Trial Outcomes & Findings for Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer (NCT NCT02260817)
NCT ID: NCT02260817
Last Updated: 2019-12-17
Results Overview
The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. This Outcome is only measured for Arm 2 of this study. True Positive: True positives will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images confirmed with biopsy, surgical pathology, or by response to treatment with androgen suppression or other medical or radiation therapy. True Negative: True negatives will consist of negative images. False Positive: False positive will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images, but without corresponding confirmation from biopsy, surgical pathology or response to treatment. False Negative: False negative will consist of negative images, but with positive biopsy, surgical pathology or a response to treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
109 participants
Primary outcome timeframe
After 11C-choline PET CT scan and MRI scans, approximately 1 day. If surgery or response to treatment required to evaluate, approximately 1 to 3 months.
Results posted on
2019-12-17
Participant Flow
Recruitment dates: 10/14 - 6/16, dosage and imaging only at Decatur Memorial Hospital in Decatur, IL.
No enrolled participants were excluded from either arm of the study prior to assignment.
Participant milestones
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
95
|
|
Overall Study
COMPLETED
|
14
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
37
|
Reasons for withdrawal
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
14
|
|
Overall Study
Androgen deprivation therapy, no biopsy
|
0
|
7
|
|
Overall Study
Observation, no biopsy
|
0
|
1
|
|
Overall Study
Biopsy infeasible, ADT & rad. therapy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
14
|
Baseline Characteristics
Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
n=14 Participants
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=95 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 11C-choline PET CT scan and MRI scans, approximately 1 day. If surgery or response to treatment required to evaluate, approximately 1 to 3 months.Population: Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.
The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. This Outcome is only measured for Arm 2 of this study. True Positive: True positives will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images confirmed with biopsy, surgical pathology, or by response to treatment with androgen suppression or other medical or radiation therapy. True Negative: True negatives will consist of negative images. False Positive: False positive will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images, but without corresponding confirmation from biopsy, surgical pathology or response to treatment. False Negative: False negative will consist of negative images, but with positive biopsy, surgical pathology or a response to treatment.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=58 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Evidence of Metastatic Prostate Cancer
True Positive
|
0 Participants
|
36 Participants
|
|
Evidence of Metastatic Prostate Cancer
False Negative
|
0 Participants
|
1 Participants
|
|
Evidence of Metastatic Prostate Cancer
True Negative
|
0 Participants
|
10 Participants
|
|
Evidence of Metastatic Prostate Cancer
False Positive
|
0 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 day post-scan for patient resultsPopulation: Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.
The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging sensitivity. Sensitivity of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Negative). This Outcome is only measured for Arm 2 of this study.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=58 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Sensitivity of 11C Choline PET Imaging Scans
|
—
|
97.29 % of correctly identified positives
|
PRIMARY outcome
Timeframe: Approximately 1 day post-scan for patient resultsPopulation: Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.
The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging specificity. Specificity of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Positive). This Outcome is only measured and reported for Arm 2.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=58 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Specificity of 11C Choline PET Imaging Scans
|
—
|
47.61 % correctly identified negatives
|
PRIMARY outcome
Timeframe: Approximately 1 day post-scan for patient resultsPopulation: Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.
The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' positive predictive value. Positive Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Positive). This Outcome is only measured for Arm 2.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=58 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Positive Predictive Value (PPV) of 11C Choline PET Imaging Scans
|
—
|
76.59 Probability of disease (%)
|
PRIMARY outcome
Timeframe: Approximately 1 day post-scan for patient resultsPopulation: Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.
The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' negative predictive value. Negative Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Negative). This Outcome is only measured for Arm 2.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=58 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Negative Predictive Value (NPV) of 11C Choline PET Imaging Scans
|
—
|
90.90 Probability of being disease-free (%)
|
PRIMARY outcome
Timeframe: Approximately 1 day post-scan for patient resultsPopulation: This population only includes those Arm 2 participants with positive PET imaging.
Comparison of the results of participants' imaging modalities and whether those imaging modalities resulted in confirmation of Prostate Cancer (PCa). This Outcome is only measured for Arm 2.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=36 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation
Positive PET, Negative CT, Negative MRI
|
—
|
11 Participants
|
|
Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation
Positive PET, Positive CT, Negative MRI
|
—
|
6 Participants
|
|
Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation
Positive PET, Negative CT, Positive MRI
|
—
|
11 Participants
|
|
Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation
Positive PET, Positive CT, Positive MRI
|
—
|
8 Participants
|
SECONDARY outcome
Timeframe: The participants' age at primary treatment was collected upon study enrollment (approximately 1 week into study)Population: Only Arm 2 participants' data was collected.
