251-6770        
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Joel Picus, MD     314-362-5737        
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Bethany G. Sleckman, MD     314-251-7057        
Midwest Hematology Oncology Group, Incorporated Recruiting
Saint Louis, Missouri, United States, 63109
Contact: Bethany G. Sleckman, MD     314-251-7057        
United States, Montana
Glacier Oncology, PLLC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown     800-996-2663     research@billingsclinic.org    
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD     406-238-6290        
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Community Medical Center Recruiting
Missoula, Montana, United States, 59801
Contact: Benjamin T. Marchello, MD     406-238-6290        
Big Sky Oncology Recruiting
Great Falls, Montana, United States, 59405-5309
Contact: Clinical Trail Office - Big Sky Oncology     406-731-8217        
Great Falls Clinic - Main Facility Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD     406-238-6290        
Guardian Oncology and Center for Wellness Recruiting
Missoula, Montana, United States, 59804
Contact: Benjamin T. Marchello, MD     406-238-6290        
Hematology-Oncology Centers of the Northern Rockies - Billings Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Kalispell Medical Oncology at KRMC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD     406-238-6290        
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Recruiting
Missoula, Montana, United States, 59807
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick     406-329-7029        
St. Vincent Healthcare Cancer Care Services Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Northern Montana Hospital Recruiting
Havre, Montana, United States, 59501
Contact: Benjamin T. Marchello, MD     406-238-6290        
Northern Rockies Radiation Oncology Center Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Sletten Cancer Institute at Benefis Healthcare Recruiting
Great Falls, Montana, United States, 59405
Contact: Grant W. Harrer, MD, FACP, CCTI     406-731-8100        
St. James Healthcare Cancer Care Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello, MD     406-238-6290        
St. Peter's Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello, MD     406-238-6290        
Montana Cancer Specialists at Montana Cancer Center Recruiting
Missoula, Montana, United States, 59807-7877
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana     406-238-6962        
United States, Nebraska
Alegant Health Cancer Center at Bergan Mercy Medical Center Recruiting
Omaha, Nebraska, United States, 68124
Contact: Clinical Trials Office - Alegant Health Cancer Center at Berge     402-398-6060        
CCOP - Missouri Valley Cancer Consortium Recruiting
Omaha, Nebraska, United States, 68106
Contact: Gamini S. Soori, MD, FACP, FRCP, MBA     402-393-3110        
Creighton University Medical Center Recruiting
Omaha, Nebraska, United States, 68131-2197
Contact: Clinical Trials Office - Creighton University Medical Center     402-280-4100        
Immanuel Medical Center Recruiting
Omaha, Nebraska, United States, 68122
Contact: Gamini S. Soori, MD, FACP, FRCP, MBA     402-393-3110        
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Robert M. Langdon, MD     402-399-8762        
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ     800-999-5465        
United States, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton, MD, CM     702-384-0013        
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John A. Ellerton, MD, CM     702-384-0013        
United States, New Hampshire
New Hampshire Oncology - Hematology, PA - Hooksett Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Frederick M. Briccetti, MD     603-224-2556        
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Recruiting
Concord, New Hampshire, United States, 03301
Contact: Frederick M. Briccetti, MD     603-224-2556        
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo     856-325-6757        
Carol G. Simon Cancer Center at Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Stacey B. Leibowitz     973-971-6100        
Frederick R. and Betty M. Smith Cancer Treatment Center Recruiting
Sparta, New Jersey, United States, 07871
Contact: Edouard J. Trabulsi     973-726-4180        
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Stacey B. Leibowitz     908-522-2000        
Somerset Medical Center Recruiting
Somerville, New Jersey, United States, 08876
Contact: Clinical Trials Office - Somerset Medical Center     908-685-2481        
United States, New Mexico
Hematology Oncology Associates, PC Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Ian Rabinowitz, MD     505-272-4551        
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital Recruiting
Albuquerque, New Mexico, United States, 87110
Contact: Ian Rabinowitz, MD     505-272-4551        
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente     505-272-6972        
United States, New York
CCOP - North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Bhoomi Mehrotra, MD     718-470-8934        
Don Monti Comprehensive Cancer Center at North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center     516-734-8900        
Veterans Affairs Medical Center - Syracuse Recruiting
Syracuse, New York, United States, 13210
Contact: Leslie M. Howard, MD     315-425-3456        
