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Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bicalutamide
docetaxel
doxorubicin hydrochloride
estramustine phosphate sodium
flutamide
ketoconazole
paclitaxel
releasing hormone agonist therapy
vinblastine sulfate
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of adenocarcinoma of the prostate Failed local treatments (surgery and/or radiotherapy and/or brachytherapy) as defined by a rising prostate-specific antigen level of at least 2.0 ng/mL (confirmed by 2 measurements at least 2 weeks apart) and a doubling time of 32 weeks or less No clinical or radiographic evidence of disease Original Gleason score of at least 7 OR Gleason score of 6 with capsular penetration or positive seminal vesicles or lymph nodes No metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL No history of bleeding disorders that would contraindicate warfarin, including clotting factor defects Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Blood Urea Nitrogen (BUN) no greater than 1.2 times normal Cardiovascular: No symptomatic heart disease No history of myocardial infarction No history of thromboembolic events (e.g., deep vein thrombosis, symptomatic cerebrovascular events, or pulmonary embolism) Other: No other major medical or psychiatric illness that would preclude study entry No other prior or concurrent invasive malignancy within the past 5 years except superficial skin cancer No history of esophageal varices Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior vaccine therapy Chemotherapy: At least 5 years since prior chemotherapy Endocrine therapy: Prior adjuvant or neoadjuvant hormonal therapy of less than 8 months duration allowed At least 1 year since prior androgen therapy Radiotherapy: See Disease Characteristics At least 5 years since prior radiotherapy to sites other than prostate Surgery: See Disease Characteristics Other: Concurrent warfarin allowed Concurrent bisphosphonate therapy initiated prior to or after randomization allowed

Sites / Locations

  • Foundation for Cancer Research and Education
  • Veterans Affairs Medical Center - Tucson
  • Veterans Affairs Medical Center - Little Rock
  • Veterans Affairs Outpatient Clinic - Martinez
  • Medical Center of Aurora - South Campus
  • Boulder Community Hospital
  • Memorial Hospital Cancer Center
  • Penrose Cancer Center at Penrose Hospital
  • Porter Adventist Hospital
  • St. Joseph Hospital
  • Presbyterian - St. Luke's Medical Center
  • Rocky Mountain Cancer Centers - Denver Rose
  • CCOP - Colorado Cancer Research Program, Incorporated
  • Swedish Medical Center
  • Sky Ridge Medical Center
  • Hope Cancer Care Center at Longmont United Hospital
  • St. Mary-Corwin Regional Medical Center
  • Rocky Mountain Cancer Centers - Thornton
  • Shands Cancer Center at the University of Florida Health Science Center
  • University of Miami Sylvester Comprehensive Cancer Center
  • Gulf Coast Cancer Treatment Center
  • Tallahassee Memorial Hospital
  • Veterans Affairs Medical Center - Tampa (Haley)
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
  • Veterans Affairs Medical Center - Hines
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
  • John Stoddard Cancer Center at Iowa Lutheran Hospital
  • Wendt Regional Cancer Center at Finley Hospital
  • Veterans Affairs Medical Center - Wichita
  • Veterans Affairs Medical Center - Lexington
  • Veterans Affairs Medical Center - New Orleans
  • Veterans Affairs Medical Center - Shreveport
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • University of Michigan Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Detroit
  • West Michigan Cancer Center
  • Veterans Affairs Medical Center - Jackson
  • Cancer Research for the Ozarks
  • Midlands Cancer Center at Midlands Community Hospital
  • Veterans Affairs Medical Center - Albuquerque
  • MBCCOP - University of New Mexico HSC
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • Lipson Cancer and Blood Center at Rochester General Hospital
  • CCOP - Southeast Cancer Control Consortium
  • Akron General's McDowell Cancer Center
  • Akron City Hospital at Summa Health System
  • Veterans Affairs Medical Center - Cincinnati
  • Veterans Affairs Medical Center - Dayton
  • Cancer Care Center, Incorporated
  • Cancer Treatment Center
  • Veterans Affairs Medical Center - Portland
  • Mercy Fitzgerald Hospital
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Fox Chase Cancer Center
  • Mercy Hospital Cancer Center - Scranton
  • Veterans Affairs Medical Center - Charleston
  • CCOP - Greenville
  • Rapid City Regional Hospital
  • Erlanger Cancer Center
  • Veterans Affairs Medical Center - Memphis
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • Veterans Affairs Medical Center - Amarillo
  • University of Texas Medical Branch
  • Veterans Affairs Medical Center - San Antonio (Murphy)
  • Veterans Affairs Medical Center - Temple
  • Cottonwood Hospital Medical Center
  • McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center - Provo
  • Dixie Regional Medical Center
  • Veterans Affairs Medical Center - Salt Lake City
  • Veterans Affairs Medical Center - Seattle
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • CCOP - Marshfield Clinic Research Foundation
  • All Saints Cancer Center at All Saints Healthcare
  • Westmead Hospital
  • Instituto de Enfermedades Neoplasicas
  • San Juan City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Androgen blockade + immediate chemotherapy

