PET-CT/MRI in the Radiotherapy for Prostate Cancer

NCT ID: NCT02816840

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-08-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PET-CT

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

Group Type: EXPERIMENTAL

PET-CT

Intervention Type: RADIATION

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

PET-MRI

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

Group Type: EXPERIMENTAL

PET-MRI

Intervention Type: RADIATION

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

Computed Tomography

Patients in this arm take radiotherapy positioning with CT.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PET-CT

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

Intervention Type: RADIATION

PET-MRI

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Longzhen Zhang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Longzhen Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Xuzhou Medical University

Central Contacts

Longzhen Zhang, MD

Role: CONTACT

jsxzzlz@126.com

15895236960

Yong Xin, MD

Role: CONTACT

deep369@163.com

13013933168

Other Identifiers

XYFY2016-KL015-01

Identifier Type: -

Identifier Source: org_study_id