PET-CT/MRI in the Radiotherapy for Prostate Cancer

June 28, 2016 updated by: Longzhen Zhang, Xuzhou Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PET-CT
Patients in this arm take radiotherapy positioning with PET-CT.
Radiation: PET-CT
Patients in this arm take radiotherapy positioning with PET-CT.
EXPERIMENTAL: PET-MRI
Patients in this arm take radiotherapy positioning with PET-MRI.
Radiation: PET-MRI
Patients in this arm take radiotherapy positioning with PET-MRI.
NO_INTERVENTION: Computed Tomography
Patients in this arm take radiotherapy positioning with CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Solid tumor size
Time Frame: Three months
Three months after radiotherapy, the efficacy assessment for the prostate cancer will be examined with PET/CT or CT.
Three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Relapse-free survival
Time Frame: Three years
Three years

Other Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Three years
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuzhou Medical University

Investigators

  • Principal Investigator: Longzhen Zhang, MD, Xuzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

August 1, 2019

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (ESTIMATE)

June 29, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2016-KL015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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