Prostate CancerNCT04009083
Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)
A study testing Fluciclovine PET scan added to MRI in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a prospective outcomes study assessing quality of life and oncological control at pre-defined time points following FOCAL CRYO-ABLATION (FCA). The investigator's standard of care is to perform an Magentic Resonance Imaging (MRI) and prostate biopsy two years following FCA. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Fluciclovine PET scan added to MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2019to 7 Jan 2021
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FCA at NYU Langone Health performed at least two years prior to study enrollment by Drs. Lepor or Wysock.
- No prostate cancer specific treatment following FCA
- Consented to undergo reflex MRI and prostate biopsy two years following FCA.
Who cannot join
- Any contraindication to prostate biopsy
- Prior allergic reaction to 18F-Fluciclovine
- Patient refuses MRI and prostate biopsy two years following FCA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CLINICAL UTILITY OF AXUMIN PET/MRI IMAGING TWO YEARS FOLLOWING FOCAL CRYO-ABLATION (FCA) OF PROSTATE CANCER
This is a prospective outcomes study assessing quality of life and oncological control at pre-defined time points following FOCAL CRYO-ABLATION (FCA). The investigator's standard of care is to perform an Magentic Resonance Imaging (MRI) and prostate biopsy two years following FCA. The prostate biopsy assesses both the presence of in field and out of field disease. The role of Axumin PET/MRI for detecting disease following FCA has not been previously examined.
Read the detailed description
The primary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of in field recurrence of significant prostate cancer defined as any Gleason pattern 4 disease.
The secondary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of out of field recurrence of significant prostate cancer .
- Conditions
- Prostate Cancer
- Being tested
- Standard of Care MRI, Fluciclovine PET scan added to MRI
- Keywords
- 18F-Fluciclovine PET imaging, Focal Cryo Ablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care MRIDevice
Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies
Fluciclovine PET scan added to MRIOther
18F-Fluciclovine (Axumin) is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Not described Receives: Device: Standard of Care MRI |
| 18F-Fluciclovine PET Scan | Experimental | Not described Receives: Other: Fluciclovine PET scan added to MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start19 Jun 2019
- Primary completion7 Jan 2021
- Study completion7 Jan 2021
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 NYU Langone HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herbert Lepor, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009083
- Sponsor's protocol ID
- 19-00123
- Status last verified
- Mar 2021
- First submitted
- 2 Jul 2019
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL UTILITY OF AXUMIN PET/MRI IMAGING TWO YEARS FOLLOWING FOCAL CRYO-ABLATION (FCA) OF PROSTATE CANCER
- ClinicalTrials.gov ID
- NCT04009083
- Acronym / sponsor ID
- 19-00123
- Conditions
- Prostate Cancer
- Keywords
- 18F-Fluciclovine PET imaging, Focal Cryo Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 5 Jul 2019 (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.
This is a prospective outcomes study assessing quality of life and oncological control at pre-defined time points following FOCAL CRYO-ABLATION (FCA). The investigator's standard of care is to perform an Magentic Resonance Imaging (MRI) and prostate biopsy two years following FCA. The prostate biopsy assesses both the presence of in field and out of field disease. The role of Axumin PET/MRI for detecting disease following FCA has not been previously examined.
Detailed description
The primary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of in field recurrence of significant prostate cancer defined as any Gleason pattern 4 disease.
The secondary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of out of field recurrence of significant prostate cancer .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Device: Standard of Care MRI |
| 18F-Fluciclovine PET Scan | Experimental | Other: Fluciclovine PET scan added to MRI |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- FCA at NYU Langone Health performed at least two years prior to study enrollment by Drs. Lepor or Wysock.
- No prostate cancer specific treatment following FCA
- Consented to undergo reflex MRI and prostate biopsy two years following FCA.
Key exclusion criteria (3 listed)
- Any contraindication to prostate biopsy
- Prior allergic reaction to 18F-Fluciclovine
- Patient refuses MRI and prostate biopsy two years following FCA.
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 |
|---|---|---|
| Standard of Care MRIProstate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies | Device | Standard of Care |
| Fluciclovine PET scan added to MRI18F-Fluciclovine (Axumin) is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment | Other | 18F-Fluciclovine PET Scan |
Primary outcome
Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Herbert Lepor, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluciclovine PET scan added to MRI in people with Prostate Cancer, run by NYU Langone Health 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 3 inclusion and 3 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 30 Mar 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin) (time frame: 1 Day). 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 30 Mar 2021.