The median age at primary treatment for Arm 2 participants.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=58 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Median Age at Primary Treatment
|
—
|
63 years
Interval 48.0 to 82.0
|
SECONDARY outcome
Timeframe: The participants' primary PSA at diagnosis was collected upon study enrollment (approximately 1 week into study)Population: Only Arm 2 participants' data was collected. \*Note: 4 participants' PSA was not reported.
The Prostate-Specific Antigen (PSA) measurement of participants at their original prostate cancer diagnosis was collected at entry to this trial. It is reported as nanograms of PSA per milliliter (ng/mL) of blood. The Median of all reported PSAs is reported here.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=54 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Median PSA at Diagnosis of Arm 2 Participants
|
—
|
13.07 ng/ml
Interval 1.29 to 105.0
|
SECONDARY outcome
Timeframe: The participants' clinical stage data was collected upon study enrollment (approximately 1 week into study)Population: Only data from Arm 2 participants' was collected. Note: Clinical Staging for 4 participants was not reported.
An accounting of the approximate clinical (pre-treatment) stage for the Arm 2 participants. Clinical staging is based on the results of tests done before surgery. T1: PC is too small to be seen on a scan or felt during prostate examination T1a: PC is in \< 5% of removed tissue T1b: PC is in \> 5% or more of removed tissue T1c: PC is found by biopsy T2: PC is completely inside prostate T2a: PC is in only half of one side of prostate T2b: PC is in more than half of one side of prostate, but not both sides T2c: PC is in both sides but is still inside prostate T3: PC has broken through the capsule of prostate T3a: PC has broken through the capsule of prostate T3b: PC has spread into seminal vesicles T4: PC has spread into other nearby body organs
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=54 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Clinical T (cT) Stage of Arm 2 Participants
cT Stage: T1c
|
0 Participants
|
34 Participants
|
|
Clinical T (cT) Stage of Arm 2 Participants
cT Stage: T2
|
0 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: The participants' primary Biopsy Gleason Score data was collected upon study enrollment (approximately 1 week into study)Population: Only data collected from Arm 2 Participants. Note: Biopsy Gleason Grade was not reported for 1 participant.
The median primary Biopsy Gleason Score for the Arm 2 participants' will be reported. The Gleason Score is the grading system used to determine the aggressiveness of prostate cancer. Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. Gleason scores 2-4 are typically found in smaller tumors located in the transitional zone (around the urethra). The majority of treatable/treated cancers are of Gleason scores 5 - 7 and are detected due to biopsy after abnormal digital rectal exam or prostate specific antigen evaluation. The cancer is typically located in the peripheral zone usually the posterior portion. Tumors with Gleason scores 8-10 tend to be advanced neoplasms that are unlikely to be cured.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=57 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Median Primary Biopsy Gleason Score of Arm 2 Participants
|
—
|
7 units on a scale
Interval 5.0 to 9.0
|
SECONDARY outcome
Timeframe: The participants' primary treatment data was collected upon study enrollment (approximately 1 week into study)Population: Only data collected from Arm 2 Participants.
An accounting of the primary treatment modalities undergone by the participants in Arm 2 prior to their involvement in the trial will be reported. Modalities reported below are: Androgen Deprivation Therapy (ADT) External Beam Radiation Therapy (EBRT) Brachytherapy Cryoablation Cystoprostatectomy Intensity-Modulated Radiation Therapy (IMRT) Radical Prostatectomy (RP)
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=58 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Primary Treatment Modality of Arm 2 Participants
ADT
|
—
|
1 Participants
|
|
Primary Treatment Modality of Arm 2 Participants
ADT + Brachytherapy
|
—
|
1 Participants
|
|
Primary Treatment Modality of Arm 2 Participants
ADT + EBRT + Brachytherapy
|
—
|
2 Participants
|
|
Primary Treatment Modality of Arm 2 Participants
Brachytherapy
|
—
|
4 Participants
|
|
Primary Treatment Modality of Arm 2 Participants
Brachytherapy + EBRT
|
—
|
1 Participants
|
|
Primary Treatment Modality of Arm 2 Participants
Cystoprostratectomy
|
—
|
1 Participants
|
|
Primary Treatment Modality of Arm 2 Participants
EBRT
|
—
|
10 Participants
|
|
Primary Treatment Modality of Arm 2 Participants
EBRT + ADT
|
—
|
3 Participants
|
|
Primary Treatment Modality of Arm 2 Participants
IMRT
|
—
|
1 Participants
|
|
Primary Treatment Modality of Arm 2 Participants
RP
|
—
|
34 Participants
|
SECONDARY outcome
Timeframe: The participants' primary pathological staging data was collected upon study enrollment (approximately 1 week into study)Population: Only data collected from Arm 2 participants. Note: Pathological Stage data not collected for 26 patients.
