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This is a phase II randomized controlled clinical trial to assess the toxicities and clinical efficacy of prostate specific membrane antigen (PSMA) positron emission tomography / computed tomography (PET/CT) and multi- parameter Magnetic Resonance Imaging (MRI) guided simultaneous integrated boost for prostate cancer.
Local recurrences of prostate cancer following radiotherapy often originate from the primary tumor site. Therefore,focal boost to the primary gross tumor has been proposed to increase biochemical disease-free survival (bDFS) without increasing toxicity.
The higher relative biological effectiveness (RBE) and greater cytocidal effect on the intrinsic radiation resistant cancer cells offer carbon ion radiotherapy (CIRT) advantages over conventional radiotherapy. In this study, carbon ion were used to treat localized prostate cancer and simultaneous integrated boost to the gross tumor in the prostate specific membrane antigen (PSMA) PET/CT and multi- parameter MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carbon ion irradation group | Active Comparator | All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle |
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| Carbon Ion Irradiation With SIB group | Active Comparator | All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle, and with simultaneous integrated boost (SIB) to the gross tumor in the PSMA PET/CT and mpMRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon ion irradation | Radiation | All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicities | Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 | Within 3 months of the start of CIRT |
| Measure | Description | Time Frame |
|---|---|---|
| Late toxicities | Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale | 3 months after the completion of CIRT |
| Biochemical failure free survival | The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition) |
| Measure | Description | Time Frame |
|---|---|---|
| The quality of life-International Prostate Symptom Score (IPSS) | IPSS would be used to assess the severity of lower urinary tract symptoms, based on the answers to seven questions regarding urinary symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia). Total IPSS score: 1-7: Mild; 8-19: Moderate; 20-35: Severe | From the complation of CIRT, a median of 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Proton and Heavy Ion Center | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36348363 | Derived | Hu W, Li P, Hong Z, Guo X, Pei Y, Zhang Z, Zhang Q. Functional imaging-guided carbon ion irradiation with simultaneous integrated boost for localized prostate cancer: study protocol for a phase II randomized controlled clinical trial. Trials. 2022 Nov 8;23(1):934. doi: 10.1186/s13063-022-06798-5. |
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| Carbon Ion Irradiation With SIB | Radiation | All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle, and with simultaneous integrated boost (SIB) to the gross tumor in the PSMA PET/CT and mpMRI |
|
| 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 |
| The quality of life-Expanded Prostate Cancer Index Composite (EPIC) | EPIC would be used to evaluate the urinary, bowel, and sexual symptoms. The EPIC is a patient reported outcomes instrument designed to evaluate bowel, urinary, sexual and hormonal domains both during and after irradiation of the pelvis.For each domain, responses are provided on a 5-point Likert scale, and multi-item scale scores are transformed linearly to a scale of 0 to 100, where higher scores correspond to better quality of life. | From the complation of CIRT, a median of 5 years |