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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI with Gadoxetate Sodium | Experimental | Subjects will receive Gadoxetate Sodium during MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadoxetate Sodium | Drug | Gadoxetate Sodium is an FDA approved contrast agent to be used during magnetic resonance imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 weeks from consent |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Only Males may apply due to condition under study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicky Kurtzweil | Contact | 5135840904 | kurtzwny@ucmail.uc.edu | |
| Melanie Gruen | Contact | 15135848131 | gruenml@ucmail.uc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sadhna Verma, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45267 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 16, 2025 | |
| Reset | Jan 7, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 16, 2025 | Jan 7, 2026 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 3 weeks from consent |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |