Comparison of Prostate Fusion Biopsies With Software and Cognitive

NCT ID: NCT04291742

Last Updated: 2020-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

804 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-16

Study Completion Date

2022-02-27

Brief Summary

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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

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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

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Prostate Cancer Detection Fusion Prostate Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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0: cognitive

target prostate biopsies by cognitive fusion

Group Type EXPERIMENTAL

cognitive vs software

Intervention Type DIAGNOSTIC_TEST

cognitive vs software

1: software

target prostate biopsies by software

Group Type EXPERIMENTAL

cognitive vs software

Intervention Type DIAGNOSTIC_TEST

cognitive vs software

Interventions

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cognitive vs software

cognitive vs software

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age over 40 years.
* mpMRI carried out in our center.
* Presence of lesions with PIRADSv.2 ≥ 3.
* Acceptance to participate in the study.

Exclusion Criteria

* PSA\> 30 ng / ml
* Treatment with 5-ARIs (5-alpha-reductase inhibitors).
* Previous diagnosis of PCa.
* TR\> T3.
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Celma, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron, Barcelona

Locations

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Hospital Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ana Celma, MD

Role: CONTACT

0034932746000 ext. 6370

Ignasi Gallardo, Ph

Role: CONTACT

0034932746000 ext. 6370

Facility Contacts

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Ana Celma, MD

Role: primary

0034932746000 ext. 6370

Ignasi Gallardo, Ph

Role: backup

0034932746000 ext. 6370

Other Identifiers

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PR(AG)161/2019

Identifier Type: -

Identifier Source: org_study_id

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