Prostate AdenocarcinomaPhase 3NCT03404648
Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI
A Phase 3 study testing C-11 choline PET tracer, Gadobutrol and PET/MR scanner in people with Prostate Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- C-11 choline PET tracer, Gadobutrol and PET/MR scanner
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 23 Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Staging of Untreated Patients With Very High-risk and High-risk Prostate Carcinoma Utilizing Hybrid C11-choline PET/MR and Pelvic Multiparametric MRI for Personalized Precise Treatment: a Pilot Study
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.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- C-11 choline PET tracer, Gadobutrol, PET/MR scanner
- Keywords
- high risk, prostate cancer, C11-choline, PET/MR, mpMRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-11 choline PET tracerDrug
Also called Choline C-11 Injection
C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.
GadobutrolDrug
Also called Gadavist
Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.
PET/MR scannerDevice
Also called GE SIGNA 3T PET/MR scanner
C11-PET/MR and pelvic mpMRI scan for prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: C-11 choline PET tracer; Drug: Gadobutrol; Device: PET/MR scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Number of Lesions Showing C11-Choline Uptake
Measured by the mean number of lesions to show C11-Choline uptake.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Nov 2017
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Yang, M.D., Mayo Clinic
- Investigators
- Ming Yang, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404648
- Sponsor's protocol ID
- 16-007897
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2018
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staging of Untreated Patients With Very High-risk and High-risk Prostate Carcinoma Utilizing Hybrid C11-choline PET/MR and Pelvic Multiparametric MRI for Personalized Precise Treatment: a Pilot Study
- ClinicalTrials.gov ID
- NCT03404648
- Acronym / sponsor ID
- 16-007897
- Conditions
- Prostate Adenocarcinoma
- Keywords
- high risk, prostate cancer, C11-choline, PET/MR, mpMRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Posted 8 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Risk Prostate Cancer Patients | Experimental | Drug: C-11 choline PET tracer, Drug: Gadobutrol, Device: PET/MR scannerSubjects 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-11 choline PET tracerAlso: Choline C-11 InjectionC-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table. | Drug | High Risk Prostate Cancer Patients |
| GadobutrolAlso: GadavistSingle dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously. | Drug | High Risk Prostate Cancer Patients |
| PET/MR scannerAlso: GE SIGNA 3T PET/MR scannerC11-PET/MR and pelvic mpMRI scan for prostate cancer. | Device | High Risk Prostate Cancer Patients |
Primary outcome
Uptake Value of C11-choline
Time frame: Baseline
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.
Number of Lesions Showing C11-Choline Uptake
Time frame: Baseline
Measured by the mean number of lesions to show C11-Choline uptake.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Yang principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing C-11 choline PET tracer, Gadobutrol and PET/MR scanner in people with Prostate Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake Value of C11-choline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.