NCT01867424

Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer

Completed Phase 2 Results posted Last updated 8 July 2020

What this trial tests

Phase 2 trial testing Eovist in Prostate Cancer in 24 participants. Completed in 8 December 2016.

Timeline

14 May 2013

Primary endpoint
30 May 2016

8 December 2016

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	24
Start date	14 May 2013
Primary completion	30 May 2016
Estimated completion	8 December 2016
Sites	1 location across United States

Drugs / interventions tested

• Eovist — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 99, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Uptake and Retention of Eovist in Prostate Cancers Primary · Baseline and 20 minutes, 40 minutes, and 60 minutes after Eovist injection

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

Group	Value	95% CI
Participants With Advanced Disease	2.01	± 1.16
Participants With Localized Disease	1.857	± 0.41

20 minutes after Eovist

Group	Value	95% CI
Participants With Advanced Disease	2.52	± 1.26
Participants With Localized Disease	2.212	± 0.36

40 minutes after Eovist

Group	Value	95% CI
Participants With Advanced Disease	2.52	± 1.39
Participants With Localized Disease	2.05	± 0.34

60 minutes after Eovist

Group	Value	95% CI
Participants With Advanced Disease	2.56	± 1.45
Participants With Localized Disease	2.06	± 0.34

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

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.

Gleason score <7

Group	Value	95% CI
Participants With Advanced Disease	0
Participants With Localized Disease	1

Gleason score ≥7

Group	Value	95% CI
Participants With Advanced Disease	9
Participants With Localized Disease	9

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

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.

Group	Value	95% CI
Participants With Advanced Disease	163.17	± 208.50
Participants With Localized Disease	11.46	± 13.15

Number of Participants With Serious and Non-serious Adverse Events Secondary · From date treatment consent signed to date off study, approximately 3 years and 33 days

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

Group	Value	95% CI
Participants With Advanced Disease	1
Participants With Localized Disease	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From date treatment consent signed to date off study, approximately 3 years and 33 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With Advanced Disease

Serious: 0/12 (0%)

Deaths: 0/12

Participants With Localized Disease

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (1 terms — click to expand)

Reaction	System	Participants With Advanced…	Participants With Localize…
Nausea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT01867424 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pilot study of gadoxetate disodium-enhanced mri for localized and metastatic prostate cancers.
   Lochrin SE, Turkbey B, Gasmi B, Schmidt K, et al · · 2021 · cited 2× · PMID 33707581 · DOI 10.1038/s41598-021-84960-w