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| ID | Type | Description | Link |
|---|---|---|---|
| 13-C-0145 |
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Background:
- Prostate cancer is the most common cancer type among men. Some prostate cancers respond to hormonal therapy. However, some cell characteristics of other prostate cancers cause it not to respond as well to these therapies. Researchers want to see if gadoxetate, a contrast agent used to help identify damaged liver tissue, can help tell these types of prostate cancer apart. It may be able to identify if a man has a type of prostate cancer for which hormone therapy may not work as well.
Objectives:
- To see if gadoxetate can help identify different types of prostate cancers during imaging studies.
Eligibility:
- Men at least 18 years of age who have prostate cancer. Participants will be having surgery to either remove the prostate or take tumor tissue samples.
Design:
BACKGROUND:
PRIMARY OBJECTIVE:
-Evaluate the uptake and retention of Eovist in prostate cancers.
ELIGIBILTY:
or
-Subjects, for whom tissue is not available, 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.
DESIGN:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Advanced Disease | Active Comparator | 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. |
|
| Participants with Localized Disease | Active Comparator | Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eovist | Drug | 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uptake and Retention of Eovist in Prostate Cancers | 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. | Baseline and 20 minutes, 40 minutes, and 60 minutes after Eovist injection |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection With Respect to Gleason Score | 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. |
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2.1.1.1 Subject is greater than or equal to 18 years old.
2.1.1.2 Subjects with clinically localized prostate cancer (outside pathology is acceptable) must have image guided biopsy confirmed prostate cancer and sufficient tissue available (obtained before or after 20 weeks of Eovist injection) for organic anion-transporting polypeptide 1B3 (OATP1B3) expression.
2.1.1.3 Subjects with advanced disease who have failed hormone therapy and who have sufficient tissue (obtained before or after 20 weeks of Eovist injection) from a soft tissue lesion (measuring greater than or equal to 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for OATP1B3 expression.
or
2.1.1.4 Subjects, for whom tissue is not available, 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.
2.1.1.5 Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
2.1.1.6 Serum creatinine within 3 weeks prior to Eovist MRI less than or equal to 1.8mg/dl and estimated glomerular filtration rate (eGFR) must be greater than 30 ml/min/1.73m(2).
2.1.1.7 Patients must have normal liver function as defined below:
2.1.1.8 Ability of subject to sign a written informed consent document
EXCLUSION CRITERIA:
2.1.2.1 Subjects with known hypersensitivity and allergy to gadolinium contrast agents
2.1.2.2 Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results
2.1.2.3 Subjects with severe claustrophobia unresponsive to oral anxiolytics
2.1.2.4 Subjects with contraindications to magnetic resonance imaging (MRI)
2.1.2.5 Subjects weighing greater than 136 kg (weight limit for scanner table)
2.1.2.6 Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI
2.1.2.7 Subjects with other medical conditions deemed by the principle investigator (or associates) to make the subject ineligible for protocol procedures
2.1.2.8 Subjects who will have a delay in clinically indicated radiation therapy due to the interval between Eovist MRI imaging and biopsy
2.1.1.1 Subject is greater than or equal to 18 years old.
2.1.1.2 Subjects with clinically localized prostate cancer (outside pathology is acceptable) must have image guided biopsy confirmed prostate cancer and sufficient tissue available (obtained before or after 20 weeks of Eovist injection) for organic anion-transporting polypeptide 1B3 (OATP1B3) expression.
2.1.1.3 Subjects with advanced disease who have failed hormone therapy and who have sufficient tissue (obtained before or after 20 weeks of Eovist injection) from a soft tissue lesion (measuring greater than or equal to 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for OATP1B3 expression.
or
2.1.1.4 Subjects, for whom tissue is not available, 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.
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| Name | Affiliation | Role |
|---|---|---|
| Ismail B Turkbey, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19404564 | Background | Narita M, Hatano E, Arizono S, Miyagawa-Hayashino A, Isoda H, Kitamura K, Taura K, Yasuchika K, Nitta T, Ikai I, Uemoto S. Expression of OATP1B3 determines uptake of Gd-EOB-DTPA in hepatocellular carcinoma. J Gastroenterol. 2009;44(7):793-8. doi: 10.1007/s00535-009-0056-4. Epub 2009 Apr 29. | |
| 20610543 | Background |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Uptake and Retention of Eovist in Prostate Cancers | 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. | Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images. | Posted | Mean | Standard Deviation | contrast enhancement ratio (CER) | Baseline and 20 minutes, 40 minutes, and 60 minutes after Eovist injection |
|
From date treatment consent signed to date off study, approximately 3 years and 33 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ismail Baris Turkbey | National Cancer Institute | 301-443-2315 | turkbey@nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 12, 2015 | Dec 20, 2017 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C073590 | gadolinium ethoxybenzyl DTPA |
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| At baseline |
| Baseline Serum Prostate-Specific Antigen (PSA) Levels of Patients Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection | 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. | Baseline |
| Number of Participants With Serious and Non-serious Adverse Events | Here 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. | From date treatment consent signed to date off study, approximately 3 years and 33 days |
| Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7. |
| 18519758 | Background | Hamada A, Sissung T, Price DK, Danesi R, Chau CH, Sharifi N, Venzon D, Maeda K, Nagao K, Sparreboom A, Mitsuya H, Dahut WL, Figg WD. Effect of SLCO1B3 haplotype on testosterone transport and clinical outcome in caucasian patients with androgen-independent prostatic cancer. Clin Cancer Res. 2008 Jun 1;14(11):3312-8. doi: 10.1158/1078-0432.CCR-07-4118. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
|
| Secondary | Number of Participants Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection With Respect to Gleason Score | 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. | Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images. | Posted | Count of Participants | Participants | At baseline |
|
|
|
| Secondary | Baseline Serum Prostate-Specific Antigen (PSA) Levels of Patients Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection | 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. | Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images. | Posted | Mean | Standard Deviation | ng/mL | Baseline |
|
|
|
|
| Secondary | Number of Participants With Serious and Non-serious Adverse Events | Here 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. | Posted | Count of Participants | Participants | From date treatment consent signed to date off study, approximately 3 years and 33 days |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | 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 | 0 | 12 | 0 | 12 | 0 | 12 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
|
Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 40 minutes post Eovist injection. |
| nonparametric Spearman correlation |
| 0.3033 |
| Spearman r |
| -0.2570 |
| 2-Sided |
| 95 |
| -0.6549 |
| 0.2526 |
| Other |
| Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 60 minutes post Eovist injection. | nonparametric Spearman correlation | 0.2351 | Spearman r | -0.2861 | 2-Sided | 95 | -0.6634 | 0.2071 | Other |
| Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA < or >/= 20ng/ml. | Mann Whitney | 0.111 | Median Difference (actual) | -0.47 | 2-Sided | Other |
| Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA < or >/= 20ng/ml. | Mann Whitney | 0.7738 | Median Difference (actual) | -0.7750 | 2-Sided | Other |