Back to results

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Conventional 3D-CRT or IMRT

Hypofractionated 3D-CRT or IMRT

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arizona Oncology Services Foundation
Arizona Oncology - Tucson
Auburn Radiation Oncology
Alta Bates Summit Comprehensive Cancer Center
Providence Saint Joseph Medical Center - Burbank
Peninsula Medical Center
Radiation Oncology Centers - Cameron Park
Mercy Cancer Center at Mercy San Juan Medical Center
East Bay Radiation Oncology Center
Valley Medical Oncology Consultants - Castro Valley
Valley Medical Oncology
Marin Cancer Institute at Marin General Hospital
Sutter Health - Western Division Cancer Research Group
Kaiser Permanente Medical Center - Hayward
Veterans Affairs Medical Center - Long Beach
Kaiser Permanente Medical Center - Los Angeles
Alta Bates Summit Medical Center - Summit Campus
Bay Area Breast Surgeons, Incorporated
CCOP - Bay Area Tumor Institute
Larry G Strieff MD Medical Corporation
Tom K Lee, Incorporated
Kaiser Permanente - Division of Research - Oakland
Kaiser Permanente Medical Center - Oakland
Valley Medical Oncology Consultants - Pleasanton
Kaiser Permanente Medical Center - Rancho Cordova
Kaiser Permanente Medical Center - Redwood City
Kaiser Permanente Medical Center - Richmond
Rohnert Park Cancer Center
Kaiser Permanente Medical Center - Roseville
Radiation Oncology Center - Roseville
Radiological Associates of Sacramento Medical Group, Incorporated
University of California Davis Cancer Center
Mercy General Hospital
South Sacramento Cancer Center
South Sacramento Kaiser-Permanente Medical Center
Kaiser Permanente Medical Center - Sacramento
Kaiser Permanente Medical Center - San Francisco Geary Campus
UCSF Helen Diller Family Comprehensive Cancer Center
California Pacific Medical Center - California Campus
Kaiser Permanente Medical Center - Santa Teresa
Doctors Medical Center - San Pablo Campus
Kaiser Foundation Hospital - San Rafael
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Kaiser Permanente Medical Center - Santa Rosa
Kaiser Permanente Medical Center - South San Francisco
Kaiser Permanente Medical Facility - Stockton
General Robert Huyser Cancer Center at David Grant Medical Center
Solano Radiation Oncology Center
Sutter Solano Medical Center
Kaiser Permanente Medical Center - Walnut Creek
Aurora Presbyterian Hospital
Rocky Mountain Cancer Centers - Aurora
Boulder Community Hospital
Penrose Cancer Center at Penrose Hospital
Porter Adventist Hospital
Presbyterian - St. Luke's Medical Center
St. Joseph Hospital
Swedish Medical Center
Poudre Valley Radiation Oncology
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
North Colorado Medical Center
Sky Ridge Medical Center
Hope Cancer Care Center at Longmont United Hospital
McKee Medical Center
St. Mary - Corwin Regional Medical Center
North Suburban Medical Center
Exempla Lutheran Medical Center
CCOP - Christiana Care Health Services
University of Florida Shands Cancer Center
Mayo Clinic - Jacksonville
Baptist-South Miami Regional Cancer Program
Bay Medical
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Emory Crawford Long Hospital
Winship Cancer Institute of Emory University
Veterans Affairs Medical Center - Atlanta (Decatur)
Saint Anthony's Hospital at Saint Anthony's Health Center
St. Joseph Medical Center
University of Chicago Cancer Research Center
Decatur Memorial Hospital Cancer Care Institute
BroMenn Regional Medical Center
Community Cancer Center
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Cancer Treatment Center at Pekin Hospital
OSF St. Francis Medical Center
CCOP - Illinois Oncology Research Association
Oncology Hematology Associates of Central Illinois, PC - Peoria
Methodist Medical Center of Illinois
Methodist Cancer Center at Methodist Hospital
Central Indiana Cancer Centers - East
McFarland Clinic, PC
Holden Comprehensive Cancer Center at University of Iowa
Mercy Cancer Center at Mercy Medical Center - North Iowa
Siouxland Hematology-Oncology Associates, LLP
