Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer

NCT01867424 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 13014513-C-0145
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Participants will be screened with a physical exam and medical history. Blood samples will be collected.
• Participants will have a magnetic resonance imaging (MRI) scan of the lower torso. They will receive gadoxetate during the MRI scan.
• Participants who have surgery will have a sample of their tumor cells collected. Those who have a biopsy will provide cells from this biopsy for study.
• Treatment will not be provided as part of this study.

Conditions

Prostate Cancer

Keywords

Testosterone Membrane Transporter; OATP1B3; Castration Resistant Prostate Cancer; Prostatectomy; Gadolinium-Based Contrast Agent

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Number of Participants Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection With Respect to Gleason Score

  At baseline

• Baseline Serum Prostate-Specific Antigen (PSA) Levels of Patients Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection

  Baseline

• Number of Participants With Serious and Non-serious Adverse Events

  From date treatment consent signed to date off study, approximately 3 years and 33 days

Study Arms (2)

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.

Drug: Eovist

Participants with Localized Disease

ACTIVE COMPARATOR

Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.

Drug: Eovist

Interventions

Eovist DRUG

0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Participants with Advanced Disease; Participants with Localized Disease

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is greater than or equal to 18 years old.
• 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.
• 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.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
• 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).
• 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 Gilberts syndrome
• Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times institutional upper limit of normal
• Ability of subject to sign a written informed consent document

You may not qualify if:

• Subjects with known hypersensitivity and allergy to gadolinium contrast agents
• Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results
• Subjects with severe claustrophobia unresponsive to oral anxiolytics
• Subjects with contraindications to magnetic resonance imaging (MRI)
• Subjects weighing greater than 136 kg (weight limit for scanner table)
• Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI
• Subjects with other medical conditions deemed by the principle investigator (or associates) to make the subject ineligible for protocol procedures
• Subjects who will have a delay in clinically indicated radiation therapy due to the interval between Eovist MRI imaging and biopsy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 19404564 BACKGROUND

• 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.

  PMID: 20610543 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.

  PMID: 18519758 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gadolinium ethoxybenzyl DTPA

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Ismail Baris Turkbey
• Organization: National Cancer Institute

turkbey@nih.gov

301-443-2315

Study Officials

• Ismail B Turkbey, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 4, 2013
• Study Start: May 14, 2013
• Primary Completion: May 30, 2016
• Study Completion: December 8, 2016
• Last Updated: July 8, 2020
• Results First Posted: March 20, 2018

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)