Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI RTOG-0415 RTOG-0415, NCT00331773

Special Category: NCI Web site featured trial, CTSU trial

Objectives

Primary

1. 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

1. Compare time to local progression, freedom from biochemical recurrence, and disease-specific and overall survival of patients treated with these regimens.
2. Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens.
3. 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.
4. 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 .
5. 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.
6. 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.

Entry Criteria

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
  • No PSA measurement for ≥ 10 days after prostate biopsy
  • No PSA measurement for ≥ 30 days after discontinuation of finasteride (90 days after discontinuation of dutasteride)



• No regional lymph node involvement



• No distant metastases

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

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

Expected Enrollment

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

Outcomes

Disease-free survival at 5 years as measured by Kaplan-Meier

Time to failure
Disease-specific survival
Freedom from biochemical recurrence (FFBR)
Overall survival
Incidence of GU and GI acute and late toxicity
Statistical modeling of genomic biomarkers
Comparison of disease-specific HRQOL change in EPIC; the Utilization of Sexual Medications/Devices supplements the EPIC
Assessment of anxiety and depression change using the HSCL-25
Evaluation and comparison of the cost-utility of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis
Collection of paraffin-embedded tissue block, serum, plasma, and buffy coat cells for future translational research analyses

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.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

W. Robert Lee, MD, Protocol chair		Ph: 919-668-7342

U.S.A.
Alabama
	Mobile
	Mobile Infirmary Medical Center
		Clinical Trials Office - Mobile Infirmary Medical Center	Ph:  251-435-3942
Arizona
	Phoenix
	Arizona Oncology Services Foundation
		David Brachman, MD, FACRO	Ph:  602-274-4484
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Tucson
	Arizona Oncology - Tucson
		Vivek Kavadi	Ph:  520-797-4468
California
	Auburn
	Auburn Radiation Oncology
		Seth Rosenthal	Ph:  916-888-1266
	Berkeley
	Alta Bates Summit Comprehensive Cancer Center
		Clinical Trials Office - Alta Bates Summit Comprehensive Cancer Center	Ph:  510-204-3428
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Burlingame
	Peninsula Medical Center
		David Irwin, MD	Ph:  510-204-1591
	Cameron Park
	Radiation Oncology Centers - Cameron Park
		Seth Rosenthal	Ph:  916-622-9700
	Carmichael
	Mercy Cancer Center at Mercy San Juan Medical Center
		Seth Rosenthal	Ph:  916-904-3440
	Castro Valley
	East Bay Radiation Oncology Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Castro Valley
		James Feusner, MD	Ph:  510-428-3689
	Fremont
	Valley Medical Oncology
		James Feusner, MD	Ph:  510-428-3689
	Washington Township Hospital
		Byron Wilson, MD	Ph:  510-888-0657
	Greenbrae
	Marin Cancer Institute at Marin General Hospital
		David Irwin, MD	Ph:  510-204-1591
	Sutter Health - Western Division Cancer Research Group
		David Irwin, MD	Ph:  510-204-1591
	Hayward
	Kaiser Permanente Medical Center - Hayward
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Long Beach
	Veterans Affairs Medical Center - Long Beach
		Samar Azawi, MD	Ph:  562-826-5606
	Los Angeles
	Kaiser Permanente Medical Center - Los Angeles
		Michael Girvigian	Ph:  323-667-4011 800-954-8000
	Oakland
	Alta Bates Summit Medical Center - Summit Campus
		Clinical Trials Office - Alta Bates Summit Medical Center - Summit Campus	Ph:  510-204-1414
	Bay Area Breast Surgeons, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	CCOP - Bay Area Tumor Institute
		James Feusner, MD	Ph:  510-428-3689
	Kaiser Permanente Medical Center - Oakland
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Larry G Strieff MD Medical Corporation
		James Feusner, MD	Ph:  510-428-3689
	Tom K Lee, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	Pleasanton
	Valley Medical Oncology Consultants - Pleasanton
		James Feusner, MD	Ph:  510-428-3689
	Redwood City
	Kaiser Permanente Medical Center - Redwood City
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Richmond
	Kaiser Permanente Medical Center - Richmond
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Roseville
	Kaiser Permanente Medical Center - Roseville
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Radiation Oncology Center - Roseville
		Seth Rosenthal	Ph:  916-969-4422
	Sacramento
