Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer
NCT ID: NCT00023686
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
190 participants
INTERVENTIONAL
2001-10-31
2004-04-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.
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Detailed Description
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* Compare overall survival in patients with stage II prostate cancer treated with radical prostatectomy vs brachytherapy.
* Compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens.
* Compare the side effects of these treatment regimens in these patients.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
* Arm I: Patients undergo radical prostatectomy.
* Arm II: Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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surgery
Patients undergo radical prostatectomy.
Patients are followed every 6 months for 5 years and then annually thereafter.
surgery
radiation
Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds.
Patients are followed every 6 months for 5 years and then annually thereafter.
radiation
Interventions
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surgery
radiation
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of the prostate within the past 120 days
* T1c-T2a, N0, M0
* No bilateral disease
* Prostate-specific antigen (PSA) no greater than 10 ng/mL
* In patients with prior neoadjuvant hormonal therapy (NHT), PSA must be less than 10 ng/mL prior to therapy
* Gleason score no greater than 6
* Prostate gland less than 60 cc on transrectal ultrasound or with minimal pubic arch interference OR
* Prostate gland 60 cc or greater prior to NHT allowed if prostate size has been reduced to less than 60 cc by NHT
PATIENT CHARACTERISTICS:
Age:
* 75 and under
Performance status:
* ECOG 0-2 OR
* Zubrod 0-2
Renal:
* Creatinine no greater than 3 mg/dL
Cardiovascular:
* No significant cardiovascular disease
* No New York Heart Association class III or IV heart disease
Other:
* No other malignancy within the past 5 years except effectively treated basal cell or squamous cell skin cancer or other malignancy at low risk for recurrence
* No other condition that would preclude study
PRIOR CONCURRENT THERAPY:
Endocrine therapy:
* See Disease Characteristics
* At least 90 days since prior NHT
* Duration of therapy no greater than 120 days
* No concurrent NHT
Radiotherapy:
* No prior radiotherapy to pelvis
Surgery:
* No prior surgery for prostate cancer or benign disease, including:
* Transurethral resection of the prostate
* Transurethral resection of the bladder neck
* Cryotherapy
* Laser ablation
* Microwave therapy
75 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Paul H. Lange, MD
Role: STUDY_CHAIR
University of Washington
Locations
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St. Vincent Cancer Center
Little Rock, Arkansas, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Kansas Cancer Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Northeast Heights Cancer Center
Albuquerque, New Mexico, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Wellspan Health - York Cancer Center
York, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
American Fork Hospital
American Fork, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Countries
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References
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Crook J, Wallace K, Jewett M, et al.: Enhancing enrollment in difficult randomized trials: the profile of men accepting randomization to SPIRIT (surgical prostatectomy vs interstitial radiation). [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-295, 2006.
Wallace K, Fleshner N, Jewett M, Basiuk J, Crook J. Impact of a multi-disciplinary patient education session on accrual to a difficult clinical trial: the Toronto experience with the surgical prostatectomy versus interstitial radiation intervention trial. J Clin Oncol. 2006 Sep 1;24(25):4158-62. doi: 10.1200/JCO.2006.06.3875.
Crook JM, Gomez-Iturriaga A, Wallace K, Ma C, Fung S, Alibhai S, Jewett M, Fleshner N. Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial. J Clin Oncol. 2011 Feb 1;29(4):362-8. doi: 10.1200/JCO.2010.31.7305. Epub 2010 Dec 13.
Crook JM, Gomez-Iturriaga A, Wallace K, et al.: Comparison of health-related quality of life 5 years after SPIRIT (Surgical Prostatectomy [RP] versus Interstitial Radiation [BT] Intervention trial ACOSOG Z0070). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-11, 2010.
Other Identifiers
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ACOSOG-Z0070
Identifier Type: -
Identifier Source: secondary_id
CDR0000068851
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z0070
Identifier Type: -
Identifier Source: org_study_id
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