NCT02816840

PET-CT/MRI in the Radiotherapy for Prostate Cancer

Pilot Study of the Incorporation of PET-CT/MRI in the Radiotherapy for Prostate Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	PET-CT	Patients in this arm take radiotherapy positioning with PET-CT.
RADIATION	PET-MRI	Patients in this arm take radiotherapy positioning with PET-MRI.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2016-06-29
• Last updated: 2016-06-29