Prostate Cancer Detection Clinical Trial
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.
Status | Recruiting |
Enrollment | 804 |
Est. completion date | February 27, 2022 |
Est. primary completion date | February 27, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Vall d'Hebron | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02013180 -
Zinc/PSA Ratio as a Novel Biomarker for Prostate Cancer Detection
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