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: James A. Eastham, MD     646-422-4390        
NYU Cancer Institute at New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Anna C. Ferrari, MD     212-731-5389        
Ralph Lauren Center for Cancer Care and Prevention Recruiting
New York, New York, United States, 10035
Contact: James A. Eastham, MD     646-422-4390        
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute     877-275-7724        
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi     315-464-5476        
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Richard I. Fisher, MD     585-275-0842        
United States, North Carolina
Duke Comprehensive Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center     888-275-3853        
Forsyth Regional Cancer Center at Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Clinical Trials Office - Forsyth Regional Cancer Center at For     336-277-8887        
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD     252-559-2200ext.201        
Leo W. Jenkins Cancer Center at ECU Medical School Recruiting
Greenville, North Carolina, United States, 27834
Contact: Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M     252-744-2391        
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
Southeastern Medical Oncology Center - Goldsboro Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
Presbyterian Cancer Center at Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt     704-384-5369        
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     osu@emergingmed.com    
Clinton Memorial Hospital Recruiting
Wilmington, Ohio, United States, 45177
Contact: Howard M. Gross, MD     937-832-1093        
Samaritan North Cancer Care Center Recruiting
Dayton, Ohio, United States, 45415
Contact: Howard M. Gross, MD     937-832-1093        
St. Rita's Medical Center Recruiting
Lima, Ohio, United States, 45801
Contact: Clinical Trials Office - St. Rita's Medical Center     419-226-9617        
Wayne Hospital Recruiting
Greenville, Ohio, United States, 45331
Contact: Howard M. Gross, MD     937-832-1093        
United States, Oregon
Bay Area Hospital Recruiting
Coos Bay, Oregon, United States, 97420
Contact: Bret A. Cook, MD     541-267-5151        
Kaiser Permanente Health Care - Portland Recruiting
Portland, Oregon, United States, 97232
Contact: Nagendra Tirumali, MD     503-331-6500        
Sky Lakes Medical Center Recruiting
Klamath Falls, Oregon, United States, 97601
Contact: Tzann-Tarn Fang, MD     904-549-3072        
United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer     215-955-6084        
UPMC Cancer Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Clinical Trials Office - UPMC Cancer Centers     412-647-8073        
United States, South Carolina
CCOP - Greenville Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey K. Giguere, MD, FACP     864-987-7000        
Roper St. Francis Cancer Center at Roper Hospital Recruiting
Charleston, South Carolina, United States, 29401
Contact: James M. Orcutt, MD     843-577-2276        
United States, Tennessee
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Recruiting
Kingsport, Tennessee, United States, 37662
Contact: Clinical Trials Office - Christine LaGuardia Phillips Cancer C     423-224-5593        
MBCCOP - Meharry Medical College - Nashville Recruiting
Nashville, Tennessee, United States, 37208-3599
Contact: Steven N. Wolff, MD     615-327-6277        
Nashville Oncology Associates, PC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Steven N. Wolff, MD     615-327-6277        
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center     800-811-8480        
United States, Texas
Texas Oncology, PA - Austin North Recruiting
Austin, Texas, United States, 78759
Contact: Beth Hellerstedt     512-873-8900        
Southwest Regional Cancer Center - Central Recruiting
Austin, Texas, United States, 78705
Contact: Clinical Trials Office - Southwest Regional Cancer Center - Ce     512-421-4163        
Cancer Therapy and Research Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Clinical Trials Office - Cancer Therapy and Research Center     210-616-5798        
Texas Oncology, PA - Austin Northwest Recruiting
Austin, Texas, United States, 78759
Contact: Beth Hellerstedt     512-349-0081        
Texas Oncology, PA - San Marcos Recruiting
San Marcos, Texas, United States, 78666
Contact: Beth Hellerstedt     512-396-5199        
Texas Oncology, PA - Seton Williamson Recruiting
Round Rock, Texas, United States, 78665
Contact: Beth Hellerstedt     512-687-2300        
Texas Oncology, PA at South Austin Cancer Center Recruiting
Austin, Texas, United States, 78745
Contact: Beth Hellerstedt     512-447-2202        
University Hospital - San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Ian M. Thompson, Jr.     210-358-4000        
Texas Oncology, PA at Texas Oncology Cancer Center - Central Recruiting
Austin, Texas, United States, 78731
Contact: Beth Hellerstedt     512-302-1771        
Texas Oncology, PA at Texas Cancer Center Round Rock Recruiting
Round Rock, Texas, United States, 78681
Contact: Beth Hellerstedt     512-341-8724        
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Ian M. Thompson, Jr.     210-567-4777        
Veterans Affairs Medical Center - San Antonio (Murphy) Recruiting
San Antonio, Texas, United States, 78209
Contact: Ian M. Thompson, Jr.     210-617-5300        
