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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 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