Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Device: carbon-ion radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed adenocarcinoma of the prostate No lymph node and distant metastasis Age ≥ 20 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)except for skin non-melanoma cancer 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) Urinary obstructive symptoms (IPSS > 20) Previous pelvic radiotherapy Previous prostatectomy Severe systemic disorders Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin) Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer Non conformity of the radiotherapy dose distribution when compared to the dose constraints Psychiatric disorders or any other condition that can make unreliable the informed consent

Ages Eligible for Study
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Minimum Age: 20 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carbon-ion radiotherapy<br>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. | Device: carbon-ion radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Progression-free survival of all patients |  | From the completion of CIRT, a median of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate carcinoma, carbon-ion radiotherapy, efficacy, toxicity