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

Trial Information

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