A Phase 2 interventional study of Eovist in Prostate Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-07-08.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Diagnostic
Background:
Objectives:
Eligibility:
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:
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 24 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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.
Drug: Eovist
Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.
Drug: Eovist
0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
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.
Time frame: Baseline and 20 minutes, 40 minutes, and 60 minutes after Eovist injection
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.
Time frame: 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.
Time frame: 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.
Time frame: From date treatment consent signed to date off study, approximately 3 years and 33 days
| Milestone | Participants With Advanced Disease | Participants With Localized Disease |
|---|---|---|
| Started | 12 | 12 |
| Completed | 10 | 11 |
| Not completed | 2 | 1 |
| Withdrew: Patient noncompliance | 2 | 1 |
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.
| contrast enhancement ratio (CER) | Participants With Advanced Disease | Participants With Localized Disease |
|---|---|---|
| Baseline | 2.01 ± 1.16 | 1.857 ± 0.41 |
| 20 minutes after Eovist | 2.52 ± 1.26 | 2.212 ± 0.36 |
| 40 minutes after Eovist | 2.52 ± 1.39 | 2.05 ± 0.34 |
| 60 minutes after Eovist | 2.56 ± 1.45 | 2.06 ± 0.34 |
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.
| Participants | Participants With Advanced Disease | Participants With Localized Disease |
|---|---|---|
| Gleason score <7 | 0 | 1 |
| Gleason score ≥7 | 9 | 9 |
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.
| ng/mL | Participants With Advanced Disease | Participants With Localized Disease |
|---|---|---|
| Baseline Serum Prostate-Specific Antigen (PSA) Levels of Patients Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection | 163.17 ± 208.50 | 11.46 ± 13.15 |
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.
| Participants | Participants With Advanced Disease | Participants With Localized Disease |
|---|---|---|
| Number of Participants With Serious and Non-serious Adverse Events | 1 | 0 |
Collected over From date treatment consent signed to date off study, approximately 3 years and 33 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Advanced Disease | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| Participants With Localized Disease | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Event | Participants With Advanced Disease | Participants With Localized Disease |
|---|---|---|
| NauseaGastrointestinal disorders | 1/12 | 0/12 |
| Age, Categorical(Participants) | Participants With Advanced Disease | Participants With Localized Disease | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 6 | 12 |
| >=65 years | 6 | 6 | 12 |
| Age, Continuous(years) | Participants With Advanced Disease | Participants With Localized Disease | Total |
|---|---|---|---|
| Mean | 65.67 ± 10.59 | 65.17 ± 7.30 | 65.42 ± 8.90 |
| Sex: Female, Male(Participants) | Participants With Advanced Disease | Participants With Localized Disease | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 12 | 12 | 24 |
| Ethnicity (NIH/OMB)(Participants) | Participants With Advanced Disease | Participants With Localized Disease | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 12 | 12 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Participants With Advanced Disease | Participants With Localized Disease | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 9 | 9 | 18 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Participants With Advanced Disease | Participants With Localized Disease | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
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