A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer
N/A
N/A
Male
Prostate Cancer
Trial Information
A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Clinical stage T1b-T2b
- Meets one of the following criteria:
- Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but < 20 ng/mL
- Gleason score 7 AND PSA < 15 ng/mL
- No regional lymph node involvement
- No distant metastases
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other invasive malignancy within the past 5 years except localized basal cell or
squamous cell skin cancer
- No other major medical or psychiatric illness that would preclude study participation
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior cytotoxic chemotherapy
- No concurrent cytotoxic chemotherapy
Endocrine therapy:
- At least 3 months since prior finasteride
- No other prior hormonal therapy, including:
- Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
- Antiandrogens (e.g., flutamide or bicalutamide)
- Estrogens (e.g., diethylstilbestrol)
- No concurrent (neoadjuvant or adjuvant) hormonal therapy
Radiotherapy:
- No prior pelvic irradiation or prostatic brachytherapy
Surgery:
- No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
- No prior surgical castration (bilateral orchiectomy)
Other:
- At least 3 months since prior finasteride or PC SPES
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Jeff M. Michalski, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Washington University Siteman Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000069306
NCT ID:
NCT00033631
Start Date:
March 2002
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IIB prostate cancer
- stage IIA prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
| New York Methodist Hospital | Brooklyn, New York 11215-3609 |
| Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
| Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
| Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
| Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
| Breslin Cancer Center at Ingham Regional Medical Center | Lansing, Michigan 48910 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| Naval Medical Center - Portsmouth | Portsmouth, Virginia 23708-2197 |
| Mount Nittany Medical Center | State College, Pennsylvania 16803 |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine, Wisconsin 53405 |
| CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
| Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
| Danville Regional Medical Center | Danville, Virginia 24541 |
| Cancer Center at Ball Memorial Hospital | Muncie, Indiana 47303 |
| Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
| Menorah Medical Center | Overland Park, Kansas 66209 |
| Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
| Foote Memorial Hospital | Jackson, Michigan 49201 |
| Truman Medical Center - Hospital Hill | Kansas City, Missouri 64108 |
| St. Joseph Medical Center | Kansas City, Missouri 64114 |
| North Kansas City Hospital | Kansas City, Missouri 64116 |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
| Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
| Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
| Rex Cancer Center at Rex Hospital | Raleigh, North Carolina 27607 |
| Community Memorial Hospital Cancer Care Center | Menomonee Falls, Wisconsin 53051 |
| Providence Medical Center | Kansas City, Kansas 66112 |
| Johnson County Radiation Therapy | Overland Park, Kansas 66210 |
| Independence Regional Health Center | Independence, Missouri 64050 |
| Kansas City Cancer Center at St. Joseph's Medical Mall | Kansas City, Missouri 64114 |
| Parvin Radiation Oncology | Kansas City, Missouri 64116 |
| Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center | Kansas City, Missouri 64154 |
| Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
| CCOP - Main Line Health | Wynnewood, Pennsylvania 19096 |
| Bay Medical | Panama City, Florida 32401 |
| Oncology Center at Saint Margaret Mercy Healthcare Center | Hammond, Indiana 46320 |
| Central Maryland Oncology Center | Columbia, Maryland 21044 |
| Saint Mary's Regional Medical Center | Reno, Nevada 89503 |
| Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden, New Jersey 08103 |
| Lovelace Medical Center - Downtown | Albuquerque, New Mexico 87102 |
| Cancer Centers of North Carolina - Raleigh | Raleigh, North Carolina 27607 |
| Precision Radiotherapy at University Pointe | West Chester, Ohio 45069 |
| MNAP Oncologic Center | Philadelphia, Pennsylvania 19115 |
