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Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer Clinical research trials and Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer. Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
For Condition: stage 2 prostate cancer,stage 3 prostate cancer
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI),National Cancer Institute of Canada
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining radiation therapy with hormone therapy may be an effective treatment for stage II or stage III prostate cancer. It is not yet known if radiation therapy combined with hormone therapy is more effective than either radiation therapy alone or hormone therapy alone in treating stage II or stage III prostate cancer. (Hormone therapy alone group closed as of 12/9/2002.) PURPOSE: Randomizedphase III trial to compare the effectiveness of radiation therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in treating patients who have stage II or stage III prostate cancer.
Details: OBJECTIVES: - Compare the overall survival, disease-free survival, freedom from distant metastases, and freedom from PSA failure in patients with high-risk stage II or III prostate cancer treated in the adjuvant setting with radiotherapy and hormonal therapy vs radiotherapy alone. - Compare the qualitative and quantitative toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to seminal vesicle invasion (yes vs no), preoperative PSA (10 ng/mL or less vs greater than 10 ng/mL), Gleason score (2-6 vs 7 vs 8-10), positive surgical margins (yes vs no), and neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms. (Arm III closed to accrual as of 12/9/2002.) - Arm I: Patients undergo radiotherapy once daily 5 days a week for 7 weeks. Beginning the first day of radiotherapy, patients also receive hormonal therapy comprising goserelin subcutaneously OR leuprolide intramuscularly once every 1-4 months for 2 years AND oral flutamide 3 times daily OR oral bicalutamide once daily for 1 month. - Arm II: Patients undergo radiotherapy as in arm I. - Arm III (Closed to accrual as of 12/9/2002):Patients receive hormonal therapy as in arm I. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,398 patients (699 per treatment arm) will be accrued for this study within 5 years. (Arm III closed to accrual as of 12/9/2002.)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed prostate cancer - T2-3, N0, M0 - No metastatic disease - High-risk for PSA relapse as defined by Gleason score 7 or higher and at least 1 of the following OR Gleason score less than 7 and at least 2 of the following: - Preoperative PSA greater than 10 ng/mL - Positive surgical margins - Seminal vesicle invasion - Preoperative PSA no greater than 40.0 ng/mL - Postoperative PSA no greater than 0.2 ng/mL - Negative lymph node status by lymph node sampling or dissection - If lymph node status is unknown, must have less than 5% risk of involvement by Roach formula PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 130,000/mm^3 - Hemoglobin at least 11.4 g/dL Hepatic: - ALT no greater than 3 times normal Renal: - Creatinine no greater than 2.5 mg/dL Other: - No other prior or concurrent invasive malignancy within the past 5 years except superficial nonmelanoma skin cancer - No other major medical or psychiatric illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 5 years since prior chemotherapy Endocrine therapy: - At least 60 days since prior finasteride - At least 90 days since prior testosterone - Prior pharmacologic androgen ablation for prostate cancer allowed if initiated within the past 10 months (must switch to study ablation therapy OR discontinue therapy if randomized to receive radiotherapy only) Radiotherapy: - No prior radiotherapy to the pelvis Surgery: - No prior orchiectomy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardValicenti, Study Chair, Kimmel Cancer Center (KCC)
Mount Diablo Medical Center *Recruiting*
Concord, California, 94524-4110
United States
Recruiting Daniel Chinn 925-674-2521
Utah Valley Regional Medical Center - Provo *Recruiting*
Provo, Utah, 84604
United States
Recruiting Tarlton Blair 801-373-7850 ext. 2480
Delaware County Memorial Hospital *Recruiting*
Drexel Hill, Pennsylvania, 19026
United States
Recruiting Rachelle Lanciano 610-284-8240
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha, Nebraska, 68114-4199
United States
Recruiting James Wheeler 402-354-4104
State University of New York Health Science Center at Brooklyn *Recruiting*
Brooklyn, New York, 11203
United States
Recruiting Marvin Rotman 718-270-2181
Newfoundland Cancer Treatment and Research Foundation *Recruiting*
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Recruiting Pradip Ganguly 709-777-8098
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Atlantic City Medical Center *Recruiting*
Pomona, New Jersey, 08240
United States
Recruiting Jorge Cassir 609-652-3417
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Daniel Petereit 605-719-2360
Bloomington Hospital *Recruiting*
Bloomington, Indiana, 47402
United States
Recruiting David Y. Lee 812-353-9633
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting N. Mariados 315-472-7504
Methodist Cancer Center at Methodist Hospital *Recruiting*
Indianapolis, Indiana, 46206-1367
United States
Recruiting Peter Garrett 317-926-3172
