Cancer Radiation Therapy |
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Clinical Trial: Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
This study is currently recruiting patients.
Purpose
RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer.
PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer stage IV prostate cancer | Drug: bicalutamide Drug: buserelin Drug: flutamide Drug: goserelin Drug: leuprolide Drug: nilutamide Procedure: ablative endocrine surgery Procedure: antiandrogen therapy Procedure: endocrine therapy Procedure: hormone therapy Procedure: orchiectomy Procedure: radiation therapy Procedure: releasing factor agonist therapy | Phase III |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Total Androgen Blockade With or Without Pelvic Irradiation in Patients With Locally Advanced Adenocarcinoma of the Prostate
OBJECTIVES:
- Compare the overall survival and time to progression in patients with locally advanced adenocarcinoma of the prostate treated with total androgen suppression with or without pelvic irradiation.
- Compare the symptomatic control as measured by the rates of surgical interventions needed for control of local disease (e.g., transurethral resections, stent insertions, nephrostomies, and colostomies) in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the sensitivity of the EORTC-QLQ-C30+3 and a trial-specific checklist (PR17) with the FACT-P questionnaire in measuring changes in quality of life of patients treated with these regimens.
OUTLINE: This a randomized, multicenter study. Patients are stratified according to center, initial PSA level (less than 20 vs 20-50 vs greater than 50 ng/mL), method of node staging (clinical [no CT scan] vs radiological [CT scan negative] vs surgical), Gleason score (less than 8 vs 8-10), prior hormonal therapy (excluding orchiectomy) (yes vs no), and choice of hormonal therapy (bilateral orchiectomy with or without antiandrogen vs luteinizing hormone-releasing hormone [LHRH] with antiandrogen). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive antiandrogen therapy comprising oral flutamide every 8 hours, oral nilutamide every 8 hours for 1 month and then once daily, or oral bicalutamide once daily. Patients also choose to undergo bilateral orchiectomy or LHRH agonist therapy comprising goserelin subcutaneously (SC) every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), leuprolide intramuscularly every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), or buserelin SC every 8 weeks or every 12 weeks. Patients choosing orchiectomy may receive an antiandrogen for at least 6 weeks before surgery to counter any flare phenomenon and may continue the antiandrogen after surgery (at the physician's discretion).
- Arm II: Patients undergo total androgen ablation as in arm I. Patients with node-negative dissection undergo radiotherapy 5 days a week for 6.5-7 weeks. All other patients undergo radiotherapy 5 days a week for 5 weeks, followed by boost radiotherapy 5 days a week for 2-2.4 weeks. Hormonal therapy on both arms continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on the last day of radiotherapy, at 6 months, and then every 6 months thereafter.
Patients are followed at 1, 2, and 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,200 patients will be accrued for this study within 7.5 years.
Eligibility
Ages Eligible for Study: up to 79 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically proven locally advanced adenocarcinoma of the prostate, defined as 1 of the following:
- T3-4, N0 or NX, M0
- T2, PSA greater than 40 µg/L
- T2, PSA greater than 20 µg/L AND Gleason score at least 8
- Diagnosis made within the past 6 months
- Gleason score and PSA known
- Pelvic lymph nodes must be clinically negative
- Lymph nodes no more than 1.5 cm in greatest diameter by CT scan or MRI of the pelvis
- Negative needle aspirate required for any lymph node more than 1.5 cm
- If a lymph node dissection was performed, it must be histologically negative
- No small cell or transitional cell carcinoma by biopsy
- No bony metastases by bone scan
PATIENT CHARACTERISTICS: Age:
- Under 80
Performance status:
- ECOG 0-2
Life expectancy:
- At least 5 years excluding malignancy
Hematopoietic:
- Hemoglobin at least 10.0 g/dL
- WBC at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 2 times upper limit of normal (ULN)
- SGOT and SGPT less than 2 times ULN
- Alkaline phosphatase less than 2 times ULN
- No history of chronic liver disease
Renal:
- Creatinine less than 2 times ULN
Other:
- No contraindication to wide-field pelvic irradiation (e.g., inflammatory bowel disease or severe bladder irritability)
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Prior hormonal therapy within the past 12 weeks allowed provided the following conditions are met:
- Negative bone scan before beginning any hormonal therapy
- Extracapsular extension remains palpable on rectal re-exam
- Baseline PSA known before beginning any hormonal therapy
- At least 4-6 weeks since prior 5-alpha-reductase inhibitor (e.g., finasteride) for benign prostatic hypertrophy
Radiotherapy:
- No prior pelvic irradiation
Surgery:
- No prior radical prostatectomy
- Prior transurethral resection of the prostate allowed
Other:
- No prior cytotoxic anticancer therapy
- No other prior treatment for prostate cancer
- No other concurrent anticancer therapy unless documented disease progression
Location and Contact Information
Alabama
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, 72205, United States; Recruiting
California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
