Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer

A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY FOR ADENOCARCINOMA OF THE PROSTATE

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have previously untreated stage II or stage III prostate cancer.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: 3D-CRT

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy to the prostate gland and immediately surrounding tissues in patients with stage II or III adenocarcinoma of the prostate. II. Determine the normal tissue toxicity rate of this regimen in the rectums and bladders of these patients. III. Determine local control by clinical and pathologic examination and by PSA determinations in patients treated with this regimen. IV. Determine the distant failure and overall survival of patients treated with this regimen.

OUTLINE: This is a dose escalation study. Patients are stratified according to 1 of the following 3 prognostic groups: Group 1: T1b-c or T2a-b with combined PSA/Gleason (CPG) score 15 and under Group 2: T1b-c or T2a-b with CPG score more than 15, or any T2c with PSA less than 70 ng/mL Group 3: T3 with prostate specific antigen (PSA) less than 70 ng/mL Patients receive 3-dimensional (3-D) conformal radiotherapy 5 days a week for 7.6, 8.2, or 8.8 weeks. Cohorts of 120-270 patients receive escalating doses of 3-D conformal radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 20% of patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 549-801 patients (120-204 patients for the first dose level, 237-321 patients for the second dose level, and 192-276 patients for the third dose level) will be accrued for this study within 4.75 to 5.25 years.

