12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

Shanghai Proton and Heavy Ion Center30 enrolled

Overview

The arm of this study is to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer in our center.

The radiation dose of 51.6GyE in 12 fractions is currently widely used in Japan, and clinical studies of 51.6GyE/12Fx have also been carried out for SBRT. There are some differences in equipment and carbon ion treatment planning system used between Japan and our center. Therefore, we designed this phase I clinical study to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Radiotherapy Prostate Cancer

Interventions

carbon ion radiotherapyRADIATION

dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx

Eligibility

Sex: MALEMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologically confirmed adenocarcinoma of prostate * Stage cT1-3N0M0 localized prostate cancer * No lymph nodes or distant metastasis * Age ≥ 45 and \< 85 years of age * Karnofsky Performance Score ≥70 * No previous pelvic radiation therapy (RT) * No previous prostatectomy * No previous invasive cancer (within 5 years before the prostate cancer diagnosis) * Ability to understand character and individual consequences of the clinical trial * Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial Exclusion Criteria: * No pathologically confirmed adenocarcinoma of the prostate * Pelvic lymph node metastasis (N1) * Distant metastasis (M1) * Previous pelvic radiotherapy * Previous prostatectomy

Locations (1)

Shanghai Proton and Heavy Ion Center

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Acute toxicity

Treatment related acute toxicity assessed by CTCAE v4.03

Time frame: 3 months after the completion of CIRT

Secondary Outcomes

Biochemical failure free survival,bFFS

The PSA less than nadir plus 2ng/ml

Time frame: From the complation of CIRT,a median of 5 years

Overall survival

The time from diagnosis to death from any cause

Time frame: From the diagnosis of prostate cancer,a median of 5 years

Progression free survival

The time from complation of CIRT to tumor progression or death

Time frame: From the complation of CIRT,a median of 5 years

Data from ClinicalTrials.gov

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