12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

November 12, 2021 updated by: Ping Li, Shanghai Proton and Heavy Ion Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Proton and Heavy Ion Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 ].
Radiation: carbon ion radiotherapy
dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicity
Time Frame: 3 months after the completion of CIRT
Treatment related acute toxicity assessed by CTCAE v4.03
3 months after the completion of CIRT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical failure free survival,bFFS
Time Frame: From the complation of CIRT,a median of 5 years
The PSA less than nadir plus 2ng/ml
From the complation of CIRT,a median of 5 years
Overall survival
Time Frame: From the diagnosis of prostate cancer,a median of 5 years
The time from diagnosis to death from any cause
From the diagnosis of prostate cancer,a median of 5 years
Progression free survival
Time Frame: From the complation of CIRT,a median of 5 years
The time from complation of CIRT to tumor progression or death
From the complation of CIRT,a median of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Proton and Heavy Ion Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 23, 2021

First Submitted That Met QC Criteria

January 23, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPHIC-TR-PCa2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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