• Study Type: Interventional
• Enrollment (Actual): 1084
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center - Calgary
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Doctor Leon Richard Oncology Centre
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Cancer Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Cancer Care Ontario-Hamilton Regional Cancer Centre
    • Kingston, Ontario, Canada, K7L 5P9
      • Kingston Regional Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • Cancer Care Ontario-London Regional Cancer Centre
    • Ottawa, Ontario, Canada, K1Y 4K7
      • Ottawa Regional Cancer Centre - Civic Campus
    • Sudbury, Ontario, Canada, P3E 5J1
      • Northeastern Ontario Regional Cancer Centre, Sudbury
    • Thunder Bay, Ontario, Canada, P7A 7T1
      • Northwestern Ontario Regional Cancer Centre, Thunder Bay
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto Sunnybrook Regional Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2W 1S6
      • McGill University Department of Oncology
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Comprehensive Cancer Center
    • Huntsville, Alabama, United States, 35801
      • Comprehensive Cancer Institute of Huntsville
    • Mobile, Alabama, United States, 36688
      • MBCCOP - University of South Alabama
    • Mobile, Alabama, United States, 36640-0460
      • Mobile Infirmary Medical Center
    • Montgomery, Alabama, United States, 36106-2801
      • Alabama Oncology, LLC
    • Tuscaloosa, Alabama, United States, 35401
      • Radiation Oncology Associates of West Alabama
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Providence Cancer Therapy Center
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Arizona Cancer Center
  • California
    • Concord, California, United States, 94524-4110
      • Mount Diablo Medical Center
    • Fresno, California, United States, 93720
      • California Cancer Center
    • Fresno, California, United States, 93720
      • Saint Agnes Cancer Center
    • Glendale, California, United States, 91204
      • Glendale Memorial Hospital and Health Center
    • Greenbrae, California, United States, 94904
      • Sutter Health Western Division Cancer Research Group
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Long Beach, California, United States, 90822
      • Veterans Affairs Medical Center - Long Beach
    • Los Angeles, California, United States, 90033-0800
      • USC/Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center, UCLA
    • Los Angeles, California, United States, 91010
      • Beckman Research Institute, City of Hope
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Medical Center - Los Angeles
    • Oakland, California, United States, 94609-3305
      • CCOP - Bay Area Tumor Institute
    • Pomona, California, United States, 91767
      • Cancer Care Center
    • Sacramento, California, United States, 95816
      • Radiation Oncology Center - Sacramento
    • San Francisco, California, United States, 94115-0128
      • UCSF Cancer Center and Cancer Research Institute
    • San Jose, California, United States, 95128
      • O'Connor Hospital
    • Santa Rosa, California, United States, 95403
      • CCOP - Santa Rosa Memorial Hospital
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Memorial Hospital Cancer Center
    • Denver, Colorado, United States, 80262
      • University of Colorado Cancer Center
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
    • Norwalk, Connecticut, United States, 06856
      • Whittingham Cancer Center
  • Delaware
    • Wilmington, Delaware, United States, 19899
      • CCOP - Christiana Care Health Services
  • District of Columbia
    • Washington, District of Columbia, United States, 20307-5000
      • Walter Reed Army Medical Center
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Halifax Medical Center
    • Fort Myers, Florida, United States, 33901
      • Radiation Therapy Associates - Fort Myers
    • Gainesville, Florida, United States, 32610-0296
      • University of Florida Health Science Center
    • Melbourne, Florida, United States, 32901
      • Health First Holmes Regional Medical Center
    • Miami, Florida, United States, 33136
      • Sylvester Cancer Center, University of Miami
    • Miami, Florida, United States, 33176-2197
      • Baptist Hospital of Miami
    • Miami Beach, Florida, United States, 33140
      • CCOP - Mount Sinai Medical Center
    • Orange Park, Florida, United States, 32073
      • Florida Radiation Oncology Group
    • Orlando, Florida, United States, 32806
      • MD Anderson Cancer Center Orlando
    • Panama City, Florida, United States, 32405-4587
      • Gulf Coast Cancer Treatment Center
    • Pensacola, Florida, United States, 32514
      • West Florida Cancer Institute - Pensacola
    • Saint Petersburg, Florida, United States, 33701
      • Bayfront Medical Center
    • Sarasota, Florida, United States, 34233
      • Sarasota Radiation and Medical Oncology Center
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital - Atlanta
    • Atlanta, Georgia, United States, 30342-1701
      • CCOP - Atlanta Regional
    • Columbus, Georgia, United States, 31902
      • Medical Center/John B. Amos Community Cancer Center
    • Rome, Georgia, United States, 30161
      • InterCommunity Cancer Center at Rome
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Community Hospital
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60637
      • University of Chicago Cancer Research Center
    • Decatur, Illinois, United States, 62526
      • CCOP - Central Illinois
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Park Ridge, Illinois, United States, 60068
      • Lutheran General Cancer Care Center
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
  • Indiana
    • Anderson, Indiana, United States, 46016
      • St. John's Medical Center
