Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00062309|
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : March 3, 2016
RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: radiation therapy||Phase 3|
- Compare the efficacy of conventional intensity-modulated radiotherapy (IMRT) vs hypofractionated IMRT, in terms of freedom from biochemical failure in men with intermediate- to high-risk prostate cancer.
- Compare the local control, freedom from distant metastasis, and overall survival of patients treated with these regimens.
- Determine local failure, using biopsy of the prostate, when objective tests (prostate-specific antigen, ultrasound, and digital rectal exam) suggest relapse in these patients.
- Compare the extent of disease eradication using biopsy of the prostate at 2 years after therapy in these patients.
- Compare the quality of life of patients treated with these regimens.
- Determine the impact of these regimens on patient preferences and utilities.
OUTLINE: This is a randomized study. Patients are stratified according to pretreatment prostate-specific antigen (no greater than 10 ng/mL vs greater than 10 to 20 ng/mL vs greater than 20 ng/mL), Gleason score (5-7 vs 8-10), and risk status (high risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) 5 days a week for 7.5 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo hypofractionated IMRT 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
Patients with high-risk disease also undergo androgen deprivation therapy for 2 years.
Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 4 years.
Patients are followed at 3 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||307 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||May 2006|
Active Comparator: CIMRT
76 Gy in 38 fractions
|Radiation: radiation therapy|
70.2 Gy in 26 fractions
|Radiation: radiation therapy|
- Freedom from biochemical and/or disease failure rates [ Time Frame: weekly during treatment, at 3 months, 6 months or 2 years then yearly ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062309
|United States, Pennsylvania|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Principal Investigator:||Mark Buyyounouski, MD||Fox Chase Cancer Center|