12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

Not Applicable

• Conditions: Prostate Cancer; Radiotherapy
• Interventions: Radiation: carbon ion radiotherapy

• Registration Number: NCT04724577
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

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.

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2021-01-23
• Study First Submitted QC: 2021-01-23
• Study First Posted: 2021-01-26
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-19
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carbon ion treatment	carbon ion radiotherapy	dose escalation study with five dose levels \[54GGyE(Gray equivalent)/12Fx,55.2GyE/12Fx,56.4GyE/12Fx,57.6GyE/12Fx and 58.8GyE/12Fx \].

Primary Outcome Measures

Name	Time	Method
Acute toxicity	3 months after the completion of CIRT	Treatment related acute toxicity assessed by CTCAE v4.03

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Proton and Heavy Ion Center; 🇨🇳 Shanghai, China