    • Indianapolis, Indiana, United States, 46206-1367
      • Clarion Health Partners Inc.
    • Indianapolis, Indiana, United States, 46219
      • Community Hospitals of Indianapolis - Regional Cancer Center
    • Muncie, Indiana, United States, 47303-3499
      • Ball Memorial Hospital
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
    • South Bend, Indiana, United States, 46617
      • St. Joseph's Radiation Oncology Center
  • Iowa
    • Dubuque, Iowa, United States, 52001
      • Wendt Regional Cancer Center of Finley Hospital
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Lexington, Kentucky, United States, 40511-1093
      • Veterans Affairs Medical Center - Lexington
    • Lexington, Kentucky, United States, 40536-0084
      • Albert B. Chandler Medical Center, University of Kentucky
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center
    • Louisville, Kentucky, United States, 40215
      • Louisville Radiation Oncology
    • Madisonville, Kentucky, United States, 42431
      • Merle M. Mahr Cancer Center
    • Paducah, Kentucky, United States, 42001
      • Western Baptist Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Cancer Center
    • Lafayette, Louisiana, United States, 70501
      • Romagosa Radiation Oncology Center
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
    • New Orleans, Louisiana, United States, 70112
      • MBCCOP - LSU Medical Center
    • New Orleans, Louisiana, United States, 70121
      • CCOP - Ochsner
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Oncology Center
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center and Cancer Center
    • Baltimore, Maryland, United States, 21225
      • Harbor Hospital Center
    • Baltimore, Maryland, United States, 21237
      • Radiation Oncology Affiliates of Maryland, P.A.
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Oncology Center
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Hospital
    • Jamaica Plain, Massachusetts, United States, 02130
      • Veterans Affairs Medical Center - Boston (Jamaica Plain)
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0752
      • University of Michigan Comprehensive Cancer Center
    • Ann Arbor, Michigan, United States, 48106
      • CCOP - Ann Arbor Regional
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
    • Flint, Michigan, United States, 48432
      • McLaren Regional Cancer Center
    • Kalamazoo, Michigan, United States, 49007-3731
      • CCOP - Kalamazoo
    • Marquette, Michigan, United States, 49855
      • Marquette General Hospital
    • Midland, Michigan, United States, 48670
      • MidMichigan Regional Medical Center
    • Saginaw, Michigan, United States, 48601
      • St. Mary's Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center - Columbia
    • Kansas City, Missouri, United States, 64131
      • CCOP - Kansas City
    • Saint Louis, Missouri, United States, 63110-0250
      • St. Louis University Health Sciences Center
    • Saint Louis, Missouri, United States, 63110
      • Mallinckrodt Institute of Radiology
    • Springfield, Missouri, United States, 65807
      • CCOP - Cancer Research for the Ozarks
    • Springfield, Missouri, United States, 65807
      • Cancer Research for the Ozarks
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Cancer Center - Omaha
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Southern Nevada Cancer Research Foundation
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Norris Cotton Cancer Center
    • Manchester, New Hampshire, United States, 03103
      • Elliot Regional Cancer Center
  • New Jersey
    • East Orange, New Jersey, United States, 07018-1095
      • Veterans Affairs Medical Center - East Orange
    • Edison, New Jersey, United States, 08818
      • John F. Kennedy Medical Center
    • Elizabeth, New Jersey, United States, 07201
      • Trinitas Hospital - Jersey Street Campus
    • Millville, New Jersey, United States, 08332
      • South Jersey Hospital - Millville
    • Mount Holly, New Jersey, United States, 08060
      • Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
    • Toms River, New Jersey, United States, 08755
      • Community Medical Center
    • Trenton, New Jersey, United States, 08629
      • St. Francis Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Saint Joseph Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Cancer Center of Albany Medical Center
    • Bronx, New York, United States, 10461
      • Albert Einstein Comprehensive Cancer Center
    • Brooklyn, New York, United States, 11203
      • State University of New York Health Science Center at Brooklyn
    • Brooklyn, New York, United States, 11215-3609
      • New York Methodist Hospital
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute
    • Clifton Springs, New York, United States, 14432
      • Finger Lakes Radiation Oncology, P.C.
    • Manhasset, New York, United States, 11030
      • CCOP - North Shore University Hospital
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
    • New York, New York, United States, 10016
      • Kaplan Cancer Center
    • Plattsburgh, New York, United States, 12901
      • Champlain Valley Physicians Hospital Medical Center
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester Cancer Center
    • Valhalla, New York, United States, 10595
      • New York Medical College
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center, UNC
    • Concord, North Carolina, United States, 28025
      • Northeast Medical Center
    • Greenville, North Carolina, United States, 27858-4354
      • East Carolina University School of Medicine
    • Hickory, North Carolina, United States, 28601
      • Catawba Memorial Hospital
    • Winston-Salem, North Carolina, United States, 27104-4241
      • CCOP - Southeast Cancer Control Consortium