Androgen blockade + delayed chemotherapy

Arm Description

Androgen blockade with immediate chemotherapy

Androgen blockade with delayed chemotherapy

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Biochemical control
Time to Clinical Failure
Frequency of non-hematologic (>= grade 3), hematologic (grade >=4) and fatal (grade 5) toxicities

Full Information

First Posted
February 14, 2002
Last Updated
October 21, 2020
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, SWOG Cancer Research Network, NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00030654
Brief Title
Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
Official Title
A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
February 4, 2005 (Actual)
Study Completion Date
February 4, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, SWOG Cancer Research Network, NRG Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer.
Detailed Description
OBJECTIVES: Primary Compare the survival of patients with high-risk hormone-naive prostate cancer treated with androgen blockade with concurrent chemotherapy vs delayed chemotherapy. Secondary Compare biochemical control in patients treated with these regimens. Determine the toxicity of these regimens in these patients. Compare the time to clinical failure, as measured by progression on bone scan or CT scan or a prostate-specific antigen (PSA) doubling time of ≤ 32 weeks, in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), original combined Gleason score (6 vs 7 vs 8-10), and prior vaccine therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive androgen blockade (AB) comprising a luteinizing-hormone releasing-hormone agonist continuously and oral flutamide or oral bicalutamide once daily for at least 1 month. Within 4 weeks of initiation of AB, patients begin chemotherapy. Patients receive 1, and only 1, of the following chemotherapy regimens: Regimen A: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV on day 3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen B: Patients receive oral estramustine 3 times daily on days 1-5 and paclitaxel IV on days 3, 10, 17, 24, 31, and 38. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen C: Patients receive oral ketoconazole 3 times daily on days 1-7, 15-21, and 29-35; doxorubicin IV on days 1, 15, and 29; vinblastine IV on days 8, 22, and 36; and oral estramustine 3 times daily on days 8-14, 22-28, and 36-42. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen D: Patients receive oral estramustine 3 times daily on days 1-4 and docetaxel IV over 1 hour on days 3, 10, and 17. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen E: Patients receive docetaxel IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen F: Patients receive docetaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen G: With approval from the protocol chair, patients may receive a regimen that has been demonstrated in a published phase II study to have at least a 50% response rate as measured by PSA decrease from baseline over 2 measurements 28 days apart or a decrease in measurable soft tissue disease by 50% in 2 dimensions. Arm II: Patients receive AB as in arm I. Patients continue with AB until clinical failure, at which time patients receive chemotherapy as in arm I. Patients who have a response may continue to receive chemotherapy beyond 4 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,050 patients will be accrued for this study within 4-6 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Androgen blockade + immediate chemotherapy
Arm Type
Experimental
Arm Description
Androgen blockade with immediate chemotherapy
Arm Title
Androgen blockade + delayed chemotherapy
Arm Type
Experimental
Arm Description
Androgen blockade with delayed chemotherapy
Intervention Type
Drug
Intervention Name(s)
bicalutamide
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
estramustine phosphate sodium
Intervention Type
Drug
Intervention Name(s)
flutamide
Intervention Type
Drug
Intervention Name(s)
ketoconazole
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
releasing hormone agonist therapy
Intervention Type
Drug
Intervention Name(s)
vinblastine sulfate
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
From date of randomization to the date of death due to any cause
Secondary Outcome Measure Information:
Title
Biochemical control
Time Frame
From date of randomization to the date of first PSA failure defined as a PSA doubling time <= 32 weeks
Title
Time to Clinical Failure
Time Frame
Time from study entry to positive scan or positive disease evaluation of the pelvis or chest or a PSA doubling time ≤ 32 weeks
Title
Frequency of non-hematologic (>= grade 3), hematologic (grade >=4) and fatal (grade 5) toxicities
Time Frame
From the beginning of treatment to 90 days post treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of adenocarcinoma of the prostate Failed local treatments (surgery and/or radiotherapy and/or brachytherapy) as defined by a rising prostate-specific antigen level of at least 2.0 ng/mL (confirmed by 2 measurements at least 2 weeks apart) and a doubling time of 32 weeks or less No clinical or radiographic evidence of disease Original Gleason score of at least 7 OR Gleason score of 6 with capsular penetration or positive seminal vesicles or lymph nodes No metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL No history of bleeding disorders that would contraindicate warfarin, including clotting factor defects Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Blood Urea Nitrogen (BUN) no greater than 1.2 times normal Cardiovascular: No symptomatic heart disease No history of myocardial infarction No history of thromboembolic events (e.g., deep vein thrombosis, symptomatic cerebrovascular events, or pulmonary embolism) Other: No other major medical or psychiatric illness that would preclude study entry No other prior or concurrent invasive malignancy within the past 5 years except superficial skin cancer No history of esophageal varices Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior vaccine therapy Chemotherapy: At least 5 years since prior chemotherapy Endocrine therapy: Prior adjuvant or neoadjuvant hormonal therapy of less than 8 months duration allowed At least 1 year since prior androgen therapy Radiotherapy: See Disease Characteristics At least 5 years since prior radiotherapy to sites other than prostate Surgery: See Disease Characteristics Other: Concurrent warfarin allowed Concurrent bisphosphonate therapy initiated prior to or after randomization allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth J. Pienta, MD, FACP
