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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000462375 | |||
| NCI-2009-00728 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to risk group.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Androgen suppression + Radiation Therapy | Active Comparator | Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of radiation therapy (RT). |
|
| Androgen suppression + Radiation Therapy + Chemotherapy | Experimental | Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Premedication of dexamethasone prior to docetaxel, per institutional standards. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Control | Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. |
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DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer at high-risk for recurrence within the past 180 days as determined by 1 of the following combinations (risk groups):
Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal sampling, or dissection within 90 days prior to study entry
PSA ≤ 150 ng/mL
Cannot have been obtained during any of the following time points:
No distant metastases by physical exam and bone scan
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for prostatic hypertrophy
At least 90 days since prior testosterone
Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen ablation was initiated no more than 50 days prior to study entry
No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy
No prior systemic chemotherapy for prostate cancer
No prior radiotherapy, including brachytherapy, to the region of prostate cancer that would result in overlap of radiotherapy fields
Intensity modulated radiotherapy allowed
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| Name | Affiliation | Role |
|---|---|---|
| Howard M. Sandler, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Seth Rosenthal, MD | Radiological Associates of Sacramento Medical Group at Sutter Cancer Center | Study Chair |
| Mahul Amin, MD | Cedars-Sinai Medical Center | Study Chair |
| Leonard G. Gomella, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Study Chair |
| James Purdy, PhD | University of California, Davis | Study Chair |
| Jeff Michalski, MD | Washington University School of Medicine | Study Chair |
| Mark Garzotto, MD | Portland VA Medical Center | Study Chair |
| Oliver Sartor, MD | Tulane School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| Providence Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16425991 | Result | Patel AR, Sandler HM, Pienta KJ. Radiation Therapy Oncology Group 0521: a phase III randomized trial of androgen suppression and radiation therapy versus androgen suppression and radiation therapy followed by chemotherapy with docetaxel/prednisone for localized, high-risk prostate cancer. Clin Genitourin Cancer. 2005 Dec;4(3):212-4. doi: 10.3816/cgc.2005.n.035. No abstract available. | |
| 40675873 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| NCT00288080 | Individual Participant Data Set | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Androgen Suppression + Radiation Therapy (RT) | Androgen suppression (AS; luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Prednisone | Drug | 10 mg orally per day until day 21 of the last cycle of docetaxel, beginning 28 days after the completion of RT. |
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| docetaxel | Drug | 75 mg/m2 i.v. over 1 hour (on day 1 of each cycle) every 21 days for 6 cycles, beginning 28 days after the completion of RT. |
|
| Oral antiandrogen | Drug | Oral antiandrogen of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy. Treatment is discontinued at the end of radiation therapy. |
|
| Radiation therapy | Radiation | 46.8 Gy, using either three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT), will be given to the regional lymphatics followed by a 25.2-28.8 Gy boost to the prostate, to bring the total dose to the prostate to 72.0-75.6 Gy. Daily prescription doses will be 1.8 Gy per day, 5 days per week x 8-8.5 weeks, beginning 8 weeks after the initiation of androgen suppression. |
|
|
| LHRH agonist | Drug | LHRH agonist of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy, and then until 24 months from initiation of any treatment has been reached. |
|
| From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
| Local Control | Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method. | From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
| Distant Metastasis | Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method. | From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
| Disease-free Survival | A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method. | From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
| Incidence of Adverse Events | Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted. | From start of treatment until the end of follow-up |
| The Time Interval Between Biochemical Failure and Distant Failure Respect to Testosterone Level | Biochemical failure is defined as the first of either prostate-specific antigen (PSA) failure or the initiation of salvage hormone therapy. PSA failure is defined as a rise in PSA of 2 ng/ml over the nadir PSA. Distant failure is defined as the first occurrence of distant metastasis. | From date of biochemical failure to development of distant metastasis. Maximum follow-up was 12.9 years. |
| Validity of PSA Endpoint as a Surrogate for Overall Survival | Prentice's operational criteria for determining whether determining whether biochemical failure (surrogate endpoint) is a suitable endpoint for overall survival (true endpoint):
If any of the criteria are not met, it is concluded that biochemical failure is not a suitable surrogate for overall survival. Therefore, if any of the criteria are met, the other criteria do not do not need to be evaluated. | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
