Prostate Carcinoma
Conditions
Keywords
prostate carcinoma, carbon-ion radiotherapy, efficacy, toxicity
Brief summary
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
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.
Interventions
DEVICEcarbon-ion radiotherapy
Sponsors
Shanghai Proton and Heavy Ion Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
China
Contacts
Primary ContactPing Li, Dr.
Outcome results
None listed