Cancer of the ProstateEarly Phase 1NCT03960788
Gadoxetate Sodium Enhanced MRI as a Biomarker for Aggressive Prostate Cancer
A Early Phase 1 study testing Gadoxetate Sodium in people with Cancer of the Prostate and Castration-resistant Prostate Cancer, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to test to see if Gadoxetate Sodium is a useful contrast agent for detecting prostate cancer during magnetic resonance imaging (MRI). Gadoxetate Sodium is an FDA approved contrast agent that is currently used to detect liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer of the Prostate, Castration-resistant Prostate Cancer
- What is being tested?
- Gadoxetate Sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 2 Jan 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is greater than or equal to 18 years old.
- Subjects with clinically localized OR advanced prostate cancer with biopsy confirmation and sufficient tissue available (obtained before Gadoxetate Sodium injection) for OATP1B3 expression.
- Subjects must have a prior MRI with gadolinium obtained as part of their standard of care for comparison available. This may have been obtained as part of an image guided biopsy.
- Serum creatinine within 3 weeks prior to Gadoxetate Sodium MRI less than or equal to 1.8mg/dl and estimated glomerular filtration rate (eGFR) must be greater than 60 ml/min/1.73m.
- Patients must have normal liver function as defined below: total bilirubin less than 2 times normal institutional limits or greater than 3.0 mg/dl in patients with Gilbert s syndrome AST(SGOT) and ALT(SGPT) less than or equal to 3 times institutional upper limit of normal
- Ability of subject to sign a written informed consent document.
Who cannot join
- Subjects that have received a prostatectomy
- Subjects with known hypersensitivity and allergy to gadolinium contrast agents
- Subjects with chronic kidney disease or acute kidney injury. Chronic Kidney disease is GFR<30. Acute kidney injury (AKI) is defined as an abrupt or rapid decline in renal filtration function and is screened by excluding patient's that have a GFR <60 within 3 weeks of their scan, as well as screening patients on the day of the scan for kidney disease and contraindications using the standard form based on the Updated ACR Screening Recommendations on Gadolinium Based MR Contrast Agents, Renal Disease Patients. Patients who show signs of renal disease from this form will be excluded from the study.
- Subjects with contraindications to MRI
- Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Benjamin Quast, 513-584-0220, quastbn@ucmail.uc.edu
Sadhna Verma, MD
About this study
Official title: Gadoxetate Sodium Enhanced Magnetic Resonance Imaging (MRI) as a Biomarker for Aggressive Prostate Cancer
The purpose of this research study is to test to see if Gadoxetate Sodium is a useful contrast agent for detecting prostate cancer during magnetic resonance imaging (MRI). Gadoxetate Sodium is an FDA approved contrast agent that is currently used to detect liver cancer. Gadoxetate Sodium shows promise in identifying more aggressive prostate cancers at earlier stages. The study will also test to see if specific genes are expressed in the left over tissue samples from previous prostate fusion biopsy. The investigators hypothesize that Gadoxetate Sodium-enhanced MRI can differentiate aggressive prostate cancer and predict its early recurrence.
Read the detailed description
A substantial body of evidence implicates androgen hormones, such as testosterone, play a key role in aggressive prostate carcinogenesis, and much work has been done to evaluate the relationship between the concentration of testosterone and clinical outcome of patients with prostate cancer. Several uptake transporters localized to the cell membrane have shown to enhance steroid hormone uptake, and these same transporters are also expressed within the prostate where they could increase the capability of neoplastic cells to use testosterone. One group of uptake carriers is the organic anion-transporting polypeptide (OATP) superfamily encoded by SLCO genes. OATPs are localized to normal human hepatocytes. OATP1B3, a member of this family, is also expressed by cancer cells derived from aggressive prostate cancer. Studies have shown that in prostate cancer, testosterone uptake by cells occurs via OATP1B3, and its presence increases from undetectable levels in normal prostatic tissue and benign hyperplasia to marked expression in aggressive prostate cancer.
Current prostate cancer (PCa) diagnosis methods have false positives and are limited in predicting cancer recurrence. Gadoxetate Sodium is a magnetic resonance imaging agent which is FDA-approved gadolinium chelate for detecting hepatocellular carcinoma, as normal hepatocytes express OATP1B3 while most hepatocellular carcinomas do not. Gadoxetate Sodium acts as a substrate for OTAP1B3, therefore, OATP1B3 positive prostate tumors can potentially be visualized on MR imaging. Making this contrast agent useful in the evaluation of OATP1B3 status in patients with aggressive PCa and potentially serve as a prognostic and treatment biomarker.
