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The Role of C-11 Choline PET in Patients With 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: NCT02852122
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Tzu-Chen Yen, Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE July 8, 2015
First Posted Date  ICMJE August 2, 2016
Last Update Posted Date January 4, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of C-11 Choline PET in Patients With Prostate Cancer
Official Title  ICMJE The Role of C-11 Choline PET in Patients With Prostate Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Latent Cancer Prostate
Intervention  ICMJE Drug: 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.
Study Arms  ICMJE Experimental: C-11 choline
Intervention: Drug: C-11 choline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2016)
54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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)
  2. Age equals or more than 20 years old
  3. Willing to sign the informed consent

Exclusion Criteria:

  1. Patients with a concomitant or previous malignancy history
  2. 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
  3. Unable to give informed consent
  4. Previous allergy to carbon-labelled radionuclide
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02852122
Other Study ID Numbers  ICMJE 102-3271A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tzu-Chen Yen, Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP