Radiation Therapy in Treating Patients With Stage II Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Conventional 3D-CRT or IMRT; Hypofractionated 3D-CRT or IMRT
Intervention type(s): Radiation; Radiation
Intervention description(s): 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; 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.
Other intervention name(s): 3-dimensional conformal radiation therapy; Intensity-modulated radiation therapy (IMRT); Hypofractionated 3-dimensional conformal radiation therapy; Intensity-modulated radiation therapy (IMRT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer