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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000069306 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score and prostate-specific antigen (PSA) level (Gleason score 2-6, PSA ≥10 mg/mL but < 20 ng/mL vs Gleason score 7, PSA < 15 ng/mL) and radiation modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms.
Quality of life (QOL) is assessed initially at baseline. After completion of radiotherapy, QOL is assessed every 3 months for 1 year and then every 6 months for 4 years.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,520 patients (760 per treatment arm) will be accrued for this study within 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 70.2 Gy | Active Comparator | 70.2 Gy 3D-CRT/IMRT |
|
| 79.2 Gy | Experimental | 79.2 Gy 3D-CRT/IMRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 70.2 Gy 3D-CRT/IMRT | Radiation | Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact. | From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition | Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact. |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Meets one of the following criteria:
No regional lymph node involvement
No distant metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
At least 3 months since prior finasteride
No other prior hormonal therapy, including:
No concurrent (neoadjuvant or adjuvant) hormonal therapy
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff M. Michalski, MD | Washington University - Saint Louis | Principal Investigator |
| James Purdy, Ph.D. | UC Davis | Study Chair |
| Deborah W Bruner, Ph.D. | Emory University | Study Chair |
| Mahul Amin, M.D. | Cedars-Sinai | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Long Beach | Long Beach | California | 90822 | United States | ||
| Radiological Associates of Sacramento Medical Group, Incorporated |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18674684 | Background | Cranmer-Sargison G. A treatment planning investigation into the dosimetric effects of systematic prostate patient rotational set-up errors. Med Dosim. 2008 Autumn;33(3):199-205. doi: 10.1016/j.meddos.2007.06.005. | |
| 17825932 | Result | Potrebko PS, McCurdy BM, Butler JB, El-Gubtan AS, Nugent Z. Optimal starting gantry angles using equiangular-spaced beams with intensity modulated radiation therapy for prostate cancer on RTOG 0126: a clinical study of 5 and 7 fields. Radiother Oncol. 2007 Nov;85(2):299-305. doi: 10.1016/j.radonc.2007.06.019. Epub 2007 Sep 7. |
| Label | URL |
|---|---|
| Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 70.2 Gy | 70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| 79.2 Gy 3D-CRT/IMRT | Radiation | Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy. |
|
|
| From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years. |
| Disease Specific Survival | Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy. | From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint. |
| Local Progression | Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. | From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. |
| Distant Metastases | Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. | From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. |
| Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity | Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0 | From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint |
| Percentage of Participants With Erectile Disfuction at 12 Months | The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 ("How often were you able to get an erection during sexual activity?") is scored from: none/almost never (response 0-1) or < half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction. | Twelve months from randomization |
| Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months | The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change >= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM < change < SEM; Declined: when change <= SEM. | Baseline and 12 months from randomization |
| Quality Adjusted Survival by SQLI | From randomization to 5 years. |
| Tumor Control Probability | From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis. |
| Normal Tissue Complication Probability | From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis. |
| Sacramento |
| California |
| 95815 |
| United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Washington Cancer Institute at Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Bay Medical | Panama City | Florida | 32401 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| Oncology Center at Saint Margaret Mercy Healthcare Center | Hammond | Indiana | 46320 | United States |
| Cancer Center at Ball Memorial Hospital | Muncie | Indiana | 47303-3499 | United States |
| Providence Medical Center | Kansas City | Kansas | 66112 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| Johnson County Radiation Therapy | Overland Park | Kansas | 66210 | United States |
| Shawnee Mission Medical Center | Shawnee Mission | Kansas | 66204 | United States |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Central Maryland Oncology Center | Columbia | Maryland | 21044 | United States |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | 48105 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| Foote Memorial Hospital | Jackson | Michigan | 49201 | 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 |
| CentraCare Clinic - River Campus | Saint Cloud | Minnesota | 56303 | United States |
| Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi | 39581 | United States |
| Independence Regional Health Center | Independence | Missouri | 64050 | United States |
| Truman Medical Center - Hospital Hill | Kansas City | Missouri | 64108 | United States |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Kansas City Cancer Center at St. Joseph's Medical Mall | Kansas City | Missouri | 64114 | United States |
| St. Joseph Medical Center | Kansas City | Missouri | 64114 | United States |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | United States |
| Parvin Radiation Oncology | Kansas City | Missouri | 64116 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center | Kansas City | Missouri | 64154 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| Saint Mary's Regional Medical Center | Reno | Nevada | 89503 | United States |
| Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden | New Jersey | 08103 | 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 |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York | 11209 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Cancer Centers of North Carolina - Raleigh | Raleigh | North Carolina | 27607 | United States |
| Rex Cancer Center at Rex Hospital | Raleigh | North Carolina | 27607 | United States |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | United States |
| Precision Radiotherapy at University Pointe | West Chester | Ohio | 45069 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | 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 |
| MNAP Oncologic Center | Philadelphia | Pennsylvania | 19115 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania | 19612-6052 | United States |
| Mount Nittany Medical Center | State College | Pennsylvania | 16803 | United States |
| CCOP - Main Line Health | Wynnewood | Pennsylvania | 19096 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234-6200 | United States |
| Wilford Hall Medical Center | Lackland Air Force Base | Texas | 78236 | 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 |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Community Memorial Hospital Cancer Care Center | Menomonee Falls | Wisconsin | 53051 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine | Wisconsin | 53405 | United States |
| Tom Baker Cancer Centre - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute at University of Alberta | Edmonton | Alberta | T6G 1Z2 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| Doctor H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Northeastern Ontario Regional Cancer Centre | Greater Sudbury | Ontario | P3E 5J1 | 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 |
| Cancer Care Program at Thunder Bay Regional Health Sciences | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Edmond Odette Cancer Centre at Sunnybrook | Toronto | Ontario | M4N 3M5 | 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 |
| Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| 38320143 | Derived | Spratt DE, Tang S, Sun Y, Huang HC, Chen E, Mohamad O, Armstrong AJ, Tward JD, Nguyen PL, Lang JM, Zhang J, Mitani A, Simko JP, DeVries S, van der Wal D, Pinckaers H, Monson JM, Campbell HA, Wallace J, Ferguson MJ, Bahary JP, Schaeffer EM, Sandler HM, Tran PT, Rodgers JP, Esteva A, Yamashita R, Feng FY. Artificial Intelligence Predictive Model for Hormone Therapy Use in Prostate Cancer. NEJM Evid. 2023 Aug;2(8):EVIDoa2300023. doi: 10.1056/EVIDoa2300023. Epub 2023 Jun 29. |
| 37751207 | Derived | Alexander GS, Krc RF, Assif JW, Sun K, Molitoris JK, Tran P, Rana Z, Bentzen SM, Mishra MV. Conditional Risks of Biochemical Failure and Prostate Cancer-Specific Death in Patients Undergoing External Beam Radiotherapy: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2023 Sep 5;6(9):e2335069. doi: 10.1001/jamanetworkopen.2023.35069. |
| 37137444 | Derived | Spratt DE, Liu VYT, Michalski J, Davicioni E, Berlin A, Simko JP, Efstathiou JA, Tran PT, Sandler HM, Hall WA, Thompson DJS, Parliament MB, Dayes IS, Correa RJM, Robertson JM, Gore EM, Doncals DE, Vigneault E, Souhami L, Karrison TG, Feng FY. Genomic Classifier Performance in Intermediate-Risk Prostate Cancer: Results From NRG Oncology/RTOG 0126 Randomized Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):370-377. doi: 10.1016/j.ijrobp.2023.04.010. Epub 2023 May 2. |
| 36884035 | Derived | Kim S, Kong JH, Lee Y, Lee JY, Kang TW, Kong TH, Kim MH, You SH. Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD012817. doi: 10.1002/14651858.CD012817.pub2. |
| 29543933 | Derived | Michalski JM, Moughan J, Purdy J, Bosch W, Bruner DW, Bahary JP, Lau H, Duclos M, Parliament M, Morton G, Hamstra D, Seider M, Lock MI, Patel M, Gay H, Vigneault E, Winter K, Sandler H. Effect of Standard vs Dose-Escalated Radiation Therapy for Patients With Intermediate-Risk Prostate Cancer: The NRG Oncology RTOG 0126 Randomized Clinical Trial. JAMA Oncol. 2018 Jun 14;4(6):e180039. doi: 10.1001/jamaoncol.2018.0039. Epub 2018 Jun 14. |
| FG001 | 79.2 Gy | 79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All eligible patients who did not withdraw consent
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 70.2 Gy | 70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy. |
| BG001 | 79.2 Gy | 79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy. |
| 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 | Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact. | All eligible patients who did not withdraw consent | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years. |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition | Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact. | All eligible patients who did not withdraw consent | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years. |
