Prostate CancerPhase 1/2NCT02142608

A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer

A Phase 1/2 study testing BR55 in people with Prostate Cancer, run by Bracco Diagnostics, Inc at 2 sites in 2 countries.

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

Pilot study to evaluate the ability of BR55 to identify prostate cancer lesions with Gleason Score ≥7 by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology results Read more about this study

Who is it for?: Ages 50 to 70 years, men only
Conditions the study is for: Prostate Cancer
What is being tested?: BR55
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 2 sitesin 2 countries
Study dates: Aug 2014to Jan 2016
Phase: Phase 1/2
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 50 to 70 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male, age between 50-70 years old
Increased Prostate-Specific Antigen (PSA) level >4 ng/mL
Known prostate cancer
Scheduled for prostatectomy not earlier than 3 days and not later than 30 days following BR55 administration (with the exception of training cases where this requirement is not applicable)
Provided written informed consent and willing to comply with protocol requirements

Who cannot join

Documented acute prostatitis or urinary tract infections
Known to suffer from stable angina pectoris and/or proven coronary disease, or have symptoms suspicious of coronary disease
History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to left shunts
Severe cardiac rhythm disorders within the last 7 days
Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
Received a prostate biopsy procedure within 30 days before admission into the study
Determined by investigator to be clinically unsuitable for the study
Participated in a concurrent clinical trial or has participated in another clinical trial with an investigational compound within the past 30 days

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Translational Molecular Imaging Lab
Stanford, California, 94305

Other trials in United States

France1 site

Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte
Bordeaux

Other trials in France

About this study

Official title: A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2

Read the detailed description

This multi-centre, open label, prospective, pilot study was designed to assess the ability of BR55 to detect VEGFR2 in human prostate cancer by Ultrasound Molecular Imaging (USMI). The binding of BR55 to VEGFR2 (focal enhancement still visible after significant decrease in signal from circulating microbubbles seen) was assessed at USMI and VEGFR2 expression was to be confirmed by immunohistochemistry (IHC) analysis including VEGFR2 and CD31 staining.

Conditions: Prostate Cancer
Being tested: BR55
Keywords: Prostate cancer, Ultrasound Imaging
Medical subject headings: Prostatic Neoplasms

What participants receive

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

BR55Drug
Ultrasound contrast agent

Study groups in NCT02142608
Study group	Role	What they receive
BR55	Experimental	All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg... Receives: Drug: BR55

What is being measured

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

Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging
To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard
Measured: Within 30 minutes after administration of BR55

Secondary outcomes (1)

Number of Participants With Adverse Events
To obtain safety data in subjects administered BR55
Measured: 24 hours post-dose

Timeline

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

Aug 2014Jan 2016

First posted20 May 2014 (estimated)
Study startAug 2014
Primary completionJul 2015
Study completionJan 2016

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 CancerStudies of the same condition, open and under way.
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 1/2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02142608
Sponsor's protocol ID: BR55-105
Status last verified: Mar 2021
First submitted: 16 May 2014
Last updated: 29 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2
ClinicalTrials.gov ID: NCT02142608
Acronym / sponsor ID: BR55-105
Conditions: Prostate Cancer
Keywords: Prostate cancer, Ultrasound Imaging
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Jul 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 20 May 2014 (estimated)
Results: Posted 27 Aug 2020

Clinical summary

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

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BR55	Experimental	Drug: BR55All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...

Who may qualify

Ages: 50 to 70 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male, age between 50-70 years old
Increased Prostate-Specific Antigen (PSA) level >4 ng/mL
Known prostate cancer
Scheduled for prostatectomy not earlier than 3 days and not later than 30 days following BR55 administration (with the exception of training cases where this requirement is not applicable)
Provided written informed consent and willing to comply with protocol requirements

Key exclusion criteria (8 listed)

Documented acute prostatitis or urinary tract infections
Known to suffer from stable angina pectoris and/or proven coronary disease, or have symptoms suspicious of coronary disease
History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to left shunts
Severe cardiac rhythm disorders within the last 7 days
Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome

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
BR55Ultrasound contrast agent	Drug	BR55

Primary outcome

Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging
Time frame: Within 30 minutes after administration of BR55
To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard

1 secondary outcome

Number of Participants With Adverse Events
Time frame: 24 hours post-dose

Results and safety

Results posted to the registry on 27 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BR55	18	18

Primary outcome: Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging

Time frame: Within 30 minutes after administration of BR55. Number. Unit: number of lesions

Measure	BR55 n = 13
Gleason score ≥7	17
With binding	8

Population analysed: BR55 binding level versus Gleason score in malignant lesions from off-site histopathology

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All adverse events that occurred from the time the patient signed the Informed Consent Form until 24 hours after the last administration of BR55 were recorded.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BR55	0 of 18 (0%)	1 of 18 (5.6%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
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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
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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.

Maria Luigia Storto, M.D. study director

Bracco Diagnostics, Inc

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BR55 in people with Prostate Cancer, run by Bracco Diagnostics, Inc at 2 sites in 2 countries.

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 8 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 29 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 2 sites in United States, France. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 27 Aug 2020). 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?

Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging (time frame: Within 30 minutes after administration of BR55). 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 NCT02142608.

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 29 Mar 2021.