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Trial record 73 of 1450 for:    prostate cancer AND radiation

PET-CT/MRI in the Radiotherapy for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02816840
Recruitment Status : Unknown
Verified June 2016 by Longzhen Zhang, Xuzhou Medical University.
Recruitment status was:  Not yet recruiting
First Posted : June 29, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Longzhen Zhang, Xuzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: PET-CT Radiation: PET-MRI Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Incorporation of PET-CT/MRI in the Radiotherapy for Prostate Cancer
Study Start Date : September 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Relapse-free survival [ Time Frame: Three years ]

Other Outcome Measures:
  1. Overall survival [ Time Frame: Three years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816840


Contacts
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Contact: Longzhen Zhang, MD 15895236960 jsxzzlz@126.com
Contact: Yong Xin, MD 13013933168 deep369@163.com

Sponsors and Collaborators
Xuzhou Medical University
Investigators
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Principal Investigator: Longzhen Zhang, MD Xuzhou Medical University

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Responsible Party: Longzhen Zhang, professor, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT02816840     History of Changes
Other Study ID Numbers: XYFY2016-KL015-01
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Longzhen Zhang, Xuzhou Medical University:
prostate cancer
radiotherapy
PET-CT/MRI
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases