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12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

NCT ID: NCT04724577

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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Radiotherapy Prostate Cancer

Keywords

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localized prostate cancer carbon ion radiotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

dose escalation study for carbon ion radiotherapy in prostate cancer
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carbon ion treatment

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

Group Type EXPERIMENTAL

carbon ion radiotherapy

Intervention Type RADIATION

dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx

Interventions

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carbon ion radiotherapy

dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Proton and Heavy Ion Center

OTHER

Sponsor Role lead

Responsible Party

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Ping Li

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Proton and Heavy Ion Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Ping Li

Role: primary

Qing Zhang

Role: backup

Other Identifiers

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SPHIC-TR-PCa2019-01

Identifier Type: -

Identifier Source: org_study_id