| Anchorage |
| Alaska |
| 99508 |
| United States |
| Arizona Oncology Services Foundation | Phoenix | Arizona | 85013 | United States |
| Arizona Oncology - Tucson | Tucson | Arizona | 85704 | United States |
| Auburn Radiation Oncology | Auburn | California | 95603 | United States |
| Providence Saint Joseph Medical Center - Burbank | Burbank | California | 91505 | United States |
| Radiation Oncology Centers - Cameron Park | Cameron Park | California | 95682 | United States |
| Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael | California | 95608 | United States |
| Enloe Cancer Center at Enloe Medical Center | Chico | California | 95926 | United States |
| Cancer Care Center at John Muir Health - Concord Campus | Concord | California | 94524-4110 | United States |
| Washington Township Hospital | Fremont | California | 94538 | United States |
| Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital | Grass Valley | California | 95945 | United States |
| Rebecca and John Moores UCSD Cancer Center | La Jolla | California | 92093-0658 | United States |
| Memorial Medical Center | Modesto | California | 95355 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center | Rancho Mirage | California | 92270 | United States |
| Radiation Oncology Center - Roseville | Roseville | California | 95661 | United States |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento | California | 95815 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| California Pacific Medical Center - California Campus | San Francisco | California | 94118 | United States |
| Torrance Memorial Medical Center | Torrance | California | 90509 | United States |
| Solano Radiation Oncology Center | Vacaville | California | 95687 | United States |
| John Muir/Mt. Diablo Comprehensive Cancer Center | Walnut Creek | California | 94598 | United States |
| Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado | 80012 | United States |
| University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Swedish Medical Center | Englewood | Colorado | 80110 | United States |
| Poudre Valley Radiation Oncology | Fort Collins | Colorado | 80528 | United States |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | 81502 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| McKee Medical Center | Loveland | Colorado | 80539 | United States |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| St. Vincent's Medical Center | Bridgeport | Connecticut | 06606 | United States |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States |
| Hospital of Saint Raphael | New Haven | Connecticut | 06511 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06520-8028 | United States |
| Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut | 06360 | United States |
| William W. Backus Hospital | Norwich | Connecticut | 06360 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | United States |
| Bay Medical | Panama City | Florida | 32401 | United States |
| Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| John B. Amos Cancer Center | Columbus | Georgia | 31904 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | United States |
| Northwest Community Hospital | Arlington Heights | Illinois | 60005 | United States |
| Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | 62526 | United States |
| Elmhurst Memorial Hospital | Elmhurst | Illinois | 60126 | United States |
| Advocate Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068-1174 | United States |
| Center for Cancer Care at OSF Saint Anthony Medical Center | Rockford | Illinois | 61108 | United States |
| Cancer Institute at St. John's Hospital | Springfield | Illinois | 62702 | United States |
| Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | 62781-0001 | United States |
| Saint John's Cancer Center at Saint John's Medical Center | Anderson | Indiana | 46016 | United States |
| Radiation Oncology Associates Southwest | Fort Wayne | Indiana | 46804 | United States |
| Parkview Regional Cancer Center at Parkview Health | Fort Wayne | Indiana | 46805 | United States |
| Veterans Affairs Medical Center - Indianapolis | Indianapolis | Indiana | 46202 | United States |
| Central Indiana Cancer Centers - East | Indianapolis | Indiana | 46219 | United States |
| McFarland Clinic, PC | Ames | Iowa | 50010 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| Kansas City Cancer Centers - Southwest | Overland Park | Kansas | 66210 | United States |
| Norton Suburban Hospital | Louisville | Kentucky | 40207 | United States |
| Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | 71315-3198 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough | Maine | 04074 | United States |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| St. Agnes Hospital Cancer Center | Baltimore | Maryland | 21229 | United States |
| Suburban Hospital | Bethesda | Maryland | 20814 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River | Massachusetts | 02721 | United States |
| Shields Radiation Oncology Center - Mansfield | Mansfield | Massachusetts | 02048 | United States |
| NSMC Cancer Center - Peabody | Peabody | Massachusetts | 01960 | United States |
| South Suburban Oncology Center | Quincy | Massachusetts | 02169 | United States |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan | 48910 | United States |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | 48073 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| St. Luke's Hospital Cancer Care Center | Duluth | Minnesota | 55805 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi | 39581 | United States |
| Cancer Institute of Cape Girardeau, LLC | Cape Girardeau | Missouri | 63703 | United States |
| St. John's Regional Medical Center | Joplin | Missouri | 64804 | United States |
| Kansas City Cancer Centers - South | Kansas City | Missouri | 64131 | United States |
