12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

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

Detailed Description
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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.

Official Title
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Phase I Study on Carbon Ion Radiotherapy in 12 Fractions for Localized Prostate Cancer

Conditions
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Radiotherapy, Prostate Cancer

Intervention / Treatment
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* Radiation: carbon ion radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: dose escalation study for carbon ion radiotherapy in prostate cancer
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbon ion treatment<br>dose escalation study with five dose levels [54GGyE(Gray equivalent)/12Fx,55.2GyE/12Fx,56.4GyE/12Fx,57.6GyE/12Fx and 58.8GyE/12Fx ]. | Radiation: carbon ion radiotherapy<br>* dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | Treatment related acute toxicity assessed by CTCAE v4.03 | 3 months after the completion of CIRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical failure free survival,bFFS | The PSA less than nadir plus 2ng/ml | From the complation of CIRT,a median of 5 years | 
| Overall survival | The time from diagnosis to death from any cause | 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 | From the complation of CIRT,a median of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized prostate cancer, carbon ion radiotherapy