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| ID | Type | Description | Link |
|---|---|---|---|
| ACOSOG-Z0070 | |||
| CDR0000068851 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer.
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.
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery | Experimental | Patients undergo radical prostatectomy. Patients are followed every 6 months for 5 years and then annually thereafter. |
|
| radiation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgery | Procedure |
| ||
| radiation |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival | Up to 10 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate within the past 120 days
No bilateral disease
Prostate-specific antigen (PSA) no greater than 10 ng/mL
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:
Performance status:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Endocrine therapy:
See Disease Characteristics
At least 90 days since prior NHT
No concurrent NHT
Radiotherapy:
Surgery:
No prior surgery for prostate cancer or benign disease, including:
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| Name | Affiliation | Role |
|---|---|---|
| Paul H. Lange, MD | University of Washington | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent Cancer Center | Little Rock | Arkansas | 72205-5499 | United States | ||
| UCSF Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 16943531 | Background | 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. | |
| 21149658 |
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|
| San Francisco |
| California |
| 94143-0128 |
| United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612-9497 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62794-9230 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1062 | United States |
| Kansas Cancer Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Northeast Heights Cancer Center | Albuquerque | New Mexico | 87109 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1082 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Wellspan Health - York Cancer Center | York | Pennsylvania | 17403 | United States |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee | 37232-6838 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Wilford Hall Medical Center | Lackland Air Force Base | Texas | 78236-5300 | United States |
| American Fork Hospital | American Fork | Utah | 84003 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| Fletcher Allen Health Care - Medical Center Campus | Burlington | Vermont | 05401 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Veterans Affairs Medical Center - Richmond | Richmond | Virginia | 23249 | United States |
| Veterans Affairs Medical Center - Seattle | Seattle | Washington | 98108 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431-5048 | United States |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 355 | Canada |
| Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| Cancer Care Ontario-London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Result |
| 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. |
| Result | 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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