| Kansas City Cancer Centers - North | Kansas City | Missouri | 64154 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| David C. Pratt Cancer Center at St. John's Mercy | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | United States |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| Immanuel Medical Center | Omaha | Nebraska | 68122 | United States |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131-2197 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | United States |
| Dartmouth - Hitchcock Concord | Concord | New Hampshire | 03301 | United States |
| Seacoast Cancer Center at Wentworth - Douglass Hospital | Dover | New Hampshire | 03820 | United States |
| Center for Cancer Care at Exeter Hospital | Exeter | New Hampshire | 03833 | United States |
| Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene | New Hampshire | 03431 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Elliot Regional Cancer Center at Elliot Hospital | Manchester | New Hampshire | 03103 | United States |
| Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden | New Jersey | 08103 | United States |
| CentraState Medical Center | Freehold | New Jersey | 07728 | United States |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey | 08053 | United States |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Lovelace Medical Center - Downtown | Albuquerque | New Mexico | 87102 | United States |
| New Mexico Cancer Center | Albuquerque | New Mexico | 87109 | United States |
| Radiation Oncology Associates, PA | Albuquerque | New Mexico | 87109 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-5636 | United States |
| Cancer Institute of New Mexico | Santa Fe | New Mexico | 87505 | United States |
| New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany | New York | 12206 | United States |
| Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital | Cooperstown | New York | 13326 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Veterans Affairs Medical Center - Syracuse | Syracuse | New York | 13210 | United States |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| CaroMont Cancer Center at Gaston Memorial Hospital | Gastonia | North Carolina | 28053 | United States |
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina | 27834 | United States |
| High Point Regional Hospital | High Point | North Carolina | 27261 | United States |
| New Hanover Radiation Oncology, PA | Wilmington | North Carolina | 28401 | United States |
| Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Barberton Citizens Hospital | Barberton | Ohio | 44203 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Cleveland Clinic Cancer Center | Independence | Ohio | 44131 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Lima Memorial Hospital | Lima | Ohio | 45804 | United States |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43537-1839 | United States |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | United States |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | United States |
| Cancer Care Center, Incorporated | Salem | Ohio | 44460 | United States |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43617 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Cleveland Clinic - Wooster | Wooster | Ohio | 44691 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | 74136 | United States |
| Willamette Valley Cancer Center - Eugene | Eugene | Oregon | 97401 | United States |
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| Salem Hospital Regional Cancer Care Services | Salem | Oregon | 97309-5014 | United States |
| Celilo Cancer Center at Mid-Columbia Medical Center | The Dalles | Oregon | 97058 | United States |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| UPMC Cancer Center at Beaver Medical Center | Beaver | Pennsylvania | 15009 | United States |
| UPMC Cancer Center at Jefferson Regional Medical Center | Clairton | Pennsylvania | 15025 | United States |
| Cancer Center at Clarion Hospital | Clarion | Pennsylvania | 16214 | United States |
| Mercy Fitzgerald Hospital | Darby | Pennsylvania | 19023 | United States |
| Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| Northeast Radiation Oncology Center | Dunmore | Pennsylvania | 18512 | United States |
| UPMC Cancer Center - Arnold Palmer Pavilion | Greensburg | Pennsylvania | 15601 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| UPMC Cancer Center at the John P. Murtha Pavilion | Johnstown | Pennsylvania | 15901 | United States |
| UPMC Cancer Center at UPMC McKeesport | McKeesport | Pennsylvania | 15132 | United States |
| UPMC - Moon | Moon Township | Pennsylvania | 15108 | United States |
| UPMC Cancer Center - Natrona Heights | Natrona Heights | Pennsylvania | 15065 | United States |
| Jameson Memorial Hospital - North Campus | New Castle | Pennsylvania | 16105 | United States |
| Cancer Center of Paoli Memorial Hospital | Paoli | Pennsylvania | 19301-1792 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | United States |
| UPMC - Shadyside | Pittsburgh | Pennsylvania | 15213-2582 | United States |
| UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Cancer Center at UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Cancer Center at UPMC St. Margaret | Pittsburgh | Pennsylvania | 15215 | United States |
| UPMC Cancer Center at UPMC Passavant | Pittsburgh | Pennsylvania | 15237 | United States |
| UPMC Cancer Center - Upper St. Clair | Pittsburgh | Pennsylvania | 15243 | United States |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania | 19612-6052 | United States |
| Guthrie Cancer Center at Guthrie Clinic Sayre | Sayre | Pennsylvania | 18840 | United States |
| Grand View Hospital | Sellersville | Pennsylvania | 18960 | United States |
| UPMC Cancer Center at UPMC Northwest | Seneca | Pennsylvania | 16346 | United States |
| UPMC Cancer Center - Uniontown | Uniontown | Pennsylvania | 15401 | United States |
| Washington Hospital Cancer Center | Washington | Pennsylvania | 15301 | United States |
