PET-CT/MRI in the Radiotherapy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02816840
• Other study ID #: XYFY2016-KL015-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: June 23, 2016
• Last updated: June 28, 2016
• Start date: September 2016
• Est. completion date: August 2019

Study information

• Verified date: June 2016
• Source: Xuzhou Medical College
• Contact: Longzhen Zhang, MD
• Phone: 15895236960
• Email: jsxzzlz[@]126.com
• Is FDA regulated: No
• Health authority: China: Jiangsu Provincial Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with pathologically confirmed prostate cancer

• Staged with ?-? 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• PET-CT
Patients in this arm take radiotherapy positioning with PET-CT.
• PET-MRI
Patients in this arm take radiotherapy positioning with PET-MRI.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival		Three years	Yes
Primary	Solid tumor size	Three months after radiotherapy, the efficacy assessment for the prostate cancer will be examined with PET/CT or CT.	Three months	Yes
Secondary	Relapse-free survival		Three years	Yes