Development of Clinical Assessment Technique Using Multi-radiotracer PET/MR in Prostate Cancer

Not Applicable

• Conditions: Prostate Cancer Recurrent; Stage II Prostate Carcinoma; Stage III Prostate Carcinoma

• Registration Number: NCT01938339
• Lead Sponsor: Seoul National University Hospital

Brief Summary

To development of clinical assessment technique using multi-radiotracer positron emission tomography/magnetic resonance (PET/MR) in prostate cancer

* to establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer

* to establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer and early detection of recurrent prostate cancer

Detailed Description

To establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer

* Recruiting 30 patients with prostate cancer ahead to radical prostatectomy

* PET/MR using 18F-choline with dedicated prostate MRI in all patients

* PET/MR using 18fluoride(F)-fluorodeoxyglucose(FDG)in all patients after 2-7 days

* PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR

* outcome assessment: comparison of scan time, image quality, tumor detection rate, standardized uptake values of lesions

* establishing optimal imaging technique for prostate PET/MR

To establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer

* comparison of findings on PET/MR, MRI and PET/CT with pathological mapping after radical prostatectomy

* outcome assessment: accuracy of PET/MR for localization and staging of prostate cancer compared with MRI only and PET/CT only

To establish the imaging biomarker using PET/MR for early detection of recurrent prostate cancer

* Recruiting 15 patients with recurrent prostate cancer treated by surgery, hormone, or radiation therapy

* Recruiting 15 patients with treated prostate cancer without recurrence

* PET/MR using 18F-choline with dedicated prostate MRI in all patients

* PET/MR using 18F-FDG in all patients after 2-7 days

* PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR

* comparison of findings on PET/MR, MRI, and PET/CT with clinical data in two patient groups with or without recurrent prostate cancer

* outcome assessment: accuracy of PET/MR for early detection and localization of recurrent prostate cancer compared with MRI only and PET/CT only

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-05
• Primary Completion: 2014-04
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• patient with prostate cancer before treatment
• patient with prostate cancer treated
• patient with prostate cancer recurrent

Exclusion Criteria

• patient with contraindication for MRI
• Patient with severe renal impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
accuracy of PET/MR predicting localization and staging of prostate cancer	1 week after radical prostatectomy	analysis of accuracy of PET/MR predicting localization and staging of prostate cancer by comparison of PET/MR findings with pathological mapping images after radical prostatectomy

Secondary Outcome Measures

Name	Time	Method
accuracy of early detection and localization of recurrent prostate cancer	1 week after PET/MR imaging	accuracy of PET/MR for early detection and localization of recurrence by comparison of PET/MR findings with clinical data in two groups of patients with or without recurrent prostate cancer

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of