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PET-CT/MRI in the Radiotherapy for Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
PET-CT
PET-MRI
Sponsored by
Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, radiotherapy, PET-CT/MRI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with pathologically confirmed prostate cancer
  • Staged with Ⅲ-Ⅳ prostate cancer
  • Aged from 18 to 65 years old
  • Quality of life score (Karnofsky performance score) > 70
  • No distant metastasis
  • No serious internal diseases may affect the treatment plan
  • No previous history of prostate radiation therapy
  • Patients must be able to understand and be willing to sign a written informed consent document.

Exclusion Criteria:

  • Distant metastasis
  • Accompanied by other malignancies
  • Previous history of prostate radiation therapy
  • Pregnant or lactating women
  • History of allergic reaction to iodinated, non-iodinated, and/or gadolinium contrast agents
  • Liver and kidney dysfunction
  • Pacemaker or other metallic devices that would prevent MRI imaging from being performed
  • Patients quit during the treatment or violate of the study protocol caused by other factors
  • Any reason that, in the option of the investigator, contraindicates that the patient participates in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    PET-CT

    PET-MRI

    Computed Tomography

    Arm Description

    Patients in this arm take radiotherapy positioning with PET-CT.

    Patients in this arm take radiotherapy positioning with PET-MRI.

    Patients in this arm take radiotherapy positioning with CT.

    Outcomes

    Primary Outcome Measures

    Solid tumor size
    Three months after radiotherapy, the efficacy assessment for the prostate cancer will be examined with PET/CT or CT.

    Secondary Outcome Measures

    Relapse-free survival

    Full Information

    First Posted
    June 23, 2016
    Last Updated
    June 28, 2016
    Sponsor
    Xuzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02816840
    Brief Title
    PET-CT/MRI in the Radiotherapy for Prostate Cancer
    Official Title
    Pilot Study of the Incorporation of PET-CT/MRI in the Radiotherapy for Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    August 2019 (Anticipated)
    Study Completion Date
    August 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xuzhou Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The trial is to explore new and effective techniques in the treatment of prostate cancer and evaluate the role of PET-CT / MRI played in radiotherapy. Intensity modulated radiation therapy(IMRT) is adopted with all patients and the efficacy assessment for the prostate cancer will be examined with PET / CT or CT in three months after radiotherapy.
    Detailed Description
    All participants judged to have prostate cancer with stage Ⅲ-Ⅳand considered able to conduct radiotherapy. 180 patients will be enrolled in the trial and randomly divided into three groups. Three arms are respectively treated with CT、18F-FDG PET/CT、18F-FDG PET/MRI. The images were passed in three-dimensional treatment planning system, using software manually fusion and reconstruction of PET and CT. All patients adopt IMRT for the radiotherapy with 70Gy-80Gy. Three months after radiotherapy, solid tumer size for the prostate cancer will be assesed with PET / CT or CT. Early radiation reactions are evaluated by the United States RTOG (RTOG) acute response evaluation criteria, and late radiation reaction are evaluated with RTOG and the European Radiation Therapy Oncology Organization (EORTC). Before and after radiotherapy treatment,the tumor-associated marker of PSA will be monitored and the patients are regularly followed-up in the next three years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    prostate cancer, radiotherapy, PET-CT/MRI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PET-CT
    Arm Type
    Experimental
    Arm Description
    Patients in this arm take radiotherapy positioning with PET-CT.
    Arm Title
    PET-MRI
    Arm Type
    Experimental
    Arm Description
    Patients in this arm take radiotherapy positioning with PET-MRI.
    Arm Title
    Computed Tomography
    Arm Type
    No Intervention
    Arm Description
    Patients in this arm take radiotherapy positioning with CT.
    Intervention Type
    Radiation
    Intervention Name(s)
    PET-CT
    Intervention Description
    Patients in this arm take radiotherapy positioning with PET-CT.
    Intervention Type
    Radiation
    Intervention Name(s)
    PET-MRI
    Intervention Description
    Patients in this arm take radiotherapy positioning with PET-MRI.
    Primary Outcome Measure Information:
    Title
    Solid tumor size
    Description
    Three months after radiotherapy, the efficacy assessment for the prostate cancer will be examined with PET/CT or CT.
    Time Frame
    Three months
    Secondary Outcome Measure Information:
    Title
    Relapse-free survival
    Time Frame
    Three years
    Other Pre-specified Outcome Measures:
    Title
    Overall survival
    Time Frame
    Three years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with pathologically confirmed prostate cancer Staged with Ⅲ-Ⅳ prostate cancer Aged from 18 to 65 years old Quality of life score (Karnofsky performance score) > 70 No distant metastasis No serious internal diseases may affect the treatment plan No previous history of prostate radiation therapy Patients must be able to understand and be willing to sign a written informed consent document. Exclusion Criteria: Distant metastasis Accompanied by other malignancies Previous history of prostate radiation therapy Pregnant or lactating women History of allergic reaction to iodinated, non-iodinated, and/or gadolinium contrast agents Liver and kidney dysfunction Pacemaker or other metallic devices that would prevent MRI imaging from being performed Patients quit during the treatment or violate of the study protocol caused by other factors Any reason that, in the option of the investigator, contraindicates that the patient participates in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Longzhen Zhang, MD
    Phone
    15895236960
    Email
    jsxzzlz@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yong Xin, MD
    Phone
    13013933168
    Email
    deep369@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Longzhen Zhang, MD
    Organizational Affiliation
    Xuzhou Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    PET-CT/MRI in the Radiotherapy for Prostate Cancer

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