12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

Shanghai Proton and Heavy Ion Center

Status: Unknown

Conditions: Radiotherapy; Prostate Cancer

Treatments: Radiation: carbon ion radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04724577

SPHIC-TR-PCa2019-01

Details and patient eligibility

About

The arm of this study is to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer in our center.

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Carbon ion treatment

Experimental group

Description:

dose escalation study with five dose levels \[54GGyE(Gray equivalent)/12Fx,55.2GyE/12Fx,56.4GyE/12Fx,57.6GyE/12Fx and 58.8GyE/12Fx \].

Treatment:

Radiation: carbon ion radiotherapy