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

NCT00430183 | Active Not Recruiting Phase 3 Results DMC

• 3 other identifiers: CALGB 90203U10CA031946CDR0000526353
• Study Type: interventional
• Target: 788
• Locations: 2 countries
• Sites: 226

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Proportion of Biochemical Progression-Free Survival (bPFS Proportion) at 3 Years

  Proportion of participants surviving 3 years from randomization without biochemical progression or death. bPFS was defined as the time from randomization to the date of the first documented biochemical progression or death. Progression will be defined as having experienced either of the following: a serum PSA level \> 0.2 ng/mL that increases on 2 consecutive occasions each of which is at least 3 months apart or death occurs. The time of biochemical failure is measured from the date of randomization to the date of the first PSA level \> 0.2 ng/mL.

  Up to 3 years

Secondary Outcomes (7)

• 5-year bPFS Rate

  5 years

• Time to Clinical Local Recurrence (The Time From Randomization to the First Biopsy-proven Recurrence in the Prostatic Bed or New Mass.)

  Up to 15 years post-randomization

• Time to Metastatic Disease Progression (The Date of Randomization to Date of Evidence of Systemic Disease on Bone Scan or Cross Sectional Imaging.)

  Up to 15 years post-randomization

• Unacceptable Toxicity (Grade 3 or Higher Toxicity)

  Up to 15 years post-randomization

• Prostate Cancer-specific-free Survival (The Time From Randomization to the Time of Death Due to Prostate Cancer.)

  Up to 15 years post-randomization

Study Arms (2)

Arm A: docetaxel + LHRH agonist + surgical intervention

EXPERIMENTAL

Patients receive six cycles of docetaxel administered every 3 weeks combined with 18-24 weeks of androgen deprivation therapy. During each cycle of chemotherapy, all patients should undergo premedication with dexamethasone 8 mg orally prior to docetaxel. Dexamethasone may also be given intravenously according to institutional guidelines. Patients will also receive androgen deprivation for 18-24 weeks of an LHRH agonist (eg, leuprolide acetate, goserelin acetate). Additional premedication and antiemetics may be given at the physician's discretion and as defined by the protocol. Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.

Drug: docetaxel; Drug: LHRH agonist; Procedure: surgery

Arm B: surgical intervention

OTHER

All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery.

Procedure: surgery

Interventions

docetaxel DRUG

75 mg/m\^2 will be administered intravenously over one hour on Day 1 of each cycle, every 21 days

Arm A: docetaxel + LHRH agonist + surgical intervention

LHRH agonist DRUG

Given intramuscularly

Also known as: leuprolide acetate OR, goserelin acetate

Arm A: docetaxel + LHRH agonist + surgical intervention

surgery PROCEDURE

Patients undergo radical prostatectomy with staging pelvic lymphadenectomy.

Arm A: docetaxel + LHRH agonist + surgical intervention; Arm B: surgical intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. Histologic documentation - Histologic documentation of prostatic adenocarcinoma. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible. All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration. 2. Clinically localized disease - Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by: * EITHER CT or MRI of the abdomen and pelvis, OR endorectal MRI of the pelvis that demonstrate no nodes \> 1.5 cm. If one or more pelvic lymph node(s) measures \> 1.5 cm, a negative biopsy is required. If more than one lymph node is \> 1.5 cm, the largest or most accessible node should be biopsied. AND * Negative bone scan (with plain films and/or MRI and/or CT scan confirmation, if necessary). Positive PET and Prostascint scans are not considered proof of metastatic disease. 3. Determination of high-risk status: Patients must have either: * A Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of \< 60%. OR * Prostate biopsy Gleason sum ≥ 8 (NOTE: The Kattan nomogram probability must be calculated for all patients, including those eligible based on Gleason sum ≥ 8 only.) 4. Prior treatment - No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy. Patients may have received up to 4 months of androgen deprivation therapy (LHRH agonists, antiandrogens, or both) prior to being enrolled on the study. 5. Appropriate surgical candidates - Patients must be appropriate candidates for radical prostatectomy with an estimated life expectancy \> 10 years as determined by a urologist. Evidence of underlying cardiac disease should be evaluated prior to enrollment to ensure that patients are not at high risk of cardiac complications. 6. Clotting history - Patients with a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation are eligible provided they are determined to be candidates for radical prostatectomy. 7. ECOG performance status: 0-2 8. Age: ≥ 18 years of age 9. Required Initial Laboratory Values: * ANC ≥ 1500/μL * Platelet count ≥ 150,000/μL * Creatinine ≤ 2.0 mg/dL * Pre-registration serum PSA level ≤ 100 ng/mL * Bilirubin ≤ 1.5XULN (2.5XULN in patients with Gilbert's disease) * AST/ALT ≤1.5XULN

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator
• NCIC Clinical Trials Group: collaborator
• SWOG Cancer Research Network: collaborator

Study Sites (226)

Providence Cancer Center

Anchorage, Alaska, 99508, United States

Location

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

Location

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Sutter Health - Western Division Cancer Research Group

Novato, California, 94945, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Naval Medical Center - San Diego

San Diego, California, 92134, United States

Location

California Pacific Medical Center - Pacific Campus

San Francisco, California, 94118, United States

Location

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403, United States

Location

Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

Sutter Solano Medical Center

Vallejo, California, 94589, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Shaw Regional Cancer Center

Edwards, Colorado, 81632, United States

Location

Valley View Hospital Cancer Center

Glenwood Springs, Colorado, 81601, United States

Location

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, 81401, United States

Location

Helen and Harry Gray Cancer Center at Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Veterans Affairs Medical Center - West Haven

West Haven, Connecticut, 06516, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803-1273, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Cleveland Clinic Florida - Weston

Weston, Florida, 33331, United States

Location

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, 96813, United States

Location

Hawaii Medical Center - East

Honolulu, Hawaii, 96817, United States

Location

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, 96817, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Castle Medical Center

Kailua, Hawaii, 96734, United States

Location

Kauai Medical Clinic

Lihue, Hawaii, 96766, United States

Location

Maui Memorial Medical Center

Wailuku, Hawaii, 96793, United States

Location

Pacific Cancer Institute - Maui

Wailuku, Hawaii, 96793, United States

Location

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Idaho Urologic Institute, PA

Meridian, Idaho, 83642, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Delnor Hospital - Geneva

Geneva, Illinois, 60134, United States

Location

Veterans Affairs Medical Center - Hines

Hines, Illinois, 60141, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Central Dupage Cancer Center

Warrenville, Illinois, 60555, United States

Location

Elkhart Clinic, LLC

Elkhart, Indiana, 46514-2098, United States

Location

Michiana Hematology-Oncology, PC - Elkhart

Elkhart, Indiana, 46514, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, 46545-1470, United States

Location

Saint Joseph Regional Medical Center

Mishawaka, Indiana, 46545-1470, United States

Location

Michiana Hematology Oncology PC - Plymouth

Plymouth, Indiana, 46563, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Michiana Hematology Oncology PC - La Porte

Westville, Indiana, 46391, United States

Location

Hematology Oncology Associates of the Quad Cities

Bettendorf, Iowa, 52722, United States

Location

Genesis Regional Cancer Center at Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

St. Rose Ambulatory and Surgery Center

Great Bend, Kansas, 67530, United States

Location

Hays Medical Center

Hays, Kansas, 67601, United States

Location

Hutchinson Hospital Corporation

Hutchinson, Kansas, 67502, United States

Location

Kansas City Cancer Centers - West

Kansas City, Kansas, 66112, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Kansas City Cancer Centers - Southwest

Overland Park, Kansas, 66210, United States

Location

Mount Carmel Regional Cancer Center

Pittsburg, Kansas, 66762, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Kansas City Cancer Center - Shawnee Mission

Shawnee Mission, Kansas, 66204, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Pennington Cancer Center at Baton Rouge General

Baton Rouge, Louisiana, 70806, United States

Location

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Medical Center of Louisiana - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, 04074, United States

Location

Union Hospital of Cecil County

Elkton, Maryland, 21921, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

Tufts Medical Center Cancer Center

Boston, Massachusetts, 02111, United States

Location

Berkshire Hematology Oncology, PC

Pittsfield, Massachusetts, 01201, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Mecosta County Medical Center

Big Rapids, Michigan, 49307, United States

Location

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123-2500, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Foote Memorial Hospital

Jackson, Michigan, 49201, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48912-1811, United States

Location

St. Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Mercy General Health Partners

Muskegon, Michigan, 49444, United States

Location

St. Joseph Mercy Oakland

Pontiac, Michigan, 48341-2985, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Spectrum Health Reed City Hospital

Reed City, Michigan, 49677, United States

Location

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, 48601, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, 49085, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Minnesota Oncology - Maplewood

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

New Ulm Medical Center

New Ulm, Minnesota, 56073, United States

Location

Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, 56303, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, 55379, United States

Location

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Willmar Cancer Center at Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

