Radiotherapy, Prostate Cancer
Conditions
Keywords
localized prostate cancer, carbon ion radiotherapy
Brief summary
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
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.
Interventions
RADIATIONcarbon ion radiotherapy
dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx
Sponsors
Shanghai Proton and Heavy Ion Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
dose escalation study for carbon ion radiotherapy in prostate cancer
Eligibility
Sex/Gender
MALE
Age
45 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity | 3 months after the completion of CIRT | Treatment related acute toxicity assessed by CTCAE v4.03 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical failure free survival,bFFS | From the complation of CIRT,a median of 5 years | The PSA less than nadir plus 2ng/ml |
| Overall survival | From the diagnosis of prostate cancer,a median of 5 years | The time from diagnosis to death from any cause |
| Progression free survival | From the complation of CIRT,a median of 5 years | The time from complation of CIRT to tumor progression or death |
Countries
China
Outcome results
None listed