The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy (CIRT) for the treatment of in Chinese localized prostate cancer
The purpose of this study is to determine the maximal tolerated dose (MTD) of CIRT in the treatment of localized prostate cancer and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 6 months after the completion of CIRT. Once the MTD for localized prostate cancer is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From the date of CIRT to 6 months after the completion of CIRT, up to 6 months
Overall survival of all patients
Time frame: From the diagnosis of localized prostate, a median of 2 years
biochemical failure-free survival,bFFS
Time frame: From the completion of CIRT, a median of 2 years
Progression-free survival of all patients
Time frame: From the completion of CIRT, a median of 2 years
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