Radiation Therapy in Treating Patients With Stage II Prostate Cancer



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:4/17/2018
Start Date:April 2006

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A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to
help focus thin beams of radiation directly on the tumor, and giving hypofractionated
radiation therapy (higher doses over a shorter period of time), may be less costly with fewer
side effects and just as effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying several different radiation therapy
regimens to compare how well they work in treating patients with stage II prostate cancer.

OBJECTIVES:

Primary

- Compare the disease-free survival (DFS) of patients with favorable-risk stage II
prostate cancer treated with hypofractionated vs conventionally fractionated
three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy
(IMRT).

Secondary

- Compare time to local progression, freedom from biochemical recurrence, and
disease-specific and overall survival of patients treated with these regimens.

- Determine the incidence of gastrointestinal and genitourinary toxic effects in patients
treated with these regimens.

- Compare the degree, duration, and significant differences in disease-specific
health-related quality of life (HRQOL) decrements, using the Expanded Prostate Cancer
Index Composite (EPIC), in patients treated with these regimens.

- Determine whether anxiety and/or depression, as measured by the Hopkins Symptom
Checklist-25 (HSCL-25), are decreased with therapy that improves DFS of these patients .

- Determine whether the incremental gain in DFS outweighs decrements in the generic
domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and
anxiety/depression) in patients treated with these regimens.

- Conduct a cost-utility analysis of hypofractionated 3D-CRT or IMRT as a prostate cancer
therapy if this regimen is shown to be as effective as conventionally fractionated
3D-CRT or IMRT in improving DFS.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
according to Gleason score (2-4 vs 5-6), prostate-specific antigen (PSA) level (< 4 ng/mL vs
4-<9 ng/mL), and planned radiotherapy 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 conventionally fractionated 3D-CRT or IMRT once daily 5 days a
week for 8.2 weeks (total of 41 treatments).

- Arm II: Patients undergo hypofractionated 3D-CRT or IMRT once daily 5 days a week for
5.6 weeks (total of 28 treatments).

Quality of life, anxiety, and depression are assessed at baseline and then at 6 months and 1,
2, and 5 years after the start of radiotherapy.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,067 patients will be accrued to this study.

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate within the past 6 months

- Clinical stage T1-2c

- Combined Gleason score 2-6

- Prostate-specific antigen (PSA) < 10 ng/mL within the past 6 months

- PSA evaluated at least 10 days after prostate biopsy

- For patients who received finasteride, PSA evaluated at least 30 after completion
of finasteride

- For patients who received dutasteride, PSA evaluated at least 90 after completion
of dutasteride

- No regional lymph node involvement

- No distant metastases

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- No unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- No transmural myocardial infarction within the past 6 months

- No acute bacterial or fungal infection requiring IV antibiotics

- No chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study treatment

- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- No known AIDS

- No prior or concurrent lymphomatous/hematogenous malignancy or other invasive
malignancy except nonmelanomatous skin cancer or any other cancer for which the
patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of
the bladder or oral cavity)

- No other severe, active comorbidity

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior radical prostatectomy or cryosurgery for prostate cancer

- No prior hormonal therapy, including any of the following:

- Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)

- Antiandrogens (e.g., flutamide or bicalutamide)

- Estrogens [e.g., diethylstilbestrol (DES)]

- Surgical castration (bilateral orchiectomy)