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Cancer Centers - Southwest
Norton Suburban Hospital
James Graham Brown Cancer Center at University of Louisville
Greenebaum Cancer Center at University of Maryland Medical Center
Central Maryland Oncology Center
Tate Cancer Center at Baltimore Washington Medical Center
Helen P. Denit Cancer Center at Montgomery General Hospital
Massachusetts General Hospital
Dana-Farber/Brigham and Women's Cancer Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston University Cancer Research Center
Beth Israel Deaconess Medical Center
Hudner Oncology Center at Saint Anne's Hospital - Fall River
MetroWest Medical Center - Framingham Union Hospital
Lowell General Hospital
Veterans Affairs Medical Center - Ann Arbor
University of Michigan Comprehensive Cancer Center
Barbara Ann Karmanos Cancer Institute
Josephine Ford Cancer Center at Henry Ford Hospital
Great Lakes Cancer Institute at McLaren Regional Medical Center
Foote Memorial Hospital
Albert Lea Cancer Center at Albert Lea Medical Center
MeritCare Bemidji
Fairview Ridges Hospital
Mercy and Unity Cancer Center at Mercy Hospital
Duluth Clinic Cancer Center - Duluth
CCOP - Duluth
Miller - Dwan Medical Center
St. Luke's Hospital Cancer Care Center
Fairview Southdale Hospital
Mercy and Unity Cancer Center at Unity Hospital
Immanuel St. Joseph's
HealthEast Cancer Care at St. John's Hospital
Minnesota Oncology Hematology, PA - Maplewood
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Hennepin County Medical Center - Minneapolis
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Mayo Clinic Cancer Center
CentraCare Clinic - River Campus
Coborn Cancer Center
CCOP - Metro-Minnesota
Park Nicollet Cancer Center
Regions Hospital Cancer Care Center
United Hospital
St. Francis Cancer Center at St. Francis Medical Center
Ridgeview Medical Center
Minnesota Oncology Hematology, PA - Woodbury
Saint Francis Medical Center
St. John's Regional Medical Center
Kansas City Cancer Centers - South
Kansas City Cancer Centers - North
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
CCOP - St. Louis-Cape Girardeau
David C. Pratt Cancer Center at St. John's Mercy
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
CCOP - Montana Cancer Consortium
Northern Rockies Radiation Oncology Center
Billings Clinic - Downtown
Bozeman Deaconess Cancer Center
Big Sky Oncology
Great Falls Clinic - Main Facility
Sletten Cancer Institute at Benefis Healthcare
Methodist Estabrook Cancer Center
CCOP - Nevada Cancer Research Foundation
Saint Mary's Regional Medical Center
Radiation Oncology Associates - Reno
Dartmouth - Hitchcock Concord
Center for Cancer Care at Exeter Hospital
Kingsbury Center for Cancer Care at Cheshire Medical Center
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Cancer Institute of New Jersey at Cooper University Hospital - Camden
CentraState Medical Center
Princeton Radiation Oncology Center
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
Newark Beth Israel Medical Center
University Medical Center at Princeton
Frederick R. and Betty M. Smith Cancer Treatment Center
Capital Health Regional Cancer Center
Cancer Institute of New Jersey at Cooper - Voorhees
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Lovelace Medical Center - Downtown
University of New Mexico Cancer Center
New York Oncology Hematology, PC at Albany Regional Cancer Care
Lourdes Regional Cancer Center
Roswell Park Cancer Institute
CCOP - Hematology-Oncology Associates of Central New York
Cayuga Medical Center of Ithaca
CCOP - North Shore University Hospital
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Long Island Jewish Medical Center
NYU Cancer Institute at New York University Medical Center
Hudson Valley Oncology Associates
Saint Francis Hospital Cancer Center
Highland Hospital of Rochester
James P. Wilmot Cancer Center at University of Rochester Medical Center
Duke Comprehensive Cancer Center
CaroMont Cancer Center at Gaston Memorial Hospital
Wayne Memorial Hospital, Incorporated
Wayne Radiation Oncology
Bismarck Cancer Center
