12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase I Study on Carbon Ion Radiotherapy in 12 Fractions for Localized Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724577
• Other study ID #: SPHIC-TR-PCa2019-01
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy

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