NCT03404648

Brief Summary

The purpose of this study is to find out if a PET/MR scan in combination with standard MRI and CT scans can improve the early detection and treatment of patients with prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 8, 2021

Completed
Last Updated

February 8, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

January 12, 2018

Results QC Date

January 19, 2021

Last Update Submit

January 19, 2021

Conditions

Prostate Adenocarcinoma

Keywords

high riskprostate cancerC11-cholinePET/MRmpMRI

Outcome Measures

Primary Outcomes (2)

  • Uptake Value of C11-choline

    Measured by maximum standardized uptake value (SUVmax) of indexed lesions. SUV is calculated as ratio of concentration of tissue reactivity divided by dose at time of injection divided by body weight.

    Baseline

  • Number of Lesions Showing C11-Choline Uptake

    Measured by the mean number of lesions to show C11-Choline uptake.

    Baseline

Study Arms (1)

High Risk Prostate Cancer Patients

EXPERIMENTAL

Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).

Drug: C-11 choline PET tracerDrug: GadobutrolDevice: PET/MR scanner

Interventions

C-11 choline PET tracerDRUG

C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.

Also known as: Choline C-11 Injection
High Risk Prostate Cancer Patients
GadobutrolDRUG

Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.

Also known as: Gadavist
High Risk Prostate Cancer Patients
PET/MR scannerDEVICE

C11-PET/MR and pelvic mpMRI scan for prostate cancer.

Also known as: GE SIGNA 3T PET/MR scanner
High Risk Prostate Cancer Patients

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Untreated patients with high-risk and very high-risk prostate cancer, who require clinical pelvic mpMRI, CT, and bone scan as standard clinical care for diagnosis and management of prostate cancer.

You may not qualify if:

  • Patients who already received primary treatment or neo-adjuvant therapy.
  • Patients who refuse undergoing routine clinical imaging (i.e., pelvic mpMRI, CT, bone scan) for staging. Reimbursement of pelvic mpMRI in this study is denied. CT and bone scan may be done elsewhere outside of Mayo Clinic but should be of diagnostic quality. Research C-11 choline PET/MR will not substitute pelvic mpMRI, CT, or bone scan in this study.
  • Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm, involuntary movement \[e.g., tremor, dystonia\]).
  • Patients have total hip arthroplasty (THA), which can cause substantial susceptibility artifact and degrade image quality of mpMRI.
  • Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit.
  • Patients have contraindication to gadolinium based MR contrast agents (e.g., renal failure, severe reaction to gadolinium based MR contrast agents). Epidermal growth factor receptor (eGFR) should be above 30 within 30 days the time of mpMRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gadobutrol

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Dr. Ming Yang
Organization
Mayo Clinic
Yang.Ming@mayo.edu
480-342-0988

Study Officials

  • Ming Yang

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 19, 2018

Study Start

November 1, 2017

Primary Completion

January 23, 2020

Study Completion

January 23, 2020

Last Updated

February 8, 2021

Results First Posted

February 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)