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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbon ion treatment | Experimental | dose escalation study with five dose levels [54GGyE(Gray equivalent)/12Fx,55.2GyE/12Fx,56.4GyE/12Fx,57.6GyE/12Fx and 58.8GyE/12Fx ]. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon ion radiotherapy | Radiation | dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Treatment related acute toxicity assessed by CTCAE v4.03 | 3 months after the completion of CIRT |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Male patients with prostate cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Proton and Heavy Ion Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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dose escalation study for carbon ion radiotherapy in prostate cancer
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| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |