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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

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5. Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer

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