- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02852122
The Role of C-11 Choline PET in Patients With Prostate Cancer
Study Overview
Detailed Description
[11C] choline positron emission tomography (PET) is an emerging modality for staging at initial diagnosis or re-staging at the time of treatment failure. The updated study shows 11C -labeled choline derivatives seem to be the most promising PET radionuclides in assessment of prostate cancer and USA FDA approves the utility of C-11 Choline in prostate cancer patients in 2012 September.
To our best literature search, there are only few preliminary studies regarding application of PET/MR in prostate cancer patients and the initial results in correlation of functional MRI and PET images seems promising. Combined PET/MRI images have the advantage of giving anatomical, functional, and metabolic information in a single image setting and provide a comprehensive survey including local regional extension and systemic metastasis. Unlike in the USA where more than 70% prostate cancer patients were diagnosed at early stage, most prostate cancer patients in Taiwan were diagnosed at advanced stage with high PSA or T3-4 disease, or even systemic metastasis. The need to implement good staging modality is even more urgently needed in Taiwan than in USA and related studies are still lacking. In the current study, our hypothesis is that C-11 Choline PET/MRI is a good modality in staging high risk prostate cancer patients, and in predicting patients' outcome after treatment. Our hypothesis will be examined by this clinical study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinically suspicious and/or pathology-proved high risk group prostate cancer patients (PSA > 20 ng/mL, or Gleason score 8-10, or clinical stage >T2c)
- Age equals or more than 20 years old
- Willing to sign the informed consent
Exclusion Criteria:
- Patients with a concomitant or previous malignancy history
- Unable to tolerate MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears, hip prosthesis), claustrophobia, unable to lie still
- Unable to give informed consent
- Previous allergy to carbon-labelled radionuclide
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: C-11 choline
|
This is an uncontrolled, open-labeled, non-randomized, prospective study.
The study duration is expected to be completed in a period of 2 years.
Up to 54 patients with primary prostate cancer and stratified as high risk group (PSA > 20 ng/mL, or Gleason score 8-10, or clinical stage >T2c) would be included.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Role of C-11 Choline PET in Patients with Prostate Cancer
Time Frame: Two years
|
Inconsistence rate (%) of C-11 Choline PET and MRI in detecting local regional and distant metastasis prostate cancer.
The inconsistence rate (%) is defined as the proportion of inconsistent results by PET and MRI, i. e. PET positive but MRI negative, or PET negative but MRI positive.
|
Two years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102-3271A
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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