The investigators hypothesize that Gadoxetate Sodium -enhanced MRI can differentiate aggressive PCa and predict its early recurrence. The investigators aim to enroll 50 patients and sort them into localized or metastatic PCa, based on tumor grade. Subjects that agree to participate will be scheduled for a research pelvic MRI with the Gadoxetate Sodium contrast within 3 weeks of their office visit. The procedure is be conducted as a standard pelvic MRI but instead of gadolinium contrast being administered, Gadoextate Sodium will be dosed at 0.1/mL per kilogram of body weight (as prescribed on the contrast label). Once the subject has undergone the research MRI scan using Gadoxetate Sodium, the MRI and assigned enhancement ratios will be reviewed. Contrast enhancement ratios (CERs) will be calculated to evaluate the difference in the degree of enhancement between the tumors and normal tissue. Subject demographic information, medical history and enhancement ratios will be recorded in the study database.
Previously obtained remnant biopsy samples from enrolled subjects will be used for transcriptome and epigenome profiling using genome-wide and targeted gene approaches.
- Being tested
- Gadoxetate Sodium
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadoxetate SodiumDrug
Gadoxetate Sodium is an FDA approved contrast agent to be used during magnetic resonance imaging.
| Study group | Role | What they receive |
|---|---|---|
| MRI with Gadoxetate Sodium | Experimental | Subjects will receive Gadoxetate Sodium during MRI. Receives: Drug: Gadoxetate Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Gadoxetate Sodium to gadolinium in effectiveness of identification of prostate cancer as measured by contrast enhancement ratios
This single outcome will be measured by comparing the contrast enhancement ratio from pre-study images from participating subjects originally imaged with gadolinium enhanced contrast against contrast enhancement ratios from subjects receiving Gadoxetate Sodium enhanced scans. The measurements taken using the enhancement ratios will be for two areas of interest in the prostate in tumor tissue and these will be collected from pre-study, and post-study images only.
A contrast enhancement ratio is a quantitative measure used to assess the degree of enhancement (brightness) between normal and abnormal tissue in imaging.
Measured: 3 weeks from consent
Secondary outcomes (1)
Comparison of the contrast enhancement ratio of OATP1B3 + and - samples taken from post-Gadoxetate Sodium subjects to determine if Gadoxetate Sodium to determine if it differentiates androgen resistant cancers.
This single outcome will be measured by collecting a tumor tissue biopsy post scan with Gadoxetate Sodium, performing a molecular analysis for the genetic marker OATP1B3 (agent present in resistant cancers) and comparing the contrast enhancement ratio in those samples that have OATP1B3 to those samples without.
A contrast enhancement ratio is a quantitative measure used to assess the degree of enhancement (brightness) between normal and abnormal tissue in imaging.
Measured: 3 weeks from consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start2 Jan 2018
- Primary completion2 Jan 2020 (estimated)
- Study completion2 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the ProstateStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadhna Verma, University of Cincinnati
- Investigators
- Sadhna Verma, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960788
- Sponsor's protocol ID
- EOVIST
- Status last verified
- May 2019
- First submitted
- 23 Apr 2019
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gadoxetate Sodium Enhanced Magnetic Resonance Imaging (MRI) as a Biomarker for Aggressive Prostate Cancer
- ClinicalTrials.gov ID
- NCT03960788
- Acronym / sponsor ID
- EOVIST
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 2 Jan 2020 (estimated)
- Study completion
- 2 Jan 2021 (estimated)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test to see if Gadoxetate Sodium is a useful contrast agent for detecting prostate cancer during magnetic resonance imaging (MRI). Gadoxetate Sodium is an FDA approved contrast agent that is currently used to detect liver cancer. Gadoxetate Sodium shows promise in identifying more aggressive prostate cancers at earlier stages. The study will also test to see if specific genes are expressed in the left over tissue samples from previous prostate fusion biopsy. The investigators hypothesize that Gadoxetate Sodium-enhanced MRI can differentiate aggressive prostate cancer and predict its early recurrence.
Detailed description
A substantial body of evidence implicates androgen hormones, such as testosterone, play a key role in aggressive prostate carcinogenesis, and much work has been done to evaluate the relationship between the concentration of testosterone and clinical outcome of patients with prostate cancer. Several uptake transporters localized to the cell membrane have shown to enhance steroid hormone uptake, and these same transporters are also expressed within the prostate where they could increase the capability of neoplastic cells to use testosterone. One group of uptake carriers is the organic anion-transporting polypeptide (OATP) superfamily encoded by SLCO genes. OATPs are localized to normal human hepatocytes. OATP1B3, a member of this family, is also expressed by cancer cells derived from aggressive prostate cancer. Studies have shown that in prostate cancer, testosterone uptake by cells occurs via OATP1B3, and its presence increases from undetectable levels in normal prostatic tissue and benign hyperplasia to marked expression in aggressive prostate cancer.
