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CompletedNCT03404648Updated Feb 8, 2021Results posted

Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI

A Phase 3 interventional study of C-11 choline PET tracer and Gadobutrol in Prostate Adenocarcinoma, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-08.

Sponsored by Mayo Clinic · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the detailed description

High risk prostate cancer patients will undergo C11-Choline PET/MR whole body fusion scan and pelvic mpMRI for accurate staging. The PET/MR imaging findings, including the primary lesion with the prostate bed and pelvic lymph nodes, will be correlated with the histopathologic result. Researchers aim to provide accurate one-stop shopping opportunity in diagnosis and staging of high risk prostate cancer using the C11-choline PET/MR scan.

02

Conditions studied

  • Prostate Adenocarcinoma

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Keywords

  • high risk
  • prostate cancer
  • C11-choline
  • PET/MR
  • mpMRI
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.

Exclusion criteria

Exclusion Criteria:

  1. Patients who already received primary treatment or neo-adjuvant therapy.
  2. 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.
  3. Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm, involuntary movement [e.g., tremor, dystonia]).
  4. Patients have total hip arthroplasty (THA), which can cause substantial susceptibility artifact and degrade image quality of mpMRI.
  5. Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit.
  6. 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.
04

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    High Risk Prostate Cancer Patients

    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 tracer · Drug: Gadobutrol · Device: PET/MR scanner

Interventions

  • DrugC-11 choline PET tracer

    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

  • DrugGadobutrol

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

    Also known as: Gadavist

  • DevicePET/MR scanner

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

    Also known as: GE SIGNA 3T PET/MR scanner

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. Number of Lesions Showing C11-Choline Uptake

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

    Time frame: Baseline

06

Results

Posted Feb 8, 2021

Participant flow

Participant flow — Overall Study
MilestoneHigh Risk Prostate Cancer Patients
Started19
Completed19
Not completed0

Outcome measures

PrimaryUptake 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.

Time frame:
Baseline
Reported as:
Mean · Ratio
Uptake Value of C11-choline
RatioHigh Risk Prostate Cancer Patients
Uptake Value of C11-choline6.2 ± 1.8
PrimaryNumber of Lesions Showing C11-Choline Uptake

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

Time frame:
Baseline
Reported as:
Mean · Lesions
Number of Lesions Showing C11-Choline Uptake
LesionsHigh Risk Prostate Cancer Patients
Number of Lesions Showing C11-Choline Uptake1.2 ± 0.4

Adverse events

Collected over Adverse events were collected from baseline to end of study participation for a total of approximately 2 days on all participants.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
High Risk Prostate Cancer Patients0/19 (0%)0/19 (0%)0/19 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)High Risk Prostate Cancer Patients
Mean63.9 ± 6.0
Sex: Female, Male
Sex: Female, Male(Participants)High Risk Prostate Cancer Patients
Female0
Male19
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)High Risk Prostate Cancer Patients
Region of Enrollment
Region of Enrollment(participants)High Risk Prostate Cancer Patients
United States19
07

Study locations

1 site
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 3, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03404648
Lead sponsor
Mayo Clinic
Responsible party
Ming Yang, M.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 19, 2018
Start date
Nov 1, 2017
Primary completion
Jan 23, 2020
Completion
Jan 23, 2020
Results posted
Feb 8, 2021
Last update
Feb 8, 2021

Study contacts

Ming Yang
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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