The pathological stage of PC at primary diagnosis for Arm 2 participants was collected. pT is based on how different from normal the cells in samples of tissue recovered from surgery look under a microscope. T1: PC is too small to be seen on a scan or felt during prostate examination T1a: PC is in \< 5% of removed tissue T1b: PC is in \> 5% or more of removed tissue T1c: PC is found by biopsy T2: PC is completely inside prostate T2a: PC is in only half of one side of prostate T2b: PC is in more than half of one side of prostate, but not both sides T2c: PC is in both sides but is still inside prostate T3: PC has broken through the capsule of prostate T3a: PC has broken through the capsule of prostate T3b: PC has spread into seminal vesicles T4: PC has spread into other nearby body organs
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=32 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants
pT2a
|
—
|
1 Participants
|
|
Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants
pT2c
|
—
|
14 Participants
|
|
Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants
pT3a
|
—
|
9 Participants
|
|
Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants
pT3b
|
—
|
8 Participants
|
SECONDARY outcome
Timeframe: The participants' primary surgical margins data was collected upon study enrollment (approximately 1 week into study)Population: Only data for Arm 2 participants was collected. Note: Primary Surgical Margins were not collected for 26 participants.
A census of the primary surgical margins of participants in Arm 2 will reported. The surgical margins are the set of surfaces that were cut by the surgeon in order to remove the specimen from the body. Positive Margin: surgical margins with disease present. Negative Margin: surgical margins with no disease present.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=32 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Primary Surgical Margins of Arm 2 Participants
Negative Surgical Margins
|
—
|
13 Participants
|
|
Primary Surgical Margins of Arm 2 Participants
Positive Surgical Margins
|
—
|
19 Participants
|
SECONDARY outcome
Timeframe: The participants' primary positive lymph note ratio was collected upon study enrollment (approximately 1 week into study)Population: Only data collected from Arm 2 participants. Note: Primary Positive Lymph Node Ratio was not collected for 26 participants.
A census of the positive lymph node ratio, defined as ratio of positive lymph nodes to all lymph nodes removed, for the participants of Arm 2 will be reported. The N refers to the the number of nearby lymph nodes that have cancer. NX: Cancer in nearby lymph nodes cannot be measured. N0: There is no cancer in nearby lymph nodes. N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=32 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Primary Positive Lymph Node Ratio of Arm 2 Participants
NX
|
—
|
3 Participants
|
|
Primary Positive Lymph Node Ratio of Arm 2 Participants
N0
|
—
|
25 Participants
|
|
Primary Positive Lymph Node Ratio of Arm 2 Participants
N1
|
—
|
4 Participants
|
SECONDARY outcome
Timeframe: The participants' additional primary treatment data was collected upon study enrollment (approximately 1 week into study)Population: only data from Arm 2 Participants is collected. Note: Additional Treatment was not reported for 1 participant.