	Kaiser Permanente Medical Center - Sacramento
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Mercy General Hospital
		Seth Rosenthal	Ph:  916-453-4453
	Radiological Associates of Sacramento Medical Group, Incorporated
		Seth Rosenthal	Ph:  916-646-8300
	San Francisco
	California Pacific Medical Center - California Campus
		David Irwin, MD	Ph:  510-204-1591
	Kaiser Permanente Medical Center - San Francisco Geary Campus
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
	San Jose
	Kaiser Permanente Medical Center - Santa Teresa
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	San Pablo
	Doctors Medical Center - San Pablo Campus
		James Feusner, MD	Ph:  510-428-3689
	San Rafael
	Kaiser Foundation Hospital - San Rafael
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Santa Clara
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Kaiser Permanente Medical Center - Santa Clara Kiely Campus
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Santa Rosa
	Kaiser Permanente Medical Center - Santa Rosa
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	South San Francisco
	Kaiser Permanente Medical Center - South San Francisco
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Torrance
	Torrance Memorial Medical Center
		Thyra Endicott, MD	Ph:  310-517-4750
	Travis AFB
	General Robert Huyser Cancer Center at David Grant Medical Center
		Roland Engel, MD	Ph:  707-423-7691
	Vacaville
	Solano Radiation Oncology Center
		Seth Rosenthal	Ph:  707-447-0400
	Vallejo
	Sutter Solano Medical Center
		David Irwin, MD	Ph:  510-204-1591
	Walnut Creek
	Kaiser Permanente Medical Center - Walnut Creek
		Louis Fehrenbacher, MD	Ph:  707-651-2577
Colorado
	Aurora
	Aurora Presbyterian Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Rocky Mountain Cancer Centers - Aurora
		Vivek Kavadi	Ph:  303-418-7600
	University of Colorado Cancer Center at UC Health Sciences Center
		Clinical Trials Office - University of Colorado Cancer Center	Ph:  720-848-0650
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph:  719-776-5275
	Denver
	Porter Adventist Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Presbyterian - St. Luke's Medical Center
		Clinical Trials Office - Presbyterian - St. Luke's Medical Center	Ph:  303-839-6000
	St. Joseph Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Veterans Affairs Medical Center - Denver
		Rachel Rabinovitch, MD	Ph:  720-848-0116
	Englewood
	Swedish Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Fort Collins
	Poudre Valley Radiation Oncology
		C. Kelley Simpson, MD	Ph:  970-482-3328
	Grand Junction
	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Greeley
	North Colorado Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Lone Tree
	Sky Ridge Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Longmont
	Hope Cancer Care Center at Longmont United Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Loveland
	McKee Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Thornton
	North Suburban Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Wheat Ridge
	Exempla Lutheran Medical Center
		Clinical Trials Office - Exempla Lutheran Medical Center	Ph:  303-403-3605
Delaware
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
Florida
	Gainesville
	University of Florida Shands Cancer Center
		Clinical Trials Office - University of Florida Shands Cancer Center	Ph:  888-254-7581
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Miami
	Baptist-South Miami Regional Cancer Program
		Andre Abitbol, MD	Ph:  786-596-6566
	Panama City
	Bay Medical
		Hasan Murshed	Ph:  850-747-6972
Georgia
	Altanta
	Winship Cancer Institute of Emory University
		Ashesh Jani	Ph:  773-702-2526
	Atlanta
	Emory Crawford Long Hospital
		Ashesh Jani	Ph:  773-702-2526
	Georgia Cancer Center for Excellence at Grady Memorial Hospital
		Ashesh Jani	Ph:  773-702-2526
	Decatur
	Veterans Affairs Medical Center - Atlanta (Decatur)
		Scott Edelman	Ph:  404-728-7680
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Bloomington
	St. Joseph Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
	Galesburg
	InterCommunity Cancer Center of Western Illinois
		John Kugler, MD	Ph:  309-243-3605
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3605
	Olympia Fields
	Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
		Clinical Trials Office - Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields	Ph:  708-679-2217
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3605
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3605
		John Kugler, MD	Ph:  309-243-3605
	OSF St. Francis Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Spring Valley
	Valley Cancer Center
		John Kugler, MD	Ph:  309-243-3605
Indiana
	Indianapolis
	Central Indiana Cancer Centers - East
		Vivek Kavadi