Trial Outcomes & Findings for Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer (NCT NCT00924313)

Last Updated: 2017-07-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

40 participants

Primary outcome timeframe

2 years

Results posted on

2017-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	11C-acetate for Prostate Cancer Patients 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	11C-acetate for Prostate Cancer Patients 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Overall Study not imaged due to failed tracer imaging	1

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	11C-acetate for Prostate Cancer Patients n=40 Participants 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=40 Participants
Age, Categorical <=18 years	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=40 Participants
Age, Categorical >=65 years	7 Participants n=40 Participants
Age, Continuous	58.97 years STANDARD_DEVIATION 6.11 • n=40 Participants
Sex: Female, Male Female	0 Participants n=40 Participants
Sex: Female, Male Male	40 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=40 Participants
Race (NIH/OMB) Asian	2 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	7 Participants n=40 Participants
Race (NIH/OMB) White	28 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=40 Participants
Region of Enrollment United States	40 participants n=40 Participants
Interval Between Magnetic Resonance Imaging and Prostatectomy	54 Days n=38 Participants • 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	10.5 Days n=38 Participants • 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.

PRIMARY outcome

Timeframe: 2 years

Population: One patient was not imaged because of failed tracer synthesis.

Outcome measures

Outcome measures
Measure	11C-acetate for Prostate Cancer Patients n=39 Participants 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate Tumor region	4.4 ng/mL Standard Deviation 2.05
Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate Non-tumorous region	2.1 ng/mL Standard Deviation 0.94

SECONDARY outcome

Timeframe: 2 years

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Outcome measures

Outcome measures
Measure	11C-acetate for Prostate Cancer Patients n=39 Participants 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Count of Participants With Adverse Events	14 Participants

SECONDARY outcome

Timeframe: 2 years

Population: One patient was not imaged because of failed tracer synthesis.

The diagnostic accuracy of 11C-Acetate PET/CT imaging in prostate cancer was compared with multi-parametric magnetic resonance imaging (MP-MRI) using sector based analysis, generating receiver-operating-characteristic (ROC) curves (plots of 1-specificity versus sensitivity) for both modalities.

Outcome measures

Outcome measures
Measure	11C-acetate for Prostate Cancer Patients n=38 Participants 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
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 PET specificity	80 Percentage ROC curve Interval 78.0 to 82.0
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 PET sensitivity	62 Percentage ROC curve Interval 59.0 to 65.0
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 MRI specificity	95 Percentage ROC curve Interval 92.0 to 97.0
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 MRI sensitivity	82.3 Percentage ROC curve Interval 79.0 to 85.0

SECONDARY outcome

Timeframe: 2 years

Population: One patient was not imaged because of failed tracer synthesis.

Pelvic biodistribution was obtained for the prostate tumor, normal prostate and benign prostatic hyperplasia (BPH). Uptake is expressed in standardized uptake value (SUV).

Outcome measures

Outcome measures
Measure	11C-acetate for Prostate Cancer Patients n=38 Participants 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging Prostate tumor	4.4 SUV Standard Deviation 2.05
Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging Normal tumor	2.1 SUV Standard Deviation 0.943
Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging Benign prostatic hyperplasia (BPH)	4.8 SUV Standard Deviation 2.01

SECONDARY outcome

Timeframe: 2 years

Population: One patient was not imaged because of failed tracer synthesis.

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.

Outcome measures

Outcome measures
Measure	11C-acetate for Prostate Cancer Patients n=38 Participants 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Count of Participants With Physiological Effects of [11C]AC	1 Participants

SECONDARY outcome

Timeframe: 2 years

Population: One patient was not imaged because of failed tracer synthesis.

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.

Outcome measures

Outcome measures
Measure	11C-acetate for Prostate Cancer Patients n=38 Participants 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection	1 Participants

SECONDARY outcome

Timeframe: 2 years

Population: One patient was not imaged because of failed tracer synthesis.

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.

Outcome measures

Outcome measures
Measure	11C-acetate for Prostate Cancer Patients n=38 Participants 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score Gleason scores 3+4 and below	4.2 SUV Standard Deviation 1.8
Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score Gleason scores 4+3 and above	4.9 SUV Standard Deviation 3.1

SECONDARY outcome

Timeframe: 2 years

Population: One patient was not imaged because of failed tracer synthesis.

PET/CT, MP-MRI, DW-MRI, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) were used to detect lesion sensitivity.

Outcome measures

Outcome measures
Measure	11C-acetate for Prostate Cancer Patients n=38 Participants 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
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. PET/CT	73.4 percentage of sensitivity Interval 70.0 to 75.0
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. MP-MRI	88.5 percentage of sensitivity Interval 82.0 to 92.0
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. DW-MRI	80 percentage of sensitivity Interval 76.0 to 85.0
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. DCE-MRI	55 percentage of sensitivity Interval 50.0 to 61.0

SECONDARY outcome

Timeframe: 2 years

Population: One patient was not imaged because of failed tracer synthesis.

Tumor foci was histopathologically identified and tested to determine SUVmax relative to PSA levels. PSA normal range is 0-4ng/mL.

Outcome measures

Outcome measures
Measure	11C-acetate for Prostate Cancer Patients n=38 Participants 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation PSA level <4 ng/ml	3.7 SUVmax Standard Deviation 2.0
11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation PSA level 4-10 ng/ml	4.9 SUVmax Standard Deviation 2.3
11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation PSA level >10ng/ml	5.1 SUVmax Standard Deviation 0.8

Adverse Events

11C-acetate for Prostate Cancer Patients

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	11C-acetate for Prostate Cancer Patients n=40 participants at risk 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
General disorders Constitutional Symptoms-Other (Specify, Funny smell)	2.5% 1/40 • Number of events 1 • 2 years
Gastrointestinal disorders Constipation	2.5% 1/40 • Number of events 1 • 2 years
Gastrointestinal disorders Nausea	2.5% 1/40 • Number of events 1 • 2 years
Gastrointestinal disorders Taste alteration (dysgeusia)	25.0% 10/40 • Number of events 10 • 2 years
Gastrointestinal disorders Vomiting	2.5% 1/40 • Number of events 1 • 2 years
Nervous system disorders Syncope (fainting)	2.5% 1/40 • Number of events 1 • 2 years
Musculoskeletal and connective tissue disorders Pain: Back	2.5% 1/40 • Number of events 1 • 2 years
Musculoskeletal and connective tissue disorders Pain: Extremity-limb	2.5% 1/40 • Number of events 1 • 2 years

Additional Information

Dr. Peter L. Choyke

National Cancer Institute, National Institutes of Health

Phone: 301-402-8409

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place