Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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 kill more tumor cells and have fewer side effects. It is not yet known which radiation therapy regimen is more 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.

Further Study Information

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 Criteria

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

• No PSA measurement for ≥ 10 days after prostate biopsy

• No PSA measurement for ≥ 30 days after discontinuation of finasteride (90 days after discontinuation 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 ≥ 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

W. Robert Lee

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00331773
Information obtained from ClinicalTrials.gov on November 20, 2012

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