Prostate Cancer
Conditions
Keywords
prostate cancer, radiotherapy, PET-CT/MRI
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.
Interventions
RADIATIONPET-CT
Patients in this arm take radiotherapy positioning with PET-CT.
RADIATIONPET-MRI
Patients in this arm take radiotherapy positioning with PET-MRI.
Sponsors
Xuzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solid tumor size | Three months | Three months after radiotherapy, the efficacy assessment for the prostate cancer will be examined with PET/CT or CT. |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival | Three years |
Other
| Measure | Time frame |
|---|---|
| Overall survival | Three years |
Contacts
Primary ContactLongzhen Zhang, MD
Backup ContactYong Xin, MD
Outcome results
None listed