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting Lawrence Berk 614-566-9506
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0385
United States
Recruiting William Mendenhall 352-265-0287
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905-0001
United States
Recruiting Michael Haddock 507-284-2669
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Himu Lukka 905-387-9495 ext. 64702
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Christopher Koprowski 302-733-1830
University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle, Washington, 98195-6043
United States
Recruiting David Schwartz 206-768-5356
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Judith Figura 412-578-1923
Baptist Hospital of Miami *Recruiting*
Miami, Florida, 33256-2110
United States
Recruiting Andre Abitbol 305-596-6566
Methodist Medical Center of Illinois *Recruiting*
Peoria, Illinois, 61636
United States
Recruiting Revathi Swaminathan 309-672-5700
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0010
United States
Recruiting Howard Sandler 734-936-9338
Champlain Valley Physicians Hospital Medical Center *Recruiting*
Plattsburgh, New York, 12901-1490
United States
Recruiting Anthony Vaccaro 518-562-7120
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital *Recruiting*
Allentown, Pennsylvania, 18105
United States
Recruiting Victor Risch 610-402-0700
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Richard Choo 416-480-6165
Mercy Fitzgerald Hospital *Recruiting*
Darby, Pennsylvania, 19023
United States
Recruiting Leslie Tupchong 610-237-4370
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Elizabeth Gore 414-805-4465
Reading Hospital and Medical Center *Recruiting*
Reading, Pennsylvania, 19612-6052
United States
Recruiting Albert Yuen 610-988-8067
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Paul Okunieff 585-275-5575
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting William Sause 801-408-1146
Providence Saint Joseph Medical Center - Burbank *Recruiting*
Burbank, California, 91505
United States
Recruiting Nancy Ellerbroek 818-847-3440
Adena Regional Medical Center *Recruiting*
Chillicothe, Ohio, 45601
United States
Recruiting Contact Person 740-779-7500
Ball Memorial Hospital Cancer Center *Recruiting*
Muncie, Indiana, 47303-3499
United States
Recruiting Anthony Tilmans 765-747-3827
CCOP - Montana Cancer Consortium *Recruiting*
Billings, Montana, 59101
United States
Recruiting Robert Pfeffer 406-259-2245
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Adir Ludin 216-844-5432
All Saints Cancer Center at All Saints Healthcare *Recruiting*
Racine, Wisconsin, 53405
United States
Recruiting James Taylor 262-687-5000
Akron City Hospital *Recruiting*
Akron, Ohio, 44304
United States
Recruiting William Demas 330-375-3557
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Eugen Hug 603-650-6600
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Benjamin Movsas 215-728-3631
West Tennessee Cancer Center at Jackson-Madison County General Hospital *Recruiting*
Jackson, Tennessee, 38301
United States
Recruiting J.J. Kovalic 901-425-6250
Tallahassee Memorial Hospital *Recruiting*
Tallahassee, Florida, 32308
United States
Recruiting Timothy Bolek 850-431-5255
CCOP - Bay Area Tumor Institute *Recruiting*
Oakland, California, 94609-3305
United States
Recruiting Brenda Shank 510-456-8570
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Minesh Mehta 608-263-8500
Community Medical Center *Recruiting*
Toms River, New Jersey, 08755
United States
Recruiting Bong Chang 732-557-8148
Waukesha Memorial Hospital Regional Cancer Center *Recruiting*
Waukesha, Wisconsin, 53188
United States
Recruiting Wingate Clapper 262-928-2439
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Michael Zurenko 864-241-6251
South Jersey Regional Cancer Center *Recruiting*
Millville, New Jersey, 08332
United States
Recruiting Joseph Fanelle 856-293-2910
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting Ray Richards 801-688-4175
Wellspan Health - York Cancer Center *Recruiting*
York, Pennsylvania, 17403
United States
Recruiting Ronald Malcom 717-741-8100
McLaren Regional Cancer Center *Recruiting*
Flint, Michigan, 48532-3685
United States
Recruiting Hesham Gayar 810-342-3800
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54301
United States
Recruiting Thomas Saphner 920-432-5134
Monmouth Medical Center *Recruiting*
Long Branch, New Jersey, 07740-6395
United States
Recruiting Smitha Gollamudi 732-923-6890
CCOP - Scott and White Hospital *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting Cathy Clausen 309-636-3605
Additional Information:
Study ID Numbers: CDR0000068868; CTSU,RTOG-P-0011,CAN-NCIC-PR9,RTOG-DEV-1037
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023829
Other Stage 3 Prostate Cancer Studies:
1. Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
2. APC8015 and Bevacizumab in Treating Patients With Prostate Cancer
3. Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
4. Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer
5. Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer
Related Studies:
Other stage 3 prostate cancer Clinical Trials
Other Wisconsin Clinical Trials
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Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
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