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Meritcare Roger Maris Cancer Center
    • Minot, North Dakota, United States, 58701
      • UNIMED Medical Center
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron General Medical Center
    • Akron, Ohio, United States, 44309
      • Akron City Hospital
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Cancer Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Cleveland, Ohio, United States, 44106-5065
      • Ireland Cancer Center
    • Columbus, Ohio, United States, 43206
      • CCOP - Columbus
    • Columbus, Ohio, United States, 43210
      • Arthur G. James Cancer Hospital - Ohio State University
    • Kettering, Ohio, United States, 45429
      • CCOP - Dayton
    • Toledo, Ohio, United States, 43623-3456
      • CCOP - Toledo Community Hospital Oncology Program
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • St. John Medical Center
  • Oregon
    • Portland, Oregon, United States, 97213
      • CCOP - Columbia River Program
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • LeHigh Valley Hospital
    • Danville, Pennsylvania, United States, 17822-2001
      • Penn State Geisinger Medical Center
    • Darby, Pennsylvania, United States, 19023
      • Mercy Catholic Medical Center, Mercy Fitzgerald Divison
    • Drexel Hill, Pennsylvania, United States, 19026
      • Delaware County Memorial Hospital
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Geisinger Cancer Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Veterans Affairs Medical Center - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19107
      • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Cancer Center
    • Philadelphia, Pennsylvania, United States, 19102-1192
      • Hahnemann University Hospital
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Cancer Institute
    • Pittsburgh, Pennsylvania, United States, 15219
      • Mercy Hospital of Pittsburgh
    • Reading, Pennsylvania, United States, 19612-6052
      • Reading Hospital and Medical Center
    • Scranton, Pennsylvania, United States, 18501
      • Mercy Hospital Cancer Center - Scranton
    • Wilkes-Barre, Pennsylvania, United States, 18764
      • Wilkes Barre General Hospital
    • Wynnewood, Pennsylvania, United States, 19096
      • CCOP - MainLine Health
    • York, Pennsylvania, United States, 17315
      • York Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02908-4735
      • Roger Williams Medical Center/BUSM
  • South Carolina
    • Charleston, South Carolina, United States, 29425-0721
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29615
      • CCOP - Greenville
    • Spartanburg, South Carolina, United States, 29303
      • CCOP - Upstate Carolina
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Jackson-Madison County General Hospital
    • Knoxville, Tennessee, United States, 37901
      • Baptist Regional Cancer Center - Knoxville
    • Memphis, Tennessee, United States, 38117
      • CCOP - Baptist Cancer Institute
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee, Memphis Cancer Center
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt Cancer Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Harrington Cancer Center
    • Beaumont, Texas, United States, 77701
      • Julie and Ben Rogers Cancer Institute
    • Galveston, Texas, United States, 77555-1329
      • University of Texas Medical Branch
    • Lackland Air Force Base, Texas, United States, 78236-5300
      • Wilford Hall - 59th Medical Wing
    • Lubbock, Texas, United States, 79410-1894
      • Joe Arrington Cancer Research and Treatment Center
    • Pasadena, Texas, United States, 77504
      • Bayshore Medical Center
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center - Cancer Institute
  • Utah
    • Saint George, Utah, United States, 84770
      • Dixie Regional Medical Center
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital
  • Vermont
    • Bennington, Vermont, United States, 05201
      • CCOP - Southwestern Vermont Regional Cancer Center
    • Burlington, Vermont, United States, 05401-3498
      • Vermont Cancer Center
    • Rutland, Vermont, United States, 05701
      • Green Mountain Oncology Group
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Martha Jefferson Hospital
    • Charlottesville, Virginia, United States, 22908
      • Cancer Center, University of Virginia HSC
    • Lynchburg, Virginia, United States, 24503
      • Virginia Baptist Hospital
    • Portsmouth, Virginia, United States, 23708-2197
      • Naval Medical Center, Portsmouth
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98111
      • Virginia Mason Medical Center
    • Spokane, Washington, United States, 99210-0248
      • Deaconess Medical Center
    • Yakima, Washington, United States, 98902
      • Yakima Valley Memorial Hospital
  • West Virginia
    • Wheeling, West Virginia, United States, 26003
      • Schiffler Cancer Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54307-3508
      • St. Vincent Hospital
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Foundation
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Comprehensive Cancer Center
    • Madison, Wisconsin, United States, 53713
      • Southern Wisconsin Radiotherapy Center
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic
    • Menomonee Falls, Wisconsin, United States, 53051
      • Community Memorial Hospital
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53210
      • St. Joseph's Hospital
    • Milwaukee, Wisconsin, United States, 53211
      • Columbia Hospital
    • Milwaukee, Wisconsin, United States, 53215
      • St. Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53295
      • Veterans Affairs Medical Center - Milwaukee (Zablocki)
    • Racine, Wisconsin, United States, 53405
      • Southeastern Wisconsin Regional Cancer Center
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

