Prostate Cancer DetectionNCT04291742
Comparison of Prostate Fusion Biopsies With Software and Cognitive
A study testing cognitive vs software in people with Prostate Cancer Detection and Fusion Prostate Biopsy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
This study evaluates the efficacy to diagnose significant prostate cancer in patients with suspicious lesions in mpMRI (multiparametric magnetic resonance imaging) by comparing prostate biopsies performed by cognitive fusion with respect to those performed with software fusion (BK-fusion®). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer Detection, Fusion Prostate Biopsy
- What is being tested?
- cognitive vs software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jan 2020to 27 Feb 2022
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 40 years.
- mpMRI carried out in our center.
- Presence of lesions with PIRADSv.2 ≥ 3.
- Acceptance to participate in the study.
Who cannot join
- PSA> 30 ng / ml
- Treatment with 5-ARIs (5-alpha-reductase inhibitors).
- Previous diagnosis of PCa.
- TR> T3.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
Ana Celma, MD, 0034932746000 ext. 6370, acelma@vhebron.net
Ignasi Gallardo, Ph, 0034932746000 ext. 6370, ignasi.gallardo@gmail.com
About this study
Official title: Prospective and Randomized Study to Compare the Efficacy of Cognitive Fusion Prostate Biopsies and Prostate Biopsies Performed by "BK-fusion®" Software, for the Diagnosis of Significant Prostate Cancer
This study evaluates the efficacy to diagnose significant prostate cancer in patients with suspicious lesions in mpMRI (multiparametric magnetic resonance imaging) by comparing prostate biopsies performed by cognitive fusion with respect to those performed with software fusion (BK-fusion®). Half of the patients included will undergo a systematic prostate biopsy + target biopsies by cognitive fusion and the other half of the population, will undergo a systematic prostate biopsy + target biopsies by software fusion.
Read the detailed description
Various techniques have been developed to perform targeted prostate biopsies aimed at suspicious lesions detected in mpMRI. The two most frequently used are cognitive fusion, in which the physician locates the areas where the mpMRI detects suspicious lesions and directs the puncture by ultrasound; and software fusion, in which the images of the mpMRI are integrated by a software with the ultrasound allowing to direct the puncture to the lesion itself. Both forms of fusion biopsy have proven to be superior to systematized prostate biopsies in the detection of significant prostate cancer, although neither has demonstrated superiority over the other.
- Conditions
- Prostate Cancer Detection, Fusion Prostate Biopsy
- Being tested
- cognitive vs software
- Keywords
- prostate biopsy, mpMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive vs softwareDiagnostic test
cognitive vs software
| Study group | Role | What they receive |
|---|---|---|
| 0: cognitive | Experimental | target prostate biopsies by cognitive fusion Receives: Diagnostic Test: cognitive vs software |
| 1: software | Experimental | target prostate biopsies by software Receives: Diagnostic Test: cognitive vs software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of overall prostate cancer and significant prostate cancer between the groups
Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed.
Measured: 2 years
Secondary outcomes (4)
Rate of overall prostate cancer and significant prostate cancer between the groups according to the location of the lesions.
Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the location of the lesions.
Measured: 2 years
Rate of overall prostate cancer and significant prostate cancer between the groups according to the size of the lesions.
Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the size of the lesions.
Measured: 2 years
Rate of overall prostate cancer and significant prostate cancer between the groups according to the PIRADS (prostate imaging and reporting and data System) of the lesions.
Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the PIRADS (prostate imaging and reporting and data System) of the lesions.
Measured: 2 years
Rate of overall prostate cancer and significant prostate cancer between the groups according to the prostate volume.
Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the prostate volume.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start16 Jan 2020
- Primary completion27 Feb 2022 (estimated)
- Study completion27 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer DetectionStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- 804 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Celma, MD, Principal investigator, Hospital Vall d'Hebron, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291742
- Sponsor's protocol ID
- PR(AG)161/2019
- Status last verified
- Feb 2020
- First submitted
- 2 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Randomized Study to Compare the Efficacy of Cognitive Fusion Prostate Biopsies and Prostate Biopsies Performed by "BK-fusion®" Software, for the Diagnosis of Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04291742
- Acronym / sponsor ID
- PR(AG)161/2019
- Conditions
- Prostate Cancer Detection, Fusion Prostate Biopsy
- Keywords
- prostate biopsy, mpMRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 804 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 27 Feb 2022 (estimated)
- Study completion
- 27 Feb 2022 (estimated)
- First posted
- 2 Mar 2020 (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 study evaluates the efficacy to diagnose significant prostate cancer in patients with suspicious lesions in mpMRI (multiparametric magnetic resonance imaging) by comparing prostate biopsies performed by cognitive fusion with respect to those performed with software fusion (BK-fusion®). Half of the patients included will undergo a systematic prostate biopsy + target biopsies by cognitive fusion and the other half of the population, will undergo a systematic prostate biopsy + target biopsies by software fusion.
Detailed description
Various techniques have been developed to perform targeted prostate biopsies aimed at suspicious lesions detected in mpMRI. The two most frequently used are cognitive fusion, in which the physician locates the areas where the mpMRI detects suspicious lesions and directs the puncture by ultrasound; and software fusion, in which the images of the mpMRI are integrated by a software with the ultrasound allowing to direct the puncture to the lesion itself. Both forms of fusion biopsy have proven to be superior to systematized prostate biopsies in the detection of significant prostate cancer, although neither has demonstrated superiority over the other.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0: cognitive | Experimental | Diagnostic Test: cognitive vs softwaretarget prostate biopsies by cognitive fusion |
| 1: software | Experimental | Diagnostic Test: cognitive vs softwaretarget prostate biopsies by software |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 40 years.
- mpMRI carried out in our center.
- Presence of lesions with PIRADSv.2 ≥ 3.
- Acceptance to participate in the study.
Key exclusion criteria (4 listed)
- PSA> 30 ng / ml
- Treatment with 5-ARIs (5-alpha-reductase inhibitors).
- Previous diagnosis of PCa.
- TR> T3.
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 |
|---|---|---|
| cognitive vs softwarecognitive vs software | Diagnostic test | 0: cognitive, 1: software |
Primary outcome
Rate of overall prostate cancer and significant prostate cancer between the groups
Time frame: 2 years
Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed.
4 secondary outcomes
Rate of overall prostate cancer and significant prostate cancer between the groups according to the location of the lesions.
Time frame: 2 years
Rate of overall prostate cancer and significant prostate cancer between the groups according to the size of the lesions.
Time frame: 2 years
Rate of overall prostate cancer and significant prostate cancer between the groups according to the PIRADS (prostate imaging and reporting and data System) of the lesions.
Time frame: 2 years
Rate of overall prostate cancer and significant prostate cancer between the groups according to the prostate volume.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- 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.
Ana Celma, MD principal investigator
Hospital Vall d'Hebron, Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive vs software in people with Prostate Cancer Detection and Fusion Prostate Biopsy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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: status not confirmed, as of the sponsor's last update on 2 Mar 2020. 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 Spain. 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?
Contact Ana Celma, MD (0034932746000 ext. 6370, acelma@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of overall prostate cancer and significant prostate cancer between the groups (time frame: 2 years). 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 2 Mar 2020.