NCT00331773CompletedPhase 3
A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer
Radiation Therapy Oncology Group590 sites in 1 country1,116 target enrollmentStarted: April 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,116
- Locations
- 590
- Primary Endpoint
- Five-year Disease-free Survival (DFS) Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Five-year Disease-free Survival (DFS) Rate
Time Frame: Analysis occurs after all patients have been followed for five years.
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 Outcomes
- Five-year Local Progression Rate(Analysis occurs after all patients have been followed for five years.)
- Five-year PSA Failure Rate(Analysis occurs after all patients have been followed for five years.)
- Frequency of Patients With GU and GI Acute and Late Toxicity(Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occured at the time of the primary endpoint analysis.)
- The Utilization of Sexual Medications/Devices Questionaire(Baseline, 6, 12, and 24 months, and 5 years)
- Assessment of Trade-off Between Disease-free Survival and Quality of Life.(From baseline to 5 years from the start of treatment)
- Five-year Disease-specific Survival Rate(Analysis occurs after all patients have been followed for five years.)
- Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25(Baseline, 6 months, 12 months, 24 months, and 5 years)
- EQ-5D Scores(Baseline, 6 months, 12 months, 24 months, and 5 years)
- Statistical Modeling of Genomic Biomarkers(Baseline biomarker collection. Analysis would occur after the primary endpoint analysis.)
- Five-year Overall Survival Rate(Analysis occurs after all patients have been followed for five years.)
- Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC(Baseline, 6, 12, and 24 months, and 5 years)
Investigators
Study Sites (590)
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