University of California Davis Cancer Center, Sacramento, California, 95817, United States; Recruiting
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting
Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting
Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting
District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Florida
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141, United States; Recruiting
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7390, United States; Recruiting
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting
Louisiana
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71101-4295, United States; Recruiting
Massachusetts
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Providence Cancer Institute at Providence Hospital - Southfield, Southfield, Michigan, 48075, United States; Recruiting
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0946, United States; Recruiting
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting
Saint Louis University Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States; Recruiting
New York
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Western New York Urology Associates, Buffalo, New York, 14220, United States; Recruiting
North Carolina
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0501, United States; Recruiting
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-9001, United States; Recruiting
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States; Recruiting
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428-1002, United States; Recruiting
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States; Recruiting
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States; Recruiting
South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States; Recruiting
CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting
Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting
Brooke Army Medical Center, Fort Sam Houston, Texas, 78234-6200, United States; Recruiting
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting
Southwest Cancer and Research Center at University Medical Center, Lubbock, Texas, 79415-3364, United States; Recruiting
Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, 79106, United States; Recruiting
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229-3900, United States; Recruiting
University of Texas Medical Branch, Galveston, Texas, 77555-0565, United States; Recruiting
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting
Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States; Recruiting
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112-5550, United States; Recruiting
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States; Recruiting
Virginia
Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk, Virginia, 23510-1115, United States; Recruiting
Washington
CCOP - Northwest, Tacoma, Washington, 98405-0986, United States; Recruiting
CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States; Recruiting
Puget Sound Oncology Consortium, Seattle, Washington, 98109, United States; Recruiting
Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States; Recruiting
Canada, Alberta
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada; Recruiting
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, V1Y 5L3, Canada; Recruiting
British Columbia Cancer Agency, Vancouver, British Columbia, V5Z 4E6, Canada; Recruiting
Fraser Valley Cancer Centre at Surrey Memorial Hospital, Surrey, British Columbia, V3V 1Z2, Canada; Recruiting
Canada, Nova Scotia
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, B3H 1V7, Canada; Recruiting
Canada, Ontario
Algoma Regional Cancer Program at Sault Area Hospital, Sault Sainte Marie, Ontario, P6A 2C4, Canada; Recruiting
Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, N8W 2X3, Canada; Recruiting
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, N6A 4L6, Canada; Recruiting
Cancer Centre of Southeastern Ontario, Kingston, Ontario, K7L 5P9, Canada; Recruiting
Humber River Regional Hospital - Weston, Weston, Ontario, M9N 1N8, Canada; Recruiting
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, L8V 5C2, Canada; Recruiting
Northeastern Ontario Regional Cancer Centre, Sudbury, Ontario, P3E 5J1, Canada; Recruiting
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus, Ottawa, Ontario, K1H 1C4, Canada; Recruiting
Princess Margaret Hospital, Toronto, Ontario, M5G 2M9, Canada; Recruiting
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, P7B 6V4, Canada; Recruiting
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, M4N 3M5, Canada; Recruiting
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, H2L 4MI, Canada; Recruiting
McGill Cancer Centre, Montreal, Quebec, H2W 1S6, Canada; Recruiting
Canada, Saskatchewan
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, S7N 4H4, Canada; Recruiting
United Kingdom, Wales
Velindre Cancer Center at Velinde Hospital, Cardiff, Wales, CF14 2TL, United Kingdom; Recruiting
Padraig R. Warde, MB, MRCPI, FRCPC, Study Chair, Princess Margaret Hospital
Richard R. Whittington, MD, Study Chair, University of Pennsylvania Cancer Center
Srinivasan Vijayakumar, MD, Study Chair, Michael Reese Hospital & Medical Center
Patricia Lillis-Hearne, MD, Study Chair, Brooke Army Medical Center
Malcolm D. Mason, MD, Study Chair, Velindre Cancer Center at Velinde Hospital
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: October 2004
Last Updated: March 28, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002633
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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