Current prostate cancer (PCa) diagnosis methods have false positives and are limited in predicting cancer recurrence. Gadoxetate Sodium is a magnetic resonance imaging agent which is FDA-approved gadolinium chelate for detecting hepatocellular carcinoma, as normal hepatocytes express OATP1B3 while most hepatocellular carcinomas do not. Gadoxetate Sodium acts as a substrate for OTAP1B3, therefore, OATP1B3 positive prostate tumors can potentially be visualized on MR imaging. Making this contrast agent useful in the evaluation of OATP1B3 status in patients with aggressive PCa and potentially serve as a prognostic and treatment biomarker.
The investigators hypothesize that Gadoxetate Sodium -enhanced MRI can differentiate aggressive PCa and predict its early recurrence. The investigators aim to enroll 50 patients and sort them into localized or metastatic PCa, based on tumor grade. Subjects that agree to participate will be scheduled for a research pelvic MRI with the Gadoxetate Sodium contrast within 3 weeks of their office visit. The procedure is be conducted as a standard pelvic MRI but instead of gadolinium contrast being administered, Gadoextate Sodium will be dosed at 0.1/mL per kilogram of body weight (as prescribed on the contrast label). Once the subject has undergone the research MRI scan using Gadoxetate Sodium, the MRI and assigned enhancement ratios will be reviewed. Contrast enhancement ratios (CERs) will be calculated to evaluate the difference in the degree of enhancement between the tumors and normal tissue. Subject demographic information, medical history and enhancement ratios will be recorded in the study database.
Previously obtained remnant biopsy samples from enrolled subjects will be used for transcriptome and epigenome profiling using genome-wide and targeted gene approaches.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI with Gadoxetate Sodium | Experimental | Drug: Gadoxetate SodiumSubjects will receive Gadoxetate Sodium during MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is greater than or equal to 18 years old.
- Subjects with clinically localized OR advanced prostate cancer with biopsy confirmation and sufficient tissue available (obtained before Gadoxetate Sodium injection) for OATP1B3 expression.
- Subjects must have a prior MRI with gadolinium obtained as part of their standard of care for comparison available. This may have been obtained as part of an image guided biopsy.
- Serum creatinine within 3 weeks prior to Gadoxetate Sodium MRI less than or equal to 1.8mg/dl and estimated glomerular filtration rate (eGFR) must be greater than 60 ml/min/1.73m.
- Patients must have normal liver function as defined below: total bilirubin less than 2 times normal institutional limits or greater than 3.0 mg/dl in patients with Gilbert s syndrome AST(SGOT) and ALT(SGPT) less than or equal to 3 times institutional upper limit of normal
Key exclusion criteria (5 listed)
- Subjects that have received a prostatectomy
- Subjects with known hypersensitivity and allergy to gadolinium contrast agents
- Subjects with chronic kidney disease or acute kidney injury. Chronic Kidney disease is GFR<30. Acute kidney injury (AKI) is defined as an abrupt or rapid decline in renal filtration function and is screened by excluding patient's that have a GFR <60 within 3 weeks of their scan, as well as screening patients on the day of the scan for kidney disease and contraindications using the standard form based on the Updated ACR Screening Recommendations on Gadolinium Based MR Contrast Agents, Renal Disease Patients. Patients who show signs of renal disease from this form will be excluded from the study.
- Subjects with contraindications to MRI
- Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadoxetate SodiumGadoxetate Sodium is an FDA approved contrast agent to be used during magnetic resonance imaging. | Drug | MRI with Gadoxetate Sodium |
Primary outcome
Comparison of Gadoxetate Sodium to gadolinium in effectiveness of identification of prostate cancer as measured by contrast enhancement ratios
Time frame: 3 weeks from consent
This single outcome will be measured by comparing the contrast enhancement ratio from pre-study images from participating subjects originally imaged with gadolinium enhanced contrast against contrast enhancement ratios from subjects receiving Gadoxetate Sodium enhanced scans. The measurements taken using the enhancement ratios will be for two areas of interest in the prostate in tumor tissue and these will be collected from pre-study, and post-study images only. A contrast enhancement ratio is a quantitative measure used to assess the degree of enhancement (brightness) between normal and abnormal tissue in imaging.
1 secondary outcome
Comparison of the contrast enhancement ratio of OATP1B3 + and - samples taken from post-Gadoxetate Sodium subjects to determine if Gadoxetate Sodium to determine if it differentiates androgen resistant cancers.
Time frame: 3 weeks from consent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadhna Verma, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gadoxetate Sodium in people with Cancer of the Prostate and Castration-resistant Prostate Cancer, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicky Kurtzweil (5135840904, kurtzwny@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Gadoxetate Sodium to gadolinium in effectiveness of identification of prostate cancer as measured by contrast enhancement ratios (time frame: 3 weeks from consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.