Prostate CancerNCT02524860
Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device
A study testing Focal-Fusion Bx in people with Prostate Cancer, run by Focal Healthcare Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting clinically significant prostate cancer in a standard clinical environment. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal-Fusion Bx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2017
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male subjects up to 80 years of age
- Candidates for fusion biopsy
- Elevated PSA levels
- MP-MRI with lesions having a Prostate Imaging Reporting and Data System (PI-RADS) score greater than or equal to 3 (determined by a trained radiologist)
- Subject is willing and able to read, understand and sign the Informed Consent Form document
Who cannot join
- Previous treatment for prostate cancer
- Any contraindication to a standard TRUS prostate biopsy procedure
- Refusal to sign the Informed Consent document
Trial locations and contacts
1 site in 1 country.
United States1 site
Urology Treatment Center (division of 21st Century Oncology, Inc.)
Sarasota, Florida, 34239
About this study
Official title: Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device in Patients With an Elevated PSA and a Positive Multiparametric MRI
The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting clinically significant prostate cancer in a standard clinical environment.
Read the detailed description
The objective of this study is to determine the effectiveness of the Focal-Fusion Bx device at finding clinically relevant prostate cancer.
A multiparametric MRI examination will be carried out prior to study enrollment. Probable cancerous regions (regions of interest, ROI) will be identified, and these ROIs will be used as targets during the biopsy.
Three prostate sampling methods will be conducted in the same session on all patients. These include:
- Focal-Fusion Bx targeted biopsy ii) Cognitive fusion targeted biopsy and iii) Systematic (untargeted) biopsy. Trans-rectal ultrasound (TRUS) imaging will be conducted with BK Flex Focus Ultrasound system (Analogic Corporation, Peabody, MA).
Primary hypothesis: The technique used to acquire the biopsy samples will impact the proportion of clinically relevant cancers by improving the specificity of detecting clinically significant cancers. It is hypothesized that Focal-Fusion Bx biopsies will diagnose more high risk cancers and fewer low-risk cancers than non-targeted systematic biopsies.
- Conditions
- Prostate Cancer
- Being tested
- Focal-Fusion Bx
- Keywords
- Prostate Cancer, Biopsy, Focal Healthcare, Fusion Targeted Biopsy, High Risk Cancer, Imaging, Diagnostic, Ultrasound, Multiparametric Magnetic Resonance Imaging (MP-MRI), MRI-Ultrasound Fusion, Focal-Fusion Bx
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal-Fusion BxDevice
Also called MRI-ultrasound fusion device
The Focal-Fusion Bx device uses hardware and software to overlay targets onto the live ultrasound image in real-time. This allows the urologist to take biopsy samples from tissue that looked suspicious on the patient's MRI.
| Study group | Role | What they receive |
|---|---|---|
| MRI-ultrasound fusion device | Experimental | Using the Focal-Fusion Bx device, the urologist will fuse ('coregister') the MRI to the TRUS imaging Receives: Device: Focal-Fusion Bx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of biopsy cores positive for clinically significant cancer.
Measured: 12 months
Secondary outcomes (1)
Number of men diagnosed with clinically significant and clinically insignificant cancer.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Focal Healthcare Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Winston Barzell, MD, Principal investigator, 21st Century Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524860
- Sponsor's protocol ID
- 20150330, version 2.0
- Status last verified
- Mar 2017
- First submitted
- 14 Aug 2015
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device in Patients With an Elevated PSA and a Positive Multiparametric MRI
- ClinicalTrials.gov ID
- NCT02524860
- Acronym / sponsor ID
- 20150330, version 2.0
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Biopsy, Focal Healthcare, Fusion Targeted Biopsy, High Risk Cancer, Imaging, Diagnostic, Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Focal Healthcare Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 17 Aug 2015 (estimated)
- 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.
The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting clinically significant prostate cancer in a standard clinical environment.
Detailed description
The objective of this study is to determine the effectiveness of the Focal-Fusion Bx device at finding clinically relevant prostate cancer.
A multiparametric MRI examination will be carried out prior to study enrollment. Probable cancerous regions (regions of interest, ROI) will be identified, and these ROIs will be used as targets during the biopsy.
Three prostate sampling methods will be conducted in the same session on all patients. These include:
- Focal-Fusion Bx targeted biopsy ii) Cognitive fusion targeted biopsy and iii) Systematic (untargeted) biopsy. Trans-rectal ultrasound (TRUS) imaging will be conducted with BK Flex Focus Ultrasound system (Analogic Corporation, Peabody, MA).
Primary hypothesis: The technique used to acquire the biopsy samples will impact the proportion of clinically relevant cancers by improving the specificity of detecting clinically significant cancers. It is hypothesized that Focal-Fusion Bx biopsies will diagnose more high risk cancers and fewer low-risk cancers than non-targeted systematic biopsies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-ultrasound fusion device | Experimental | Device: Focal-Fusion BxUsing the Focal-Fusion Bx device, the urologist will fuse ('coregister') the MRI to the TRUS imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male subjects up to 80 years of age
- Candidates for fusion biopsy
- Elevated PSA levels
- MP-MRI with lesions having a Prostate Imaging Reporting and Data System (PI-RADS) score greater than or equal to 3 (determined by a trained radiologist)
- Subject is willing and able to read, understand and sign the Informed Consent Form document
Key exclusion criteria (3 listed)
- Previous treatment for prostate cancer
- Any contraindication to a standard TRUS prostate biopsy procedure
- Refusal to sign the Informed Consent document
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 |
|---|---|---|
| Focal-Fusion BxAlso: MRI-ultrasound fusion deviceThe Focal-Fusion Bx device uses hardware and software to overlay targets onto the live ultrasound image in real-time. This allows the urologist to take biopsy samples from tissue that looked suspicious on the patient's MRI. | Device | MRI-ultrasound fusion device |
Primary outcome
Proportion of biopsy cores positive for clinically significant cancer.
Time frame: 12 months
1 secondary outcome
Number of men diagnosed with clinically significant and clinically insignificant cancer.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Winston Barzell, MD principal investigator
21st Century Oncology, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal-Fusion Bx in people with Prostate Cancer, run by Focal Healthcare Inc. 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 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: status not confirmed, as of the sponsor's last update on 16 Mar 2017. 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?
Results are not available in the source record.
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?
Proportion of biopsy cores positive for clinically significant cancer. (time frame: 12 months). 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 16 Mar 2017.