DISEASE CHARACTERISTICS: Previously untreated adenocarcinoma of the prostate T1b-c or T2a-b with a Gleason score more than 5 and PSA greater than 4 ng/mL OR Any T3 PSA under 70 ng/mL within 3 weeks prior to entry and at least 10 days after prostate biopsy No biopsy proven regional nodal involvement No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Hematopoietic: White blood cell (WBC) count of at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11 g/dL Hepatic: Not specified Renal: Not specified Other: No major medical or psychiatric illness that would preclude study No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No prior pelvic irradiation Surgery: No prior prostatectomy or cryosurgery for prostate cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Clinical stages T1b-c or T2a-b with PSA + ([Gleason -6] x 10) is ≤ 15. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.	Radiation: 3D-CRT; 3 dimensional conformal radiation therapy; Other Names: 3 dimensional conformal radiation therapy
Experimental: Group 2; Clinical stages T1b-c or T2a-b with PSA + ([Gleason -6]x10)>15. Any clinical T2c with PSA < 70. Must be lymph node negative. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.	Radiation: 3D-CRT; 3 dimensional conformal radiation therapy; Other Names: 3 dimensional conformal radiation therapy
Experimental: Group 3; Clinical stage T3 with PSA < 70. Must be lymph node negative. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.	Radiation: 3D-CRT; 3 dimensional conformal radiation therapy; Other Names: 3 dimensional conformal radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To establish the maximum tolerated dose (MTD) of radiation that can be delivered to the prostate gland and immediate surrounding tissues in patients with carcinoma of the prostate using three dimensional conformal radiation therapy (3D-CRT).	From registration to approximately 18 months from the start of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
To quantify the normal tissue toxicity rate (normal tissue complication probability (NTCP)) for rectum and bladder using 3D-CRT	From registration to approximately 18 months from the start of treatment
To evaluate local control by clinical, pathologic, and PSA (stable in normal range) determinations	From registration to the date of progression or last follow-up. Analysis will occur after the primary endpoint analysis.
Distant metastasis and survival	From registration to the date of death or last follow-up. Analysis will occur after the primary endpoint analysis.

