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Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00924313
Recruitment Status : Completed
First Posted : June 18, 2009
Results First Posted : August 17, 2012
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Choyke, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostate Cancer
Intervention Drug: (C-11 Acetate)
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Period Title: Overall Study
Started 40
Completed 39
Not Completed 1
Reason Not Completed
not imaged due to failed tracer imaging             1
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
33
  82.5%
>=65 years
7
  17.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
58.97  (6.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
0
   0.0%
Male
40
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Hispanic or Latino
4
  10.0%
Not Hispanic or Latino
36
  90.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  17.5%
White
28
  70.0%
More than one race
0
   0.0%
Unknown or Not Reported
3
   7.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
Interval Between Magnetic Resonance Imaging and Prostatectomy   [1] [2] 
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 38 participants
54
(2 to 155)
[1]
Measure Description: Prostatectomy is a partial or total removal of the prostate gland.
[2]
Measure Analysis Population Description: One patient was not imaged due to failed tracer synthesis. One patient was not evaluable due to inadequate registration between the transmission scan and magnetic resonance imaging.
Days to Radical Prostatectomy   [1] [2] 
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 38 participants
10.5
(1 to 34)
[1]
Measure Description: Radical prostatectomy is removal of the entire prostate gland. and additional tissue
[2]
Measure Analysis Population Description: One patient was not imaged due to failed tracer synthesis. One patient was not evaluable due to inadequate registration between the transmission scan and magnetic resonance imaging.
1.Primary Outcome
Title Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate
Hide Description Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was not imaged because of failed tracer synthesis.
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description:
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: ng/mL
Tumor region 4.4  (2.05)
Non-tumorous region 2.1  (0.94)
2.Secondary Outcome
Title Count of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description:
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Number of Participants Analyzed 39
Measure Type: Count of Participants
Unit of Measure: Participants
14
  35.9%
3.Secondary Outcome
Title Diagnostic Accuracy of the Standardized Uptake Value of [11C]AC Obtained Using Positron Emission Tomography (PET)/Computed Tomography (CT) for Detecting Region (Sextant)-Specific Malignancy Using Receiver Operating Curves (ROC) for a Lesion >0.9cm
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was not imaged because of failed tracer synthesis.
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description:
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage ROC curve
PET sensitivity
62
(59 to 65)
MRI sensitivity
82.3
(79 to 85)
PET specificity
80
(78 to 82)
MRI specificity
95
(92 to 97)
4.Secondary Outcome
Title Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging
Hide Description Pelvic biodistribution was obtained for the prostate tumor, normal prostate and benign prostatic hyperplasia (BPH). Uptake is expressed in standardized uptake value (SUV).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was not imaged because of failed tracer synthesis.
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description:
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: SUV
Prostate tumor 4.4  (2.05)
Normal tumor 2.1  (0.943)
Benign prostatic hyperplasia (BPH) 4.8  (2.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 11C-acetate for Prostate Cancer Patients
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The reported p-value is representative of the difference in levels of the histopathologic confirmed tumor and normal prostate tissue.
Method Spearman rank correlation
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 11C-acetate for Prostate Cancer Patients
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments The reported p-value is representative of the BPH high uptake level.
Method Spearman rank correlation
Comments [Not Specified]
5.Secondary Outcome
Title Count of Participants With Physiological Effects of [11C]AC
Hide Description Buildup of positron emission tomography (PET) radiopharmaceuticals excreted by the urinary system can accumulate in the bladder and limit pelvic imaging. This effect contributes to low physiologic distribution in the pelvis.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was not imaged because of failed tracer synthesis.
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description:
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.6%
6.Secondary Outcome
Title Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection
Hide Description Suspicious lesions noted on biopsy were compared with standard care imaging diagnostic modalities, additional biopsies, and/or clinical follow up performed at the discretion of the referring physician.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was not imaged because of failed tracer synthesis.
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description:
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.6%
7.Secondary Outcome
Title Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score
Hide Description Intensity [11C]AC uptake with histopathologic Gleason grade were done with a Spearman rank correlation following prostatectomy. Two biopsies were performed and graded according to tumor pattern. The two grades were added together for a final Gleason score. Gleason score equal to or less than 3+4 is considered low risk. Gleason score equal to or greater than 4+3 is considered high-risk.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was not imaged because of failed tracer synthesis.
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description:
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: SUV
Gleason scores 3+4 and below 4.2  (1.8)
Gleason scores 4+3 and above 4.9  (3.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 11C-acetate for Prostate Cancer Patients
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Spearman rank correlation
Comments [Not Specified]
8.Secondary Outcome
Title Lesion Based Sensitivity Analysis Using Positron Emission Tomography (PET)/Computed Tomography (CT), Multi-parametric Magnetic Resonance Imaging (MP-MRI), Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI), and DCE-MRI.
Hide Description PET/CT, MP-MRI, DW-MRI, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) were used to detect lesion sensitivity.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was not imaged because of failed tracer synthesis.
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description:
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of sensitivity
PET/CT
73.4
(70 to 75)
MP-MRI
88.5
(82 to 92)
DW-MRI
80
(76 to 85)
DCE-MRI
55
(50 to 61)
9.Secondary Outcome
Title 11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation
Hide Description Tumor foci was histopathologically identified and tested to determine SUVmax relative to PSA levels. PSA normal range is 0-4ng/mL.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient was not imaged because of failed tracer synthesis.
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description:
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: SUVmax
PSA level <4 ng/ml 3.7  (2.0)
PSA level 4-10 ng/ml 4.9  (2.3)
PSA level >10ng/ml 5.1  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 11C-acetate for Prostate Cancer Patients
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.407
Comments [Not Specified]
Method Spearman rank correlation
Comments [Not Specified]
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 11C-acetate for Prostate Cancer Patients
Hide Arm/Group Description 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
All-Cause Mortality
11C-acetate for Prostate Cancer Patients
Affected / at Risk (%)
Total   0/40 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
11C-acetate for Prostate Cancer Patients
Affected / at Risk (%) # Events
Total   0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
11C-acetate for Prostate Cancer Patients
Affected / at Risk (%) # Events
Total   14/40 (35.00%)    
Gastrointestinal disorders   
Constipation  1  1/40 (2.50%)  1
Nausea  1  1/40 (2.50%)  1
Taste alteration (dysgeusia)  1  10/40 (25.00%)  10
Vomiting  1  1/40 (2.50%)  1
General disorders   
Constitutional Symptoms-Other (Specify, Funny smell)  1  1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders   
Pain: Back  1  1/40 (2.50%)  1
Pain: Extremity-limb  1  1/40 (2.50%)  1
Nervous system disorders   
Syncope (fainting)  1  1/40 (2.50%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Peter L. Choyke
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-402-8409
EMail: pchoyke@mail.nih.gov
Layout table for additonal information
Responsible Party: Peter Choyke, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00924313     History of Changes
Obsolete Identifiers: NCT00771550
Other Study ID Numbers: 080226
08-C-0226
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: July 12, 2012
Results First Posted: August 17, 2012
Last Update Posted: July 11, 2017