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