Radiation Therapy in Treating Patients With Stage II Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Radiation: 70.2 Gy 3D-CRT/IMRTRadiation: 79.2 Gy 3D-CRT/IMRT
- Registration Number
- NCT00033631
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy.
* Compare the freedom from prostate-specific antigen failure, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
* Compare the probability of tumor control and normal tissue complications in patients treated with these regimens.
* Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens.
* Compare the quality of life, including sexual function, of patients treated with these regimens.
* Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens.
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.
* Arm I: Patients undergo standard-dose 3D-CRT or IMRT once daily, 5 days a week, for 7.8 weeks (39 treatment days).
* Arm II: Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days).
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1534
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 70.2 Gy 70.2 Gy 3D-CRT/IMRT 70.2 Gy 3D-CRT/IMRT 79.2 Gy 79.2 Gy 3D-CRT/IMRT 79.2 Gy 3D-CRT/IMRT
- Primary Outcome Measures
Name Time Method Overall Survival From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years. 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.
- Secondary Outcome Measures
Name Time Method Quality Adjusted Survival by SQLI From randomization to 5 years. Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition 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. 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.
Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months Baseline and 12 months from randomization 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.Normal Tissue Complication Probability From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis. Disease Specific Survival 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. 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.
Local Progression From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. 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.
Distant Metastases From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. 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.
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. Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0
Percentage of Participants With Erectile Disfuction at 12 Months Twelve months from randomization 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.
Trial Locations
- Locations (86)
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Washington Cancer Institute at Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Bay Medical
🇺🇸Panama City, Florida, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Oncology Center at Saint Margaret Mercy Healthcare Center
🇺🇸Hammond, Indiana, United States
Cancer Center at Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Central Maryland Oncology Center
🇺🇸Columbia, Maryland, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
CentraCare Clinic - River Campus
🇺🇸Saint Cloud, Minnesota, United States
Regional Cancer Center at Singing River Hospital
🇺🇸Pascagoula, Mississippi, United States
Independence Regional Health Center
🇺🇸Independence, Missouri, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Saint Mary's Regional Medical Center
🇺🇸Reno, Nevada, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden
🇺🇸Camden, New Jersey, United States
Veterans Affairs Medical Center - Brooklyn
🇺🇸Brooklyn, New York, United States
Lovelace Medical Center - Downtown
🇺🇸Albuquerque, New Mexico, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Cancer Centers of North Carolina - Raleigh
🇺🇸Raleigh, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital
🇺🇸Akron, Ohio, United States
Rex Cancer Center at Rex Hospital
🇺🇸Raleigh, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Cancer Treatment Center
🇺🇸Wooster, Ohio, United States
Precision Radiotherapy at University Pointe
🇺🇸West Chester, Ohio, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
MNAP Oncologic Center
🇺🇸Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Mount Nittany Medical Center
🇺🇸State College, Pennsylvania, United States
CCOP - Main Line Health
🇺🇸Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Naval Medical Center - Portsmouth
🇺🇸Portsmouth, Virginia, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Community Memorial Hospital Cancer Care Center
🇺🇸Menomonee Falls, Wisconsin, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
🇺🇸Racine, Wisconsin, United States
Tom Baker Cancer Centre - Calgary
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta
🇨🇦Edmonton, Alberta, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Margaret and Charles Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Doctor H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
London Regional Cancer Program at London Health Sciences Centre
🇨🇦London, Ontario, Canada
Northeastern Ontario Regional Cancer Centre
🇨🇦Sudbury, Ontario, Canada
Cancer Care Program at Thunder Bay Regional Health Sciences
🇨🇦Thunder Bay, Ontario, Canada
Edmond Odette Cancer Centre at Sunnybrook
🇨🇦Toronto, Ontario, Canada
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
McGill Cancer Centre at McGill University
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
Shawnee Mission Medical Center
🇺🇸Shawnee Mission, Kansas, United States
Menorah Medical Center
🇺🇸Overland Park, Kansas, United States
Providence Medical Center
🇺🇸Kansas City, Kansas, United States
Johnson County Radiation Therapy
🇺🇸Overland Park, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Radiological Associates of Sacramento Medical Group, Incorporated
🇺🇸Sacramento, California, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Truman Medical Center - Hospital Hill
🇺🇸Kansas City, Missouri, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Kansas City Cancer Center at St. Joseph's Medical Mall
🇺🇸Kansas City, Missouri, United States
St. Joseph Medical Center
🇺🇸Kansas City, Missouri, United States
North Kansas City Hospital
🇺🇸Kansas City, Missouri, United States
Parvin Radiation Oncology
🇺🇸Kansas City, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
🇺🇸Kansas City, Missouri, United States