- No prior pelvic radiotherapy or prostate brachytherapy

- No prior or concurrent cytotoxic chemotherapy for prostate cancer

- At least 30 days since prior finasteride

- At least 90 days since prior dutasteride

- No concurrent neoadjuvant or adjuvant hormonal therapy

- Concurrent warfarin or other blood-thinning agents allowed
We found this trial at
283
sites
2635 North 7th Street
Grand Junction, Colorado 81501
970-298-CARE (2273)
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center St. Mary's Hospital...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481-2400
Rosenfeld Cancer Center at Abington Memorial Hospital As one of the most trusted cancer centers...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Bremerton, Washington 98310
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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100 North Academy Ave
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
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1719 East 19th Avenue
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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125 Science Dr
Durham, North Carolina 27710
888.275.3853
Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
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1376 Mowry Road
Gainesville, Florida 32610
(352) 273-8010
University of Florida Shands Cancer Center We are the University of Florida Health Cancer Center
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200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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300 Community Drive
Manhasset, New York 11030
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800 NE 10th Street
Oklahoma City, Oklahoma 73104
(855) 750-2273
Oklahoma University Cancer Institute The Peggy and Charles Stephenson Cancer Center is located on the...
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Panama City, Florida 32401
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620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
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2279 45th Street
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
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1717 S J St
Tacoma, Washington 98405
(253) 426-4101
Franciscan Cancer Center at St. Joseph Medical Center St. Joseph Medical Center is a 361-bed...
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
McDowell Cancer Center at Akron General Medical Center Learning that you or someone you love...
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161 North Forge Street
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
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Alexandria, Virginia 22304
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Ames, Iowa 50010
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
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Appleton, Wisconsin 54911
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Atlanta, Georgia 30308
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Auburn, California 95603
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700 Potomac St
Aurora, Colorado 80012
(303) 363-7200
Aurora Presbyterian Hospital At The Medical Center of Aurora and Centennial Medical Plaza, we treat...
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Barberton, Ohio 44203
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1233 34th St NW
Bemidji, Minnesota 56601
(218) 333-5000
MeritCare Bemidji Sanford Health is an integrated health system headquartered in the Dakotas and is...
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2450 Ashby Ave.
Berkeley, California 94705
(510) 204-4444
Alta Bates Summit Comprehensive Cancer Center Our Comprehensive Cancer Services are comprised of exceptional, state-of-the-art...
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Billings, Montana 59101
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Billings, Montana 59107
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Binghamton, New York 13905
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500 N 8th St
Bismarck, North Dakota 58501
(701) 222-6100
Bismarck Cancer Center The Bismarck Cancer Center (BCC) is a joint venture between Sanford Health...
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720 E Rosser Ave
Bismarck, North Dakota 58501
(701) 323-6741
Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
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900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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900 East Broadway
Bismarck, North Dakota 58501
701.530.7000
St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
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2200 E Washington St,
Bloomington, Illinois 61701
(309) 662-3311
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72 East Concord St.
Boston, Massachusetts 02118
617-638-4173
Boston University Cancer Research Center
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44 Binney St
Boston, Massachusetts 02115
(617) 632-6364
Dana-Farber/Brigham and Women's Cancer Center Boston's Brigham and Women's Hospital (BWH) is an international leader...
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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931 Highland Blvd
Bozeman, Montana 59715
(406) 585-5070
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
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Burlingame, California 94010
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
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Cameron Park, California 95682
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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20126 Stanton Ave
Castro Valley, California 94546
(510) 581-0556
East Bay Radiation Oncology Center East Bay Radiation Oncology Center offers superior medical and technical...
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20055 Lake Chabot Rd #130
Castro Valley, California 94546
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1303 North Main Street
Cedar City, Utah 84721
(435) 868-5680
Sandra L. Maxwell Cancer Center The Huntsman-Intermountain Cancer Center at Valley View Medical Center in...
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3110 MacCorkle Ave. S.E.
Charleston, West Virginia 25304
304-347-1206
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Cincinnati, Ohio 45267
513-584-7698
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18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
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2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
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Columbia, Maryland 21044
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Concord, New Hampshire 03301
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11850 Blackfoot St. NW Suite 130
Coon Rapids, Minnesota 55433
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142 S Main St
Danville, Virginia 24541
(434) 799-2100
Danville Regional Medical Center For more than 120 years, Danville Regional Medical Center has been...
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Darby, Pennsylvania 19023
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2300 N. Edward Street
Decatur, Illinois 62526
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Denver, Colorado 80218
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2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
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2799 W Grand Blvd
Detroit, Michigan 48202
(888) 777-4167
Josephine Ford Cancer Center at Henry Ford Hospital A diagnosis of cancer is one of...
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Duluth, Minnesota 55805
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Duluth, Minnesota 55805
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400 E Third Street
Duluth, Minnesota 55805
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502 E 2nd St,
Duluth, Minnesota 55805
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5008 Brittonfield Parkway
East Syracuse, New York 13057
(315) 472-7504
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6401 France Ave S
Edina, Minnesota 55435
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501 E. Hampden Ave.
Englewood, Colorado 80113
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