NCI Description

This dataset will allow users to reproduce the treatment comparison between arms in trial NCT00331773.

Clinical Trial Title

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

Trial Summary and Conditions

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.

Data Summary

See data dictionary for more details.

Study 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.

Outcome Measures

Primary: Five-year Disease-free Survival (DFS) Rate [ Time Frame: Analysis occurs after all patients have been followed for five years. ] Secondary: Five-year Local Progression Rate [ Time Frame: Analysis occurs after all patients have been followed for five years. ] Five-year Disease-specific Survival Rate [ Time Frame: Analysis occurs after all patients have been followed for five years. ] Five-year PSA Failure Rate [ Time Frame: Analysis occurs after all patients have been followed for five years. ] Five-year Overall Survival Rate [ Time Frame: Analysis occurs after all patients have been followed for five years. ] Frequency of Patients With GU and GI Acute and Late Toxicity [ Time Frame: 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. ] Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC [ Time Frame: Baseline, 6, 12, and 24 months, and 5 years ] The Utilization of Sexual Medications/Devices Questionaire [ Time Frame: Baseline, 6, 12, and 24 months, and 5 years ] Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25 [ Time Frame: Baseline, 6 months, 12 months, 24 months, and 5 years ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

• NCT00331773