The Role of C-11 Choline PET in Patients With Prostate Cancer
Primary Purpose
Latent Cancer Prostate
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
C-11 choline
Sponsored by
About this trial
This is an interventional diagnostic trial for Latent Cancer Prostate focused on measuring prostate cancer, C11 Choline PET/MR, staging, biochemical failure
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C-11 choline
Arm Description
Outcomes
Primary Outcome Measures
The Role of C-11 Choline PET in Patients with Prostate Cancer
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02852122
First Posted
July 8, 2015
Last Updated
January 3, 2017
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02852122
Brief Title
The Role of C-11 Choline PET in Patients With Prostate Cancer
Official Title
The Role of C-11 Choline PET in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators determine the target number as 54 patients based on the following reasons: (a) The bony metastasis rate for the high risk prostate cancer patients with PSA from 20 to 99.9 ng/ml was 21% (166/767 cases in a systemic review) [8]; the estimated sample size would be 47 under the condition of 20% more distant metastasis cases were identified by the PET/MRI scan using the 90% power, significance level of 0.05 and one sample proportion test. Assuming a dropout rate of 10%, the final ideal sample size is 52 patients. (b) The newly diagnostic number for the high risk prostate cancer patients in our hospital annually is ~70, about 6 patients a month. It is clinically feasible to recruit 3 patients a month until 18 months since the study begin. The study could be completed in 2 years with 54 cases
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Cancer Prostate
Keywords
prostate cancer, C11 Choline PET/MR, staging, biochemical failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C-11 choline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
C-11 choline
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Role of C-11 Choline PET in Patients with Prostate Cancer
Description
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.
Time Frame
Two years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
The Role of C-11 Choline PET in Patients With Prostate Cancer
We'll reach out to this number within 24 hrs