search
Back to results

12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

Primary Purpose

Radiotherapy, Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
carbon ion radiotherapy
Sponsored by
Shanghai Proton and Heavy Ion Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiotherapy focused on measuring localized prostate cancer, carbon ion radiotherapy

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Shanghai Proton and Heavy Ion CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carbon ion treatment

Arm 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 ].

Outcomes

Primary Outcome Measures

Acute toxicity
Treatment related acute toxicity assessed by CTCAE v4.03

Secondary Outcome Measures

Biochemical failure free survival,bFFS
The PSA less than nadir plus 2ng/ml
Overall survival
The time from diagnosis to death from any cause
Progression free survival
The time from complation of CIRT to tumor progression or death

Full Information

First Posted
January 23, 2021
Last Updated
November 12, 2021
Sponsor
Shanghai Proton and Heavy Ion Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04724577
Brief Title
12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer
Official Title
Phase I Study on Carbon Ion Radiotherapy in 12 Fractions for Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy, Prostate Cancer
Keywords
localized prostate cancer, carbon ion radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
dose escalation study for carbon ion radiotherapy in prostate cancer
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carbon ion treatment
Arm Type
Experimental
Arm 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 ].
Intervention Type
Radiation
Intervention Name(s)
carbon ion radiotherapy
Intervention Description
dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx
Primary Outcome Measure Information:
Title
Acute toxicity
Description
Treatment related acute toxicity assessed by CTCAE v4.03
Time Frame
3 months after the completion of CIRT
Secondary Outcome Measure Information:
Title
Biochemical failure free survival,bFFS
Description
The PSA less than nadir plus 2ng/ml
Time Frame
From the complation of CIRT,a median of 5 years
Title
Overall survival
Description
The time from diagnosis to death from any cause
Time Frame
From the diagnosis of prostate cancer,a median of 5 years
Title
Progression free survival
Description
The time from complation of CIRT to tumor progression or death
Time Frame
From the complation of CIRT,a median of 5 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients with prostate cancer
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Li
Phone
38296666
Email
ping.li@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Qing Zhang
Phone
38296666
Email
qing.zhang@sphic.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

We'll reach out to this number within 24 hrs