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A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer


Phase 3
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

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 InstituteBuffalo, New York  14263
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
CCOP - Kansas CityKansas City, Missouri  64131
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
New York Methodist HospitalBrooklyn, New York  11215-3609
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
LDS HospitalSalt Lake City, Utah  84143
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Naval Medical Center - PortsmouthPortsmouth, Virginia  23708-2197
Mount Nittany Medical CenterState College, Pennsylvania  16803
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
All Saints Cancer Center at Wheaton Franciscan HealthcareRacine, Wisconsin  53405
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Danville Regional Medical CenterDanville, Virginia  24541
Cancer Center at Ball Memorial HospitalMuncie, Indiana  47303
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Cancer Treatment CenterWooster, Ohio  44691
Lawrence Memorial HospitalLawrence, Kansas  66044
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
Foote Memorial HospitalJackson, Michigan  49201
Truman Medical Center - Hospital HillKansas City, Missouri  64108
St. Joseph Medical CenterKansas City, Missouri  64114
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Rex Cancer Center at Rex HospitalRaleigh, North Carolina  27607
Community Memorial Hospital Cancer Care CenterMenomonee Falls, Wisconsin  53051
Providence Medical CenterKansas City, Kansas  66112
Johnson County Radiation TherapyOverland Park, Kansas  66210
Independence Regional Health CenterIndependence, Missouri  64050
Kansas City Cancer Center at St. Joseph's Medical MallKansas City, Missouri  64114
Parvin Radiation OncologyKansas City, Missouri  64116
Radiation Oncology Associates of Kansas City at Northland Radiation Oncology CenterKansas City, Missouri  64154
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
Bay MedicalPanama City, Florida  32401
Oncology Center at Saint Margaret Mercy Healthcare CenterHammond, Indiana  46320
Central Maryland Oncology CenterColumbia, Maryland  21044
Saint Mary's Regional Medical CenterReno, Nevada  89503
Cancer Institute of New Jersey at Cooper University Hospital - CamdenCamden, New Jersey  08103
Lovelace Medical Center - DowntownAlbuquerque, New Mexico  87102
Cancer Centers of North Carolina - RaleighRaleigh, North Carolina  27607
Precision Radiotherapy at University PointeWest Chester, Ohio  45069
MNAP Oncologic CenterPhiladelphia, Pennsylvania  19115