Collaborators and Investigators

• Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI); NRG Oncology
• Investigators: Study Chair: James D. Cox, MD, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• Du KL, Bae K, Movsas B, Yan Y, Bryan C, Bruner DW. Impact of marital status and race on outcomes of patients enrolled in Radiation Therapy Oncology Group prostate cancer trials. Support Care Cancer. 2012 Jun;20(6):1317-25. doi: 10.1007/s00520-011-1219-4. Epub 2011 Jul 1.
• Roach M, Moughan J, Movsas B, et al.: Socio-demographic predictors of biochemical failure and survival among high risk patients treated on Radiation Therapy Oncology Group (RTOG) prostate cancer trials: a meta-analysis. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1127, S204, 2006.
• Michalski J, Winter K, Roach M, Markoe A, Sandler HM, Ryu J, Parliament M, Purdy JA, Valicenti RK, Cox JD. Clinical outcome of patients treated with 3D conformal radiation therapy (3D-CRT) for prostate cancer on RTOG 9406. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):e363-70. doi: 10.1016/j.ijrobp.2011.12.070.
• Tucker SL, Dong L, Michalski JM, Bosch WR, Winter K, Cox JD, Purdy JA, Mohan R. Do intermediate radiation doses contribute to late rectal toxicity? An analysis of data from radiation therapy oncology group protocol 94-06. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):390-5. doi: 10.1016/j.ijrobp.2011.11.073. Epub 2012 Feb 17.
• Tucker SL, Michalski JM, Bosch WR, Mohan R, Dong L, Winter K, Purdy JA, Cox JD. Use of fractional dose-volume histograms to model risk of acute rectal toxicity among patients treated on RTOG 94-06. Radiother Oncol. 2012 Jul;104(1):109-13. doi: 10.1016/j.radonc.2012.04.023. Epub 2012 Jun 5.
• Tucker SL, Thames HD, Michalski JM, Bosch WR, Mohan R, Winter K, Cox JD, Purdy JA, Dong L. Estimation of alpha/beta for late rectal toxicity based on RTOG 94-06. Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):600-5. doi: 10.1016/j.ijrobp.2010.11.080. Epub 2011 Mar 4.
• Valicenti RK, Bae K, Michalski J, Sandler H, Shipley W, Lin A, Cox J. Does hormone therapy reduce disease recurrence in prostate cancer patients receiving dose-escalated radiation therapy? An analysis of Radiation Therapy Oncology Group 94-06. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1323-9. doi: 10.1016/j.ijrobp.2010.01.009.
• Michalski JM, Bae K, Roach M, Markoe AM, Sandler HM, Ryu J, Parliament MB, Straube W, Valicenti RK, Cox JD. Long-term toxicity following 3D conformal radiation therapy for prostate cancer from the RTOG 9406 phase I/II dose escalation study. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):14-22. doi: 10.1016/j.ijrobp.2009.01.062.
• Tucker SL, Dong L, Bosch WR, Michalski J, Winter K, Mohan R, Purdy JA, Kuban D, Lee AK, Cheung MR, Thames HD, Cox JD. Late rectal toxicity on RTOG 94-06: analysis using a mixture Lyman model. Int J Radiat Oncol Biol Phys. 2010 Nov 15;78(4):1253-60. doi: 10.1016/j.ijrobp.2010.01.069. Epub 2010 Jul 2.
• Cheung MR, Tucker SL, Dong L, et al.: Dose-volume analyses of grade ≥ 2 late rectal toxicity among patients treated on protocol RTOG 94-06. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-16, S9, 2007.
• Tucker SL, Dong L, Bosch WR, et al.: Fit of a generalized Lyman normal-tissue complication probability (NTCP) model to grade ≥ 2 late rectal toxicity data from patients treated on protocol RTOG 94-06. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-15, S8-9, 2007.
• Valicenti RK, Bae K, Michalski J, et al.: Does adjuvant hormonal therapy improve freedom from biochemical relapse in prostate cancer patients receiving dose- escalated radiation therapy? An analysis of RTOG 94-06. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-297, 2007.
• Michalski JM, Winter K, Purdy JA, Parliament M, Wong H, Perez CA, Roach M, Bosch W, Cox JD. Toxicity after three-dimensional radiotherapy for prostate cancer on RTOG 9406 dose Level V. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):706-13. doi: 10.1016/j.ijrobp.2004.11.028.
• Michalski JM, Winter K, Purdy JA, Perez CA, Ryu JK, Parliament MB, Valicenti RK, Roach M 3rd, Sandler HM, Markoe AM, Cox JD. Toxicity after three-dimensional radiotherapy for prostate cancer with RTOG 9406 dose level IV. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):735-42. doi: 10.1016/S0360-3016(03)01578-5.
• Roach M, Winter K, Michalski JM, Cox JD, Purdy JA, Bosch W, Lin X, Shipley WS. Penile bulb dose and impotence after three-dimensional conformal radiotherapy for prostate cancer on RTOG 9406: findings from a prospective, multi-institutional, phase I/II dose-escalation study. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1351-6. doi: 10.1016/j.ijrobp.2004.05.026.
• Michalski JM, Winter K, Purdy JA, Wilder RB, Perez CA, Roach M, Parliament MB, Pollack A, Markoe AM, Harms W, Sandler HM, Cox JD. Preliminary evaluation of low-grade toxicity with conformal radiation therapy for prostate cancer on RTOG 9406 dose levels I and II. Int J Radiat Oncol Biol Phys. 2003 May 1;56(1):192-8. doi: 10.1016/s0360-3016(03)00072-5.
• Michalski J, Winter K, Purdy JA, et al.: Toxicity following 3D radiation therapy for prostate cancer on RTOG 9406 dose level V. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S151, 2003.
• Valicenti RK, Winter K, Cox JD, Sandler HM, Bosch W, Vijayakumar S, Michalski J, Purdy J. RTOG 94-06: is the addition of neoadjuvant hormonal therapy to dose-escalated 3D conformal radiation therapy for prostate cancer associated with treatment toxicity? Int J Radiat Oncol Biol Phys. 2003 Nov 1;57(3):614-20. doi: 10.1016/s0360-3016(03)00640-0.
• Michalski JM, Purdy JA, Winter K, Roach M 3rd, Vijayakumar S, Sandler HM, Markoe AM, Ritter MA, Russell KJ, Sailer S, Harms WB, Perez CA, Wilder RB, Hanks GE, Cox JD. Preliminary report of toxicity following 3D radiation therapy for prostate cancer on 3DOG/RTOG 9406. Int J Radiat Oncol Biol Phys. 2000 Jan 15;46(2):391-402. doi: 10.1016/s0360-3016(99)00443-5.
• Roach M, Winter K, Michalski J, et al.: Mean dose of radiation to the bulb of penis correlates with risk of impotence at 24 months: preliminary analysis of Radiation Therapy Oncology Group (RTOG) phase I/II dose escalation trial 94-06. Int J Radiat Oncol Biol Phys 48(3 suppl): A-2104, 316, 2000.

Study record dates

Study Major Dates

• Study Start: May 1, 1994
• Primary Completion (Actual): March 1, 2004
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: May 25, 2004
• First Posted (Estimate): May 26, 2004

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: stage III prostate cancer; adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: RTOG-9406; CDR0000063854