To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
70 Gy in 28 fractions over 5.6 weeks
80Gy in 40 fractions over 8 weeks
Beijing Hospital
Beijing, China
RECRUITINGBiochemical progression free survival
Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure.
Time frame: up to 18 months
Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0
Time frame: From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT
Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0
Time frame: From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT
Overall Survival
Time frame: up to 5 years
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