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Naomi S. Balzer-Haas, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Arif Hussain, MD
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gregory P. Swanson, MD
Organizational Affiliation
Deaconess Medical Center, Spokane, Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Primo N. Lara, MD
Organizational Affiliation
University of California, Davis
Official's Role
Study Chair
Facility Information:
Facility Name
Foundation for Cancer Research and Education
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Veterans Affairs Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Veterans Affairs Medical Center - Little Rock
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Veterans Affairs Outpatient Clinic - Martinez
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
Facility Name
Medical Center of Aurora - South Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012-0000
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-9019
Country
United States
Facility Name
Memorial Hospital Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Penrose Cancer Center at Penrose Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80933
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
St. Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1191
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Denver Rose
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program, Incorporated
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Hope Cancer Care Center at Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
St. Mary-Corwin Regional Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Thornton
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80221
Country
United States
Facility Name
Shands Cancer Center at the University of Florida Health Science Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0385
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Gulf Coast Cancer Treatment Center
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405-4587
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Veterans Affairs Medical Center - Tampa (Haley)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Veterans Affairs Medical Center - Hines
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316-2301
Country
United States
Facility Name
Wendt Regional Cancer Center at Finley Hospital
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
Facility Name
Veterans Affairs Medical Center - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67218
Country
United States
Facility Name
Veterans Affairs Medical Center - Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502-2236
Country
United States
Facility Name
Veterans Affairs Medical Center - New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Veterans Affairs Medical Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101-4295
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0010
Country
United States
Facility Name
Veterans Affairs Medical Center - Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1932
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Veterans Affairs Medical Center - Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Midlands Cancer Center at Midlands Community Hospital
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68128-4157
Country
United States
Facility Name
Veterans Affairs Medical Center - Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5138
Country
United States
Facility Name
MBCCOP - University of New Mexico HSC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Lipson Cancer and Blood Center at Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
Akron General's McDowell Cancer Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Akron City Hospital at Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Veterans Affairs Medical Center - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220-2288
Country
United States
Facility Name
Veterans Affairs Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428-1002
Country
United States
Facility Name
Cancer Care Center, Incorporated
City
Salem
State/Province
Ohio
ZIP/Postal Code
44460
Country
United States
Facility Name
Cancer Treatment Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Veterans Affairs Medical Center - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207
Country
United States
Facility Name
Mercy Fitzgerald Hospital
City
Darby
State/Province
Pennsylvania
ZIP/Postal Code
19023
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Mercy Hospital Cancer Center - Scranton
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18501
Country
United States
Facility Name
Veterans Affairs Medical Center - Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57709
Country
United States
Facility Name
Erlanger Cancer Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Veterans Affairs Medical Center - Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5671
Country
United States
Facility Name
Veterans Affairs Medical Center - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0209
Country
United States
Facility Name
Veterans Affairs Medical Center - San Antonio (Murphy)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Veterans Affairs Medical Center - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Facility Name
Cottonwood Hospital Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Regional Medical Center - Provo
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Dixie Regional Medical Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Veterans Affairs Medical Center - Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
Veterans Affairs Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
All Saints Cancer Center at All Saints Healthcare
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Instituto de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
San Juan City Hospital
City
San Juan
ZIP/Postal Code
00936-7344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
16986043
Citation
Sandler HM, Pienta KJ. Rationale for the Radiation Therapy Oncology Group Study RTOG P-0014. Rev Urol. 2003;5 Suppl 2(Suppl 2):S28-34.
Results Reference
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Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

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