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Health Care     802-656-8990        
Mountainview Medical Recruiting
Berlin, Vermont, United States, 05602
Contact: Steven Ades     802-223-6196        
United States, Virginia
Danville Regional Medical Center Recruiting
Danville, Virginia, United States, 24541
Contact: Clinical Trials Office - Danville Regional Medical Center     434-799-3753        
Southwest Virginia Regional Cancer Center at Wellmonth Health Recruiting
Norton, Virginia, United States, 24273
Contact: Malcolm R. Mathews, MD     423-224-3150        
United States, Washington
Allenmore Hospital Recruiting
Tacoma, Washington, United States, 98405
Contact: Lauren K. Colman, MD     253-403-1677        
Auburn Regional Center for Cancer Care Recruiting
Auburn, Washington, United States, 98002
Contact: Lauren K. Colman, MD     253-403-1677        
Cascade Cancer Center at Evergreen Hospital Medical Center Recruiting
Kirkland, Washington, United States, 98033
Contact: Jacqueline Vuky     425-899-3181        
CCOP - Northwest Recruiting
Tacoma, Washington, United States, 98405
Contact: Lauren K. Colman, MD     253-403-1677        
CCOP - Virginia Mason Research Center Recruiting
Seattle, Washington, United States, 98101
Contact: Jacqueline Vuky     206-341-0446        
Franciscan Cancer Center at St. Joseph Medical Center Recruiting
Tacoma, Washington, United States, 98405-3004
Contact: Clinical Trials Office - Franciscan Cancer Center     253-426-6914        
Good Samaritan Cancer Center Recruiting
Puyallup, Washington, United States, 98372
Contact: Lauren K. Colman, MD     253-403-1677        
Valley Medical Center Recruiting
Renton, Washington, United States, 98055
Contact: Jacqueline Vuky     425-228-3450        
Providence Centralia Hospital Recruiting
Centralia, Washington, United States, 98531-9027
Contact: Clinical Trials Office - Providence Centralia H     360-493-4300        
Providence St. Peter Hospital Regional Cancer Center Recruiting
Olympia, Washington, United States, 98506-5166
Contact: Lauren K. Colman, MD     253-403-1677        
Rockwood Clinic Cancer Treatment Center Recruiting
Spokane, Washington, United States, 99204-2967
Contact: Clinical Trials Office - Rockwood Clinic Cancer Treatment Cent     509-838-2531 ext. 6880        
St. Clare Hospital Recruiting
Tacoma, Washington, United States, 98499
Contact: Lauren K. Colman, MD     253-403-1677        
St. Francis Hospital Recruiting
Federal Way, Washington, United States, 98003
Contact: Lauren K. Colman, MD     253-403-1677        
MultiCare Regional Cancer Center at Tacoma General Hospital Recruiting
Tacoma, Washington, United States, 98405
Contact: Clinical Trials Office - MultiCare Regional Cancer Center     253-403-3229        
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Jacqueline Vuky     206-223-6600        
United States, West Virginia
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Recruiting
Huntington, West Virginia, United States, 25701
Contact: Oncology Research Supervisor     304-399-6617        
United States, Wisconsin
Regional Cancer Center at Oconomowoc Memorial Hospital Recruiting
Oconomowoc, Wisconsin, United States, 53066
Contact: Clinical Trials Office - Regional Cancer Center at Oconomowoc     262-928-7878        
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic - Green     414-649-5717        
Vince Lombardi Cancer Clinic - Marinette Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Dhimant R. Patel, MD     920-288-4180        
Waukesha Memorial Hospital Regional Cancer Center Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Clinical Trials Office - Waukesha Memorial Hospital Regional C     262-928-7632        
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital Recruiting
Sheridan, Wyoming, United States, 82801
Contact: Benjamin T. Marchello, MD     406-238-6290        
Canada, Alberta
Tom Baker Cancer Centre - Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Bernie (Bernhard) J.C. Eigl     403-521-3701        
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T 1Z4
Contact: Martin E. Gleave, MD     604-875-5003        
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Darrel E. Drachenberg     204-787-2241        
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Joseph L. Chin     519-685-8615        
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Alexandre R. Zlotta     416-946-2811        
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Pawel Zalewski     905-576-8711        
Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Investigators
Study Chair: James A. Eastham, MD Memorial Sloan-Kettering Cancer Center
Study Chair: Martin G. Sanda, MD Beth Israel Deaconess Medical Center
Study Chair: Martin E. Gleave, MD Vancouver General Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Featured trial article  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Cancer and Leukemia Group B ( Richard L. Schilsky )
Study ID Numbers: CDR0000526353, CALGB-90203
Study First Received: January 30, 2007
Last Updated: November 20, 2009
ClinicalTrials.gov Identifier: NCT00430183     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Goserelin
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Male
 Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Leuprolide
Fertility Agents, Female
Therapeutic Uses
Fertility Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009



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