Prostate CancerNCT05035732
A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
A study testing 18F-fluciclovine in people with Prostate Cancer and Prostate Nodule, run by M.D. Anderson Cancer Center.
Trial summary
To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Prostate Nodule
- What is being tested?
- 18F-fluciclovine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2021to 17 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients who are 18 years and older
- Histologically or cytologically proven prostate carcinoma s/p definitive radiation
- Patients suspected to have BCR based on phoenix criteria (prostate specific antigen value (PSA) of 2 ng/mL above the PSA nadir)
- Ability to understand and willingness to sign informed consent
Who cannot join
- Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
- Patients with contraindication to undergo MRI
- Patients with prior allergy to MRI contrast agent.
- Extreme Claustrophobia
About this study
To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner.
Read the detailed description
Primary Objective:
--To compare the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI and to determine whether 18F- Fluciclovine pelvic PET/MRI is more accurate than a pelvic mpMRI in detecting pelvic RRPC in men with biochemical recurrence with histopathology as reference standard.
Secondary Objective:
--To study inter-reader reliability of 18F- Fluciclovine pelvic PET/MRI and pelvic mpMRI among the readers.
Exploratory Objective:
--To study correlation between SUVmax and ADCmean in the pelvic RRPC.
- Conditions
- Prostate Cancer, Prostate Nodule
- Being tested
- 18F-fluciclovine
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluciclovineRadiation
IV
| Study group | Role | What they receive |
|---|---|---|
| 18F-ACBC | Experimental | Not described Receives: Radiation: 18F-fluciclovine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start25 Mar 2021
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Why it stopped: 0 participant accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devaki S Surasi, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035732
- Sponsor's protocol ID
- 2021-0146
- Other IDs
- NCI-2021-09407
- Status last verified
- Jan 2024
- First submitted
- 24 Aug 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
- ClinicalTrials.gov ID
- NCT05035732
- Acronym / sponsor ID
- 2021-0146
- Conditions
- Prostate Cancer, Prostate Nodule
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 0 participant accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner.
Detailed description
Primary Objective:
--To compare the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI and to determine whether 18F- Fluciclovine pelvic PET/MRI is more accurate than a pelvic mpMRI in detecting pelvic RRPC in men with biochemical recurrence with histopathology as reference standard.
Secondary Objective:
--To study inter-reader reliability of 18F- Fluciclovine pelvic PET/MRI and pelvic mpMRI among the readers.
Exploratory Objective:
--To study correlation between SUVmax and ADCmean in the pelvic RRPC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-ACBC | Experimental | Radiation: 18F-fluciclovine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients who are 18 years and older
- Histologically or cytologically proven prostate carcinoma s/p definitive radiation
- Patients suspected to have BCR based on phoenix criteria (prostate specific antigen value (PSA) of 2 ng/mL above the PSA nadir)
- Ability to understand and willingness to sign informed consent
Key exclusion criteria (4 listed)
- Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
- Patients with contraindication to undergo MRI
- Patients with prior allergy to MRI contrast agent.
- Extreme Claustrophobia
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 |
|---|---|---|
| 18F-fluciclovineIV | Radiation | 18F-ACBC |
Primary outcome
To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI
Time frame: through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- M D Anderson Cancer CenterLink 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.
Devaki S Surasi principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing 18F-fluciclovine in people with Prostate Cancer and Prostate Nodule, run by M.D. Anderson Cancer Center.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI (time frame: through study completion, an average of 1 year). 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 18 Jan 2024.