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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04724577
Other study ID # SPHIC-TR-PCa2019-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date June 1, 2023

Study information

Verified date November 2021
Source Shanghai Proton and Heavy Ion Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 85 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Radiation:
carbon ion radiotherapy
dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx

Locations

Country Name City State
China Shanghai Proton and Heavy Ion Center Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute toxicity Treatment related acute toxicity assessed by CTCAE v4.03 3 months after the completion of CIRT
Secondary Biochemical failure free survival,bFFS The PSA less than nadir plus 2ng/ml From the complation of CIRT,a median of 5 years
Secondary Overall survival The time from diagnosis to death from any cause From the diagnosis of prostate cancer,a median of 5 years
Secondary Progression free survival The time from complation of CIRT to tumor progression or death From the complation of CIRT,a median of 5 years
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