Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer
This trial is active, not recruiting.
|Sponsor||Fox Chase Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||June 2002|
|End date||December 2015|
|Trial size||307 participants|
|Trial identifier||NCT00062309, CDR0000304712, FCCC-02602, P30CA006927|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
76 Gy in 38 fractions
70.2 Gy in 26 fractions
Freedom from biochemical and/or disease failure rates
time frame: weekly during treatment, at 3 months, 6 months or 2 years then yearly
Male participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Clinical stage T1b-T3c disease - No clinical or radiographic evidence of metastasis - Prostate-specific antigen (PSA) less than 80 ng/mL - Gleason score at least 5 - One of the following criteria must be met: - PSA greater than 10 ng/mL - Gleason score greater than 6 - T2b or greater palpable disease - Three or more biopsy cores involved with a Gleason score of at least 5 PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - No other medical condition that would preclude study participation - No other active malignancy within the past 5 years except nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic leukemia) - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - No more than 4 months of prior androgen deprivation therapy - Neoadjuvant and adjuvant androgen deprivation therapy is allowed for high-risk disease only Radiotherapy - No prior pelvic radiotherapy Surgery - No prior or planned radical prostate surgery
|Official title||A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation|
|Principal investigator||Mark Buyyounouski, MD|
|Description||OBJECTIVES: - 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.|
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