CLINICAL TRIAL / NCT00331773

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Interventional
Active
NCT00331773

Eligibility Details Visit Clinicaltrials.gov

Contact Information

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.

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.

Eligibility Details

Gender
Male

Age Group
18 Years to 120 Years

Accepting Healthy Volunteers
No

DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: - 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 â‰¥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity) - No other severe, active comorbidity PRIOR CONCURRENT THERAPY: - 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