A census of the additional treatments undergone by participants prior to enrollment in the study, if undergone, for the participants of Arm 2 will be reported. None Androgen Deprivation Therapy (ADT) Radiation Therapy (RT) Electron Beam Radiation Therapy (EBRT) Lycopene (herbal treatment) Salvage Radiation Therapy (RT) Salvage Radical Prostatectomy (RP) Adjuvant Radiation Therapy (RT) Bilateral Pelvis Lymph Node Dissection
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=57 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Additional Treatment and Type for Arm 2 Participants
ADT
|
—
|
11 Participants
|
|
Additional Treatment and Type for Arm 2 Participants
Adjuvant RT
|
—
|
3 Participants
|
|
Additional Treatment and Type for Arm 2 Participants
Bilateral Pelvis Lymph Node Dissection
|
—
|
1 Participants
|
|
Additional Treatment and Type for Arm 2 Participants
EBRT
|
—
|
1 Participants
|
|
Additional Treatment and Type for Arm 2 Participants
Lycopene
|
—
|
1 Participants
|
|
Additional Treatment and Type for Arm 2 Participants
None
|
—
|
31 Participants
|
|
Additional Treatment and Type for Arm 2 Participants
Salvage RP
|
—
|
1 Participants
|
|
Additional Treatment and Type for Arm 2 Participants
Salvage RT
|
—
|
5 Participants
|
|
Additional Treatment and Type for Arm 2 Participants
Salvage RT + ADT
|
—
|
3 Participants
|
SECONDARY outcome
Timeframe: The participants' biochemical relapse data was collected upon study enrollment (approximately 1 week into study)Population: only data from Arm 2 participants is collected. Note: Biochemical Relapse Data was not collected for 2 participants.
The median of the Arm 2 participants' data between initial treatment and biochemical relapse, occurring prior to study enrollment, measured in months, will be reported.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=56 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Median Months to Biochemical Relapse of Arm 2 Participants
|
—
|
40 months
Interval 2.0 to 197.0
|
SECONDARY outcome
Timeframe: The participants' age at study entry was collected upon study enrollment (approximately 1 week into study)Population: Only data collected from Arm 2 participants is reported.
The median age (at time of study) of participants of Arm 2 will be reported in years.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=58 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Median Age of Arm 2 Participant at PET Imaging
|
—
|
69 years
Interval 50.0 to 86.0
|
SECONDARY outcome
Timeframe: The participants' PSA was collected upon study enrollment (approximately 1 week into study)Population: only data collected for Arm 2 participants.
The median of the PSA of Arm 2 participants at study entry will be reported as nanograms of PSA per milliliter (ng/mL) of blood
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=58 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Median PSA of Arm 2 Participant at PET Imaging
|
—
|
3.58 ng/ml of blood
Interval 0.24 to 107.9
|
SECONDARY outcome
Timeframe: The participants' PSA doubling time was collected upon study enrollment (approximately 1 week into study)Population: Only data collected from Arm 2 participants is reported. Note: PSA doubling time (in months) was not collected for 3 participants.
The median of the time, measured in months that an Arm 2 participant's PSA has doubled from initial diagnosis to PSA measured at study enrollment.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=55 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Median PSA Doubling Time of Arm 2 Participants at PET Imaging
|
—
|
4.91 months
Interval 0.0 to 35.3
|
SECONDARY outcome
Timeframe: The participants' PSA velocity was collected upon study enrollment (approximately 1 week into study)Population: Only data collected from Arm 2 participants is reported. Note: PSA velocity was not collected for 3 participants.
The median PSA velocity (measured in ng/mL/month) of the Arm 2 participants will be reported.
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=55 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
Median PSA Velocity of Arm 2 Participants at PET Imaging
|
—
|
0.09 ng/mL/month
Interval 0.0 to 2.42
|
SECONDARY outcome
Timeframe: The participants' participation in ADT was collected upon study enrollment (approximately 1 week into study)Population: Only the Arm 2 participants data is reported. Note: ADT information was not collected for 2 participants.
An accounting of whether the participants of Arm 2 have undergone androgen deprivation therapy (ADT).
Outcome measures
| Measure |
11C-choline for Staging of Recurrent Prostate Cancer
The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.
|
11C-choline Comparison Study of CT and MR Modalities
n=56 Participants
11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
* 15 - millicuries (mCi) 11C-choline IV Injection
* PET images skull base to mid thigh with 3 min per bed position
* Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
* Fusion of PET and CT images
2\. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
* No IV contrast
* High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
* Fusion of coronal and PET images
|
|---|---|---|
|
ADT (Androgen Deprivation Therapy) in Participant at PET Imaging
No ADT received
|
—
|
48 Participants
|
|
ADT (Androgen Deprivation Therapy) in Participant at PET Imaging
ADT received
|
—
|
8 Participants
|
Adverse Events
11C-choline for Staging of Recurrent Prostate Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
11C-choline Comparison Study of CT and MR Modalities
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas H. Tarter, M.D., Ph.D - Director, Urologic Oncology, Cancer Care Specialists of Illinois
Decatur Memorial Hospital, Decatur, IL
Phone: (217) 876-6600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place