12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

Sponsor
Shanghai Proton and Heavy Ion Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04724577
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
42
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Radiation: carbon ion radiotherapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
dose escalation study for carbon ion radiotherapy in prostate cancerdose escalation study for carbon ion radiotherapy in prostate cancer
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study on Carbon Ion Radiotherapy in 12 Fractions for Localized Prostate Cancer
Actual Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Acute toxicity [3 months after the completion of CIRT]

    Treatment related acute toxicity assessed by CTCAE v4.03

Secondary Outcome Measures

  1. Biochemical failure free survival,bFFS [From the complation of CIRT,a median of 5 years]

    The PSA less than nadir plus 2ng/ml

  2. Overall survival [From the diagnosis of prostate cancer,a median of 5 years]

    The time from diagnosis to death from any cause

  3. Progression free survival [From the complation of CIRT,a median of 5 years]

    The time from complation of CIRT to tumor progression or death

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 85 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Shanghai Proton and Heavy Ion CenterShanghaiChina

Sponsors and Collaborators

  • Shanghai Proton and Heavy Ion Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ping Li, Principal Investigator, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier:
NCT04724577
Other Study ID Numbers:
  • SPHIC-TR-PCa2019-01
First Posted:
Jan 26, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ping Li, Principal Investigator, Shanghai Proton and Heavy Ion Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021