Clinical trial NCT06281769: Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision
Official title: Clinical Validation of Transrectal Multiparametric Ultrasound Imaging Strategy (PCaVision) for the Detection of Clinically Significant Prostate Cancer: a Head-to-head Comparison With the MRI-based Strategy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: contrast enhanced ultrasound
CEUS
Multiparametric Ultrasound
Artificial intelligence
MRI
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Angiogenesis Analytics
First posted: 2024-02-28
Enrollment: 438
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway).

Detailed description: All patients will undergo imaging using MRI and PCaVision during which suspicious lesions will be identified based on each imaging technique independently with readers being blinded for the results of the other imaging technique. Thereafter, a MRI targeted 3-core biopsy per lesion (maximum of 2 lesions) and/ or a PCaVision targeted 3-core biopsy (maximum of 2 lesions) will be performed by a one physician if suspicious lesions have been identified based on imaging. If lesions have been identified with both PCaVision and MRI in the same patient, the order of the targeted biopsies will be randomized. If the same lesion has been identified on both MRI and PCaVision, both a MRI-targeted and a PCaVision targeted biopsy will be separately performed. Histological examination of the targeted biopsies will be performed to determine presence of clinically significant prostate cancer.

Eligibility criteria: Inclusion Criteria:

* be male
* have an age of 18 years or older
* be biopsy naïve
* have a clinical suspicion of prostate cancer
* be scheduled for evaluation by prostate MRI based on a suspicious DRE and/or elevated serum PSA
* have signed informed consent

Exclusion Criteria:

* active (urinary tract) infection or prostatitis
* a patient history with a cardiac right-to-left shunt.
* allergic to sulphur hexafluoride or any of the other ingredients of the ultrasound contrast agent SonoVue
* current treatment with dobutamine
* known severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension or respiratory distress syndrome
* any (further) contraindication to undergo MRI or 3D mpUS imaging
* incapable of understanding the language in which the patient information is given.
* medical history of prostate surgery
* treatment of 5 alpha-reductase inhibitors for at least 3 months

Primary outcomes:
measure: Detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI.
timeFrame: Two weeks
Secondary outcomes:
measure: Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway.
timeFrame: Two weeks
measure: Detection rate of three different definitions of prostate cancer in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of targeted biopsies based on MRI (MRI pathway).
timeFrame: Two weeks
measure: Number of men in whom the PCaVision pathway generated insufficient quality images with the number of men with insufficient quality MRI images in the MRI pathway.
timeFrame: Two weeks
measure: Detection rate of clinically significant prostate cancer in targeted biopsies based on PCaVision imaging using various incremental levels of PCaVision's image quality requirements in comparison with the detection rate of targeted biopsies based on MRI.
timeFrame: Two weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - location VUmc
city: Baarn
country: Netherlands
facility: Andros Clinics
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius
city: Rotterdam
country: Netherlands
facility: Fransiscus Gasthuis
Study officials:
References:
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