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| Secondary | Disease Specific Survival | Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy. | All eligible patients who did not withdraw consent | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint. |
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| Secondary | Local Progression | Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. | All eligible patients who have not withdrawn consent | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. |
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| Secondary | Distant Metastases | Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. | All eligible patients who have not withdrawn consent | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. |
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| Secondary | Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity | Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0 | Eligible patients with acute adverse event data who did not withdraw consent. | Posted | Number | percentage of participants | From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint |
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| Secondary | Percentage of Participants With Erectile Disfuction at 12 Months | The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 ("How often were you able to get an erection during sexual activity?") is scored from: none/almost never (response 0-1) or < half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction. | Eligible patients with a response of 4 or 5 (most times/almost always/always) to IIEF question 1 at baseline | Posted | Number | 95% Confidence Interval | percentage of participants | Twelve months from randomization |
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| Secondary | Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months | The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change >= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM < change < SEM; Declined: when change <= SEM. | Eligible participants with baseline and 12 month SQLI | Posted | Count of Participants | Participants | Baseline and 12 months from randomization |
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| Secondary | Quality Adjusted Survival by SQLI | This analysis will not be done because we are unable to find the required algorithm for converting SQLI scores into utilities, which is needed for quality adjusted survival analysis. | Posted | From randomization to 5 years. |
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| Secondary | Tumor Control Probability | Not Posted | Dec 2023 | From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Normal Tissue Complication Probability | Not Posted | Dec 2023 | From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis. | Participants |
Not provided
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
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 | 70.2 Gy | 70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy. | 30 | 744 | 714 | 744 | ||
| EG001 | 79.2 Gy | 79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 44 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy. | 43 | 737 | 704 | 737 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left ventricular failure | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Diarrhea (with colostomy) | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bowel : NOS | Gastrointestinal disorders | CTC (2.0) | Systematic Assessment |
| |
| Late RT Toxicity: Other GI : NOS | Gastrointestinal disorders | CTC (2.0) | Systematic Assessment |
| |
| Chest pain | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Injection site reaction NOS | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other : NOS | General disorders | CTC (2.0) | Systematic Assessment |
| |
| Pain due to radiation | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pain-other | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bladder/Other GU: NOS | Renal and urinary disorders | CTC (2.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTC (2.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dyspnea NOS | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Skin-Other | Skin and subcutaneous tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hemorrhage-Other | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bowel : NOS | Gastrointestinal disorders | CTC (2.0) | Systematic Assessment |
| |
| Late RT Toxicity: Other GI : NOS | Gastrointestinal disorders | CTC (2.0) | Systematic Assessment |
| |
| Proctitis NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other : NOS | General disorders | CTC (2.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bladder/Other GU: NOS | Renal and urinary disorders | CTC (2.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTC (2.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTC (2.0) | Systematic Assessment |
| |
| Impotence | Reproductive system and breast disorders | CTC (2.0) | Systematic Assessment |
|
The data monitoring committee (DMC) recommended early reporting of the trial when the third interim analysis futility boundary was crossed.
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 |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
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|
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
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