| CCOP - Main Line Health | Wynnewood | Pennsylvania | 19096 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| York Cancer Center at Apple Hill Medical Center | York | Pennsylvania | 17405 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916 | United States |
| Texas Oncology, PA at Harris Center HEB | Bedford | Texas | 76022 | United States |
| St. Joseph Regional Cancer Center | Bryan | Texas | 77802 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| Texas Oncology, PA at Texas Cancer Center Dallas Southwest | Dallas | Texas | 75237 | United States |
| Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital | Fort Worth | Texas | 76104 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Texas Oncology, PA at Texas Cancer Center - Sherman | Sherman | Texas | 75090 | United States |
| Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land | Sugar Land | Texas | 77479 | United States |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah | 84157 | United States |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| Community Cancer Center at Rutland Regional Medical Center | Rutland | Vermont | 05701 | United States |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| Veterans Affairs Medical Center - Richmond | Richmond | Virginia | 23249 | United States |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405 | United States |
| Madigan Army Medical Center - Tacoma | Tacoma | Washington | 98431 | United States |
| West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia | 25304 | United States |
| Theda Care Cancer Institute | Appleton | Wisconsin | 54911 | United States |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54301-3526 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin | 54601 | United States |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Community Memorial Hospital Cancer Care Center | Menomonee Falls | Wisconsin | 53051 | United States |
| Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin | 53097 | United States |
| Columbia-Saint Mary's Cancer Care Center | Milwaukee | Wisconsin | 53211 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee | Wisconsin | 53295 | United States |
| Vince Lombardi Cancer Clinic - Sheboygan | Sheboygan | Wisconsin | 53081 | United States |
| University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau | Wisconsin | 54401 | United States |
| Tom Baker Cancer Centre - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute at University of Alberta | Edmonton | Alberta | T6G 1Z2 | Canada |
| Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| London Regional Cancer Program at London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario | K1Y 4K7 | Canada |
| Hopital Notre-Dame du CHUM | Montreal | Quebec | H2L 4M1 | Canada |
| McGill Cancer Centre at McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan | S4T 7T1 | Canada |
| Derived |
| Phillips RM, Proudfoot JA, Davicioni E, Liu Y, Spratt DE, Simko JM, Den RB, Pollack A, Rosenthal SA, Sartor AO, Sweeney CJ, Attard G, Longoria L, Patel S, Straza MW, Efstathiou JA, Shah AB, Hoffman KE, Rodgers JP, Sandler HM, Feng FY, Tran PT. Transcriptomic Analysis of Localized High-risk Prostate Cancer Improves Prognostication and Identifies Benefit from Adding Docetaxel to Definitive Radiotherapy with Androgen Suppression in the NRG Oncology/RTOG 0521 Phase 3 Trial. Eur Urol Oncol. 2025 Aug;8(4):968-976. doi: 10.1016/j.euo.2025.04.009. Epub 2025 Jul 17. |
| 39660731 | Derived | Flannery BT, Sandler HM, Lal P, Feldman MD, Santa-Rosario JC, Pathak T, Mirtti T, Farre X, Correa R, Chafe S, Shah A, Efstathiou JA, Hoffman K, Hallman MA, Straza M, Jordan R, Pugh SL, Feng F, Madabhushi A. Stress testing deep learning models for prostate cancer detection on biopsies and surgical specimens. J Pathol. 2025 Feb;265(2):146-157. doi: 10.1002/path.6373. Epub 2024 Dec 11. |
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive |
| Androgen Suppression + Radiation Therapy + Chemotherapy |
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible patients who have not withdrawn consent.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Androgen Suppression + Radiation Therapy | Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. |
| BG001 | Androgen Suppression + Radiation Therapy + Chemotherapy | Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. | Eligible patients who did not withdraw consent. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Biochemical Control | Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. | Eligible patients who did not withdraw consent. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Local Control | Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method. | Eligible patients who did not withdraw consent | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Distant Metastasis | Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method. | Eligible patients who did not withdraw consent. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease-free Survival | A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method. | Eligible patients who did not withdraw consent. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events | Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted. | Eligible patients who started protocol treatment and did not withdraw consent | Posted | Number | percentage of participants | From start of treatment until the end of follow-up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Time Interval Between Biochemical Failure and Distant Failure Respect to Testosterone Level | Biochemical failure is defined as the first of either prostate-specific antigen (PSA) failure or the initiation of salvage hormone therapy. PSA failure is defined as a rise in PSA of 2 ng/ml over the nadir PSA. Distant failure is defined as the first occurrence of distant metastasis. | The analysis will not be done because testosterone measurement dates were not collected. | Posted | From date of biochemical failure to development of distant metastasis. Maximum follow-up was 12.9 years. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Validity of PSA Endpoint as a Surrogate for Overall Survival | Prentice's operational criteria for determining whether determining whether biochemical failure (surrogate endpoint) is a suitable endpoint for overall survival (true endpoint):