Minnesota Oncology - Woodbury

Woodbury, Minnesota, 55125, United States

Location

University of Mississippi Cancer Clinic

Jackson, Mississippi, 39216, United States

Location

Truman Medical Center - Hospital Hill

Kansas City, Missouri, 64108, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

Kansas City Cancer Centers - South

Kansas City, Missouri, 64131, United States

Location

Kansas City Cancer Centers - North

Kansas City, Missouri, 64154, United States

Location

Kansas City Cancer Centers - East

Lee's Summit, Missouri, 64064, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59102, United States

Location

Billings Clinic

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Benefis Healthcare - Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Lakeside Hospital

Omaha, Nebraska, 68130, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131-2197, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

Concord, New Hampshire, 03301, United States

Location

New Hampshire Oncology - Hematology, PA - Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, 08053, United States

Location

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, 07960, United States

Location

Somerset Medical Center

Somerville, New Jersey, 08876, United States

Location

Frederick R. and Betty M. Smith Cancer Treatment Center

Sparta, New Jersey, 07871, United States

Location

Overlook Hospital

Summit, New Jersey, 07901, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Voorhees Township, New Jersey, 08043, United States

Location

Hematology Oncology Associates, PC

Albuquerque, New Mexico, 87106, United States

Location

Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital

Albuquerque, New Mexico, 87110, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

Carolinas Medical Center - Union

Monroe, North Carolina, 28112, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Cleveland Regional Medical Center

Shelby, North Carolina, 28150, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

St. Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Bay Area Hospital

Coos Bay, Oregon, 97420, United States

Location

Kaiser Permanente Health Care - Portland

Portland, Oregon, 97227, United States

Location

Mercy Fitzgerald Hospital

Darby, Pennsylvania, 19023, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

Roper St. Francis Cancer Center at Roper Hospital

Charleston, South Carolina, 29401, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37662, United States

Location

MBCCOP - Meharry Medical College - Nashville

Nashville, Tennessee, 37208-3599, United States

Location

Mountainview Medical

Berlin Corners, Vermont, 05602, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Lynchburg Hematology-Oncology Clinic

Lynchburg, Virginia, 24501, United States

Location

Southwest Virginia Regional Cancer Center at Wellmonth Health

Norton, Virginia, 24273, United States

Location

Providence Centralia Hospital

Centralia, Washington, 98531-9027, United States

Location

St. Francis Hospital

Federal Way, Washington, 98003, United States

Location

Cascade Cancer Center at Evergreen Hospital Medical Center

Kirkland, Washington, 98033, United States

Location

Seattle Cancer Care Alliance at EvergreenHealth

Kirkland, Washington, 98034, United States

Location

Providence St. Peter Hospital Regional Cancer Center

Olympia, Washington, 98506-5166, United States

Location

Good Samaritan Cancer Center

Puyallup, Washington, 98372, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Pacific Medical Center

Seattle, Washington, 98104, United States

Location

Rockwood Clinic Cancer Treatment Center

Spokane, Washington, 99204-2967, United States

Location

Franciscan Cancer Center at St. Joseph Medical Center

Tacoma, Washington, 98405-3004, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405, United States

Location

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center - Tacoma

Tacoma, Washington, 98431, United States

Location

St. Clare Hospital

Tacoma, Washington, 98499, United States

Location

West Virginia University Health Sciences Center - Charleston

Charleston, West Virginia, 25304, United States

Location

Edwards Comprehensive Cancer Center at Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

Rocky Mountain Oncology

Casper, Wyoming, 82609, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

University of British Columbia

Vancouver, British Columbia, V5Z 3P1, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

• Eastham JA, Heller G, Halabi S, Monk JP 3rd, Beltran H, Gleave M, Evans CP, Clinton SK, Szmulewitz RZ, Coleman J, Hillman DW, Watt CR, George S, Sanda MG, Hahn OM, Taplin ME, Parsons JK, Mohler JL, Small EJ, Morris MJ. Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer. J Clin Oncol. 2020 Sep 10;38(26):3042-3050. doi: 10.1200/JCO.20.00315. Epub 2020 Jul 24.

  PMID: 32706639 DERIVED

Related Links

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Gonadotropin-Releasing Hormone; Leuprolide; Goserelin; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: James A. Eastham, MD
• Organization: Memorial Sloan-Kettering Cancer Center

easthamj@mskcc.org

646-422-4390

Study Officials

• James Eastham, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: February 1, 2007
• Study Start: May 8, 2007
• Primary Completion: October 2, 2018
• Study Completion (Estimated): October 1, 2030
• Last Updated: February 9, 2023
• Results First Posted: January 13, 2020

Record last verified: 2023-02

Locations

CA (5); US (221)