Medcenter One Hospital Cancer Care Center
Mid Dakota Clinic, PC
St. Alexius Medical Center Cancer Center
CCOP - MeritCare Hospital
MeritCare Broadway
McDowell Cancer Center at Akron General Medical Center
Summa Center for Cancer Care at Akron City Hospital
Barberton Citizens Hospital
Charles M. Barrett Cancer Center at University Hospital
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland Clinic Taussig Cancer Center
Cleveland Clinic Cancer Center
Hillcrest Cancer Center at Hillcrest Hospital
Cancer Care Center, Incorporated
Precision Radiotherapy at University Pointe
Cancer Treatment Center
Cleveland Clinic - Wooster
Oklahoma University Cancer Institute
Willamette Valley Cancer Center - Eugene
Celilo Cancer Center at Mid-Columbia Medical Center
Rosenfeld Cancer Center at Abington Memorial Hospital
Bryn Mawr Hospital
Geisinger Cancer Institute at Geisinger Health
Mercy Fitzgerald Hospital
Northeast Radiation Oncology Center
St. Mary Regional Cancer Center
Upper Delaware Valley Cancer Center
Cancer Center of Paoli Memorial Hospital
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Fox Chase Cancer Center - Philadelphia
Frankford Hospital Cancer Center - Torresdale Campus
MNAP Oncologic Center
Fox Chase Cancer Center CCOP Research Base
Albert Einstein Cancer Center
Guthrie Cancer Center at Guthrie Clinic Sayre
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
CCOP - Main Line Health
Lankenau Cancer Center at Lankenau Hospital
York Cancer Center at Apple Hill Medical Center
Carolina Regional Cancer Center
CCOP - Upstate Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Rapid City Regional Hospital
Texas Oncology, PA at Harris Center HEB
St. Joseph Regional Cancer Center
Medical City Dallas Hospital
Texas Oncology, PA at Texas Cancer Center Dallas Southwest
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
University of Texas Health Science Center at San Antonio
Cancer Therapy and Research Center
Texas Oncology, PA at Texas Cancer Center - Sherman
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sandra L. Maxwell Cancer Center
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Utah Valley Regional Medical Center - Provo
Dixie Regional Medical Center - East Campus
Utah Cancer Specialists at UCS Cancer Center
Huntsman Cancer Institute at University of Utah
LDS Hospital
Fletcher Allen Health Care - University Health Center Campus
Community Cancer Center at Rutland Regional Medical Center
Norris Cotton Cancer Center - North
INOVA Alexandria Hospital
Danville Regional Medical Center
Sentara Cancer Institute at Sentara Norfolk General Hospital
Naval Medical Center - Portsmouth
Veterans Affairs Medical Center - Richmond
Harrison Medical Center
St. Francis Hospital
Good Samaritan Cancer Center
Franciscan Cancer Center at St. Joseph Medical Center
CCOP - Northwest
MultiCare Regional Cancer Center at Tacoma General Hospital
West Virginia University Health Sciences Center - Charleston
Theda Care Cancer Institute
Franciscan Skemp Healthcare - La Crosse Campus
Community Memorial Hospital Cancer Care Center
Columbia Saint Mary's Hospital - Ozaukee
Columbia-Saint Mary's Cancer Care Center
Medical College of Wisconsin Cancer Center
Veterans Affairs Medical Center - Milwaukee
All Saints Cancer Center at Wheaton Franciscan Healthcare
Welch Cancer Center at Sheridan Memorial Hospital
British Columbia Cancer Agency - Centre for the Southern Interior
BCCA - Fraser Valley Cancer Centre
British Columbia Cancer Agency - Vancouver Cancer Centre
British Columbia Cancer Agency - Vancouver Island Centre
Saint John Regional Hospital
Nova Scotia Cancer Centre
Margaret and Charles Juravinski Cancer Centre
London Regional Cancer Program at London Health Sciences Centre
Cancer Care Program at Thunder Bay Regional Health Sciences
Hopital Notre-Dame du CHUM
McGill Cancer Centre at McGill University
Centre Hospitalier Universitaire de Quebec
Allan Blair Cancer Centre at Pasqua Hospital
Saskatoon Cancer Centre at the University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional 3D-CRT