If any of the criteria are not met, it is concluded that biochemical failure is not a suitable surrogate for overall survival. Therefore, if any of the criteria are met, the other criteria do not do not need to be evaluated. | Because the second criterion is not met, further analysis was not performed. | Posted | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. |
|
Not provided
Participants who started protocol treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Androgen Suppression + Radiation Therapy | Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. | 26 | 302 | 278 | 302 | ||
| EG001 | Androgen Suppression + Radiation Therapy + Chemotherapy | Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression. | 93 | 302 | 289 | 302 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac general - Other | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myocarditis NOS | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ventricular arrhythmia NOS | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colitis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colonic hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastritis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal - Other | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pancreatitis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: limb | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sudden death | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syndromes - Other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypersensitivity NOS | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder infection NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection - Other | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Brain + Spinal cord (encephalomyelitis) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC: Skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Kidney infection NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonia NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary tract infection NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fracture NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vascular access NOS complication | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypercholesterolemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Metabolic/laboratory - Other | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Troponin I increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle weakness NOS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal/soft tissue - Other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Secondary Malignancy - possibly related to cancer treatment | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cerebral ischemia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neurology - Other | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Euphoric mood | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cystitis NOS | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal failure NOS | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ejaculatory disorder NOS | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erectile dysfunction NOS | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pulmonary/upper respiratory - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatology/skin - Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Localised exfoliation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sweating increased | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot flushes NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral ischemia | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/bone marrow - Other | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal - Other | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctitis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: limb | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Metabolic/laboratory - Other | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle weakness NOS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal/soft tissue - Other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cystitis NOS | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal/genitourinary - Other | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urogenital hemorrhage | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ejaculatory disorder NOS | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erectile dysfunction NOS | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatology/skin - Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nail disorder NOS | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sweating increased | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot flushes NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Due to insufficient number of events, local control analysis was not conducted.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld, M.S. | NRG Oncology | seiferheldw@nrgoncology.org |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D011241 | Prednisone |
| D000077143 | Docetaxel |
| D000726 | Androgen Antagonists |
| D011878 | Radiotherapy |
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011244 | Pregnadienediols |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D013812 | Therapeutics |
| D011881 | Radiotherapy, Computer-Assisted |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Male |
|
|
|
|
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
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| Participants |
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