Prostate AdenocarcinomaBoneMetPETCTNCT03496844

Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma

A study testing F-18 fluciclovine-PET/CT scan in people with Prostate Adenocarcinoma, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy. 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?: F-18 fluciclovine-PET/CT scan
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 15 Apr 2018to 27 Apr 2021
Phase: Interventional
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

Male
Be ≥ 18 years of age
Diagnosed with prostate cancer
Be willing and able to provide informed consent
Be informed of the investigational nature of this study

Who cannot join

Having a history of severe claustrophobia
Weight exceeding 400lbs

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arizona
Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: A Pilot Study of F-18 Fluciclovine-PET/CT as A Diagnostic Tool for Bone Metastases in Patients With Hormonal Sensitive and Resistant Prostate Adenocarcinoma

Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.

Conditions: Prostate Adenocarcinoma
Being tested: F-18 fluciclovine-PET/CT scan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

F-18 fluciclovine-PET/CT scanDiagnostic test
Also called Axumin-PET scan
PET/CT imaging with F-18 fluciclovine

Study groups in NCT03496844
Study group	Role	What they receive
Routine F-18 fluciclovine-PET/CT scan	No intervention	This arm will consist of prostate cancer patients who have had an F-18 fluciclovine-PET/CT scan for routine standard of care for biochemical recurrence. These patients would be asked to participate in the study only if there is a need for a standard of care bone biopsy.
Research F-18 fluciclovine-PET/CT scan	Active comparator	This arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. For example, a patient with known lymph node recurrence of prostate cancer and suspicious finding on a bone scan would be asked to participate in the study and get a F-18 fluciclovine-PET/CT scan prior to the standard of care bone biopsy. Receives: Diagnostic Test: F-18 fluciclovine-PET/CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy
True positive and false positive rates of positive findings in the skeleton on F-18 fluciclovine-PET/CT scan compared to gold standard pathology from bone biopsy
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 201827 Apr 2021

First posted12 Apr 2018
Study start15 Apr 2018
Primary completion27 Apr 2021
Study completion27 Apr 2021

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 University of ArizonaThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03496844
Sponsor's protocol ID: 1803340164
Acronym: BoneMetPETCT
Status last verified: Aug 2022
First submitted: 5 Apr 2018
Last updated: 16 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: We do not plan to make individual participant data available to other researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
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Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
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Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

All Prostate Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of F-18 Fluciclovine-PET/CT as A Diagnostic Tool for Bone Metastases in Patients With Hormonal Sensitive and Resistant Prostate Adenocarcinoma
ClinicalTrials.gov ID: NCT03496844
Acronym / sponsor ID: BoneMetPETCT / 1803340164
Conditions: Prostate Adenocarcinoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of ArizonaUniversity, hospital or other
Collaborators: Blue Earth Diagnostics, Banner University Medical Center
Study start: 15 Apr 2018 (actual)
Primary completion: 27 Apr 2021 (actual)
Study completion: 27 Apr 2021 (actual)
First posted: 12 Apr 2018 (actual)
Results: Posted 9 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Routine F-18 fluciclovine-PET/CT scan	No intervention	–This arm will consist of prostate cancer patients who have had an F-18 fluciclovine-PET/CT scan for routine standard of care for biochemical recurrence. These patients would be asked to participate in the study only if there is a need for a standard of care bone biopsy.
Research F-18 fluciclovine-PET/CT scan	Active comparator	Diagnostic Test: F-18 fluciclovine-PET/CT scanThis arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. For example, a patient with known lymph node recurrence of prostate cancer and suspicious finding on a bone scan would be asked to participate in the study and get a F-18 fluciclovine-PET/CT scan prior to the standard of care bone biopsy.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male
Be ≥ 18 years of age
Diagnosed with prostate cancer
Be willing and able to provide informed consent
Be informed of the investigational nature of this study

Key exclusion criteria (2 listed)

Having a history of severe claustrophobia
Weight exceeding 400lbs

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
F-18 fluciclovine-PET/CT scanAlso: Axumin-PET scanPET/CT imaging with F-18 fluciclovine	Diagnostic test	Research F-18 fluciclovine-PET/CT scan

Primary outcome

True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy
Time frame: 1 year
True positive and false positive rates of positive findings in the skeleton on F-18 fluciclovine-PET/CT scan compared to gold standard pathology from bone biopsy

Results and safety

Results posted to the registry on 9 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Research F-18 Fluciclovine-PET/CT Scan	15	15

Primary outcome: True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy

Time frame: 1 year. Number. Unit: participants

Measure	Research F-18 Fluciclovine-PET/CT Scan n = 13
Total participants with bone biopsy	13
Number of Participants with Positive Bone Biopsy on Pathology	7
Number of Participants with Negative Bone Biopsy on Pathology	6

Population analysed: Subjects who underwent bone biopsy

Adverse events

Time frame: Adverse events were collected for 1 week after the PET/CT scan was completed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Research F-18 Fluciclovine-PET/CT Scan	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Limitations and caveats (from the sponsor): Due to total lack of recruitment to cohort 1 consisting of Prostate Cancer patients who have had an F-18 fluciclovine-PET/CT scan for routine standard of care for biochemical recurrence, cohort 1 was dropped from the study. All consented subjects were in cohort 2. Data collected for subjects who underwent bone biopsy; 2 subjects were found to have non-bone sites more clinically appropriate to biopsy which resulted in less bone biopsy data to analyze.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. We do not plan to make individual participant data available to other researchers.

Related trials for Prostate Adenocarcinoma

RecruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
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Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

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.

Phillip H Kuo, MD, PhD principal investigator

University of Arizona

Hani Babiker, MD principal investigator

University of Arizona

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing F-18 fluciclovine-PET/CT scan in people with Prostate Adenocarcinoma, run by University of Arizona 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 5 inclusion and 2 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 16 Aug 2022. 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?

Yes. Results are posted in the registry (first posted 9 Aug 2022). 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?

True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03496844.

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 16 Aug 2022.