Radiation Therapy in Treating Patients With Stage II Prostate Cancer

  • Interventional
  • Active
  • NCT00331773
Eligibility Details Visit Clinicaltrials.gov

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

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.



        - 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).


        - 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.


Age Group
18 Years to 120 Years

Accepting Healthy Volunteers?


         - 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


         - 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


         - 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

At a Glance

National Government IDNCT00331773


Lead SponsorRadiation Therapy Oncology Group

Lead PhysicianStanley Liauw


18 Years to 120 Years