PET-CT/MRI in the Radiotherapy for Prostate Cancer
Pilot Study of the Incorporation of PET-CT/MRI in the Radiotherapy for Prostate Cancer
1 other identifier
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 prostate-cancer
Started Sep 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedJune 29, 2016
June 1, 2016
2.9 years
June 23, 2016
June 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Solid tumor size
Three months after radiotherapy, the efficacy assessment for the prostate cancer will be examined with PET/CT or CT.
Three months
Secondary Outcomes (1)
Relapse-free survival
Three years
Other Outcomes (1)
Overall survival
Three years
Study Arms (3)
PET-CT
EXPERIMENTALPatients in this arm take radiotherapy positioning with PET-CT.
PET-MRI
EXPERIMENTALPatients in this arm take radiotherapy positioning with PET-MRI.
Computed Tomography
NO INTERVENTIONPatients in this arm take radiotherapy positioning with CT.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Longzhen Zhang, MD
Xuzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
June 23, 2016
First Posted
June 29, 2016
Study Start
September 1, 2016
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
June 29, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share