Trial Outcomes & Findings for Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer (NCT NCT01867424)
NCT ID: NCT01867424
Last Updated: 2020-07-08
Results Overview
Uptake and retention of Eovist in prostate cancers is measured by the change of magnetic resonance imaging (MRI) parameter values between pre and post injection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline and 20 minutes, 40 minutes, and 60 minutes after Eovist injection
Results posted on
2020-07-08
Participant Flow
Participant milestones
| Measure |
Participants With Advanced Disease
Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
Participants With Localized Disease
Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Participants With Advanced Disease
Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
Participants With Localized Disease
Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
|---|---|---|
|
Overall Study
Patient noncompliance
|
2
|
1
|
Baseline Characteristics
Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer
Baseline characteristics by cohort
| Measure |
Participants With Advanced Disease
n=12 Participants
Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
Participants With Localized Disease
n=12 Participants
Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
Total
n=24 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
65.67 years
STANDARD_DEVIATION 10.59 • n=5 Participants
|
65.17 years
STANDARD_DEVIATION 7.30 • n=7 Participants
|
65.42 years
STANDARD_DEVIATION 8.90 • 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 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
|
1 Participants
n=7 Participants
|
1 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 20 minutes, 40 minutes, and 60 minutes after Eovist injectionPopulation: Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.
Uptake and retention of Eovist in prostate cancers is measured by the change of magnetic resonance imaging (MRI) parameter values between pre and post injection.
Outcome measures
| Measure |
Participants With Advanced Disease
n=9 Participants
Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
Participants With Localized Disease
n=10 Participants
Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
|---|---|---|
|
Uptake and Retention of Eovist in Prostate Cancers
60 minutes after Eovist
|
2.56 contrast enhancement ratio (CER)
Standard Deviation 1.45
|
2.06 contrast enhancement ratio (CER)
Standard Deviation 0.34
|
|
Uptake and Retention of Eovist in Prostate Cancers
Baseline
|
2.01 contrast enhancement ratio (CER)
Standard Deviation 1.16
|
1.857 contrast enhancement ratio (CER)
Standard Deviation 0.41
|
|
Uptake and Retention of Eovist in Prostate Cancers
20 minutes after Eovist
|
2.52 contrast enhancement ratio (CER)
Standard Deviation 1.26
|
2.212 contrast enhancement ratio (CER)
Standard Deviation 0.36
|
|
Uptake and Retention of Eovist in Prostate Cancers
40 minutes after Eovist
|
2.52 contrast enhancement ratio (CER)
Standard Deviation 1.39
|
2.05 contrast enhancement ratio (CER)
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: At baselinePopulation: Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.
Scans with or without endorectal coil were obtained through the prostate gland, bone metastasis or soft tissue metastasis (usually a lymph node) selected as the target lesion as described in primary outcome measure. Then 0.1 ml/kg Eovist was administered intravenously. Scans were correlated with baseline Gleason score obtained from the prostate biopsy. Gleason score \<7 = low grade cancer; Gleason score ≥7 = high grade cancer.
Outcome measures
| Measure |
Participants With Advanced Disease
n=9 Participants
Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
Participants With Localized Disease
n=10 Participants
Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
|---|---|---|
|
Number of Participants Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection With Respect to Gleason Score
Gleason score <7
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection With Respect to Gleason Score
Gleason score ≥7
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.
Scans with or without endorectal coil were obtained through the prostate gland, bone metastasis or soft tissue metastasis (usually a lymph node) selected as the target lesion as described in primary outcome measure. Then 0.1 ml/kg Eovist was administered intravenously. Scans were correlated to baseline PSA levels.
Outcome measures
| Measure |
Participants With Advanced Disease
n=9 Participants
Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
Participants With Localized Disease
n=10 Participants
Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
|---|---|---|
|
Baseline Serum Prostate-Specific Antigen (PSA) Levels of Patients Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection
|
163.17 ng/mL
Standard Deviation 208.50
|
11.46 ng/mL
Standard Deviation 13.15
|
SECONDARY outcome
Timeframe: From date treatment consent signed to date off study, approximately 3 years and 33 daysHere is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Participants With Advanced Disease
n=12 Participants
Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
Participants With Localized Disease
n=12 Participants
Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events
|
1 Participants
|
0 Participants
|
Adverse Events
Participants With Advanced Disease
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Participants With Localized Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants With Advanced Disease
n=12 participants at risk
Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
Participants With Localized Disease
n=12 participants at risk
Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.
Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • From date treatment consent signed to date off study, approximately 3 years and 33 days
|
0.00%
0/12 • From date treatment consent signed to date off study, approximately 3 years and 33 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place