Hypofractionated 3D-CRT

Arm Description

Conventional 3D-CRT or IMRT to 73.8 Gy in 41 fractions

Hypofractionated 3D-CRT or IMRT to 70 Gy in 28 fractions

Outcomes

Primary Outcome Measures

Five-year Disease-free Survival (DFS) Rate

Five-year rates are estimated by the Kaplan-Meier method. DFS events included local progression, distant metastatic progression, biochemical recurrence as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, or death from any cause. Patients who experienced second primary cancers remained under observation for DFS events.

Secondary Outcome Measures

Five-year Local Progression Rate

Clinical criteria for local recurrence are progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by 2 years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local recurrence are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than 2 years after the start of treatment. The arms were not statistically compared because of an insufficient number of events.

Five-year Disease-specific Survival Rate

An event was death in association with any of the following conditions: Primary cause of death certified as due to prostate cancer Further clinical tumor progression occurring after initiation of "salvage" anti-tumor (e.g., (androgen suppression) therapy A rise (that exceeds 1.0 ng/mL) in the serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after "salvage" androgen suppression therapy Disease progression in the absence of any anti-tumor therapy Death from a complication of therapy, irrespective of disease status. The arms were not statistically compared because of an insufficient number of events.

Five-year PSA Failure Rate

Five-year rates are shown (cumulative incidence estimates). Note, although the protocol calls this endpoint "Freedom from biochemical recurrence", it defines the endpoint as "The time to PSA failure". An event for PSA, i.e. biochemical, failure was the first of the following: initiation of non-protocol (e.g., salvage) hormone therapy, or an increase in PSA of at least 2 ng/mL. Time to biochemical failure was measured from study entry until the date of failure.

Five-year Overall Survival Rate

Five-year rates Kaplan-Meier estimates. Overall survival (OS) was measured from study entry until the date of death. Patients still alive at the time of analysis were censored at the date of last follow-up

Frequency of Patients With GU and GI Acute and Late Toxicity

The frequency of genitourinary (GU) and gastrointestinal (GI) adverse events as defined and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3) were compared between treatment arms. Acute toxicity was defined as any toxicity beginning within 90 days of completion of RT, and late toxicity was defined as any toxicity beginning more than 90 days after the completion of RT. Acute and late GU and GI toxicity rates were tabulated and reported in two ways: dichotomized as < grade 2 vs ≥ grade 2, and dichotomized as < grade 3 vs ≥ grade 3. Higher grade indicates more severity.

Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC

Prostate cancer (PC) Health-Related Quality of Life (HRQOL) outcomes as measured by change over time in the Expanded Prostate Cancer Index Composite [EPIC], a PC HRQOL instrument measuring a broad spectrum of urinary, bowel, and sexual symptoms related to radiotherapy, is compared between arms. The EPIC questionnaire was grouped into four domains (bowel, urinary, sexual, hormonal), each with a score ranging from 0 (worst) to 100 (best), and was assessed at baseline, 6, 12, and 24 months, and 5 years. The difference in score from baseline to each time point was calculated and the Wilcoxon test statistic was used to test the null hypothesis that responses are the same across the two treatment arms vs. the alternative hypothesis that they are different, using a 2-sided alpha of 0.05 at each timepoint, resulting in an alpha of 0.0125 for each domain. Each row refers to a separate analysis.

The Utilization of Sexual Medications/Devices Questionaire

The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The percentage of "Yes" responses to the following questions are reported: "Do you have a penile prosthesis", "Have you used an medications or devices to aid or improve erections?".

Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25

Anxiety and depression were measured with the Hopkins Symptom Checklist (HSCL-25). It consists of 25 items: Part I of the HSCL-25 has 10 items for anxiety symptoms; Part II has 15 items for depression symptoms. The scale for each question includes four categories of response ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items and ranges from 0 to 100. A higher score indicates worse symptoms. The HSCL-25 tool was assessed at baseline, 6 months, 12 months, 24 months, and 5 years. For each patient, the change in score from baseline to the time point is calculated by subtracting the baseline value from the time point value.

EQ-5D Scores

The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 -Worst health stat and 1 -Best health state. A two-sided Wilcoxon test with alpha 0.05 was used due to the skewed, thus non-normal, nature of the data.

Assessment of Trade-off Between Disease-free Survival and Quality of Life.

To examine trade-offs between the survival time and QOL, we were to combine them for each patient into two single measurements: quality adjusted live year (QALY) and quality adjusted disease-free survival year (QADFSY). We were to use Glasziou's multiple health-state (Q-TWiST) models to use the repeated measures of EQ-5D.

Statistical Modeling of Genomic Biomarkers

Full Information

NCT ID

NCT00331773

First Posted

May 30, 2006

Last Updated

December 27, 2022

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI), NRG Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00331773

Brief Title

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

April 2006 (Actual)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI), NRG Oncology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional 3D-CRT

Arm Type

Active Comparator

Arm Description

Conventional 3D-CRT or IMRT to 73.8 Gy in 41 fractions

Arm Title

Hypofractionated 3D-CRT

Arm Type

Experimental

Arm Description

Hypofractionated 3D-CRT or IMRT to 70 Gy in 28 fractions

Intervention Type

Radiation

Intervention Name(s)

Conventional 3D-CRT or IMRT

Other Intervention Name(s)

3-dimensional conformal radiation therapy, Intensity-modulated radiation therapy (IMRT)

Intervention Description

Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated 3D-CRT or IMRT

Other Intervention Name(s)

Hypofractionated 3-dimensional conformal radiation therapy, Intensity-modulated radiation therapy (IMRT)

Intervention Description

Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.

Primary Outcome Measure Information:

Title

Five-year Disease-free Survival (DFS) Rate

Description

Time Frame