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The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy (CIRT) for the treatment of in Chinese localized prostate cancer
The purpose of this study is to determine the maximal tolerated dose (MTD) of CIRT in the treatment of localized prostate cancer and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 6 months after the completion of CIRT. Once the MTD for localized prostate cancer is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carbon-ion radiotherapy | Experimental | Five dose levels [59.2 GyE(Gray equivalent)/16Fx, 60.8 GyE/16Fx, 62.4 GyE/16Fx, 64.0 GyE/16Fx and 65.6 GyE/16Fx] are planned within the Phase I part. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 65.6 GyE/16Fx are safely delivered, the recommended dose (or 65.6 GyE/16Fx) will be the prescribed dose in the Phase II part of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon-ion radiotherapy | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From the date of CIRT to 6 months after the completion of CIRT, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival of all patients | From the diagnosis of localized prostate, a median of 2 years | |
| biochemical failure-free survival，bFFS | From the completion of CIRT, a median of 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping Li, Dr. | Contact | ping.li@sphic.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qing Zhang, Dr. | Shanghai Proton and Heavy Ion Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Proton and Heavy Ion Center | Recruiting | Shanghai | Shanghai Municipality | 201321 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31164172 | Derived | Zhang Y, Li P, Yu Q, Wu S, Chen X, Zhang Q, Fu S. Preliminary exploration of clinical factors affecting acute toxicity and quality of life after carbon ion therapy for prostate cancer. Radiat Oncol. 2019 Jun 4;14(1):94. doi: 10.1186/s13014-019-1303-3. |
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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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| Progression-free survival of all patients |
| From the completion of CIRT, a median of 2 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |