NCT06281769Completed
Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 467 (actual)
- First submitted
- 12 Feb 2024
- Start date
- 26 Feb 2024
- Primary completion date
- 15 Aug 2025
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Prostate cancer
- NCT number
- NCT06281769
What you commit to
- Study type: Interventional
- Participants enrolled: 467
- From 26 Feb 2024 to the primary completion date, 15 Aug 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current treatment with dobutamine
- treatment of 5 alpha-reductase inhibitors for at least 3 months
Other illness
- 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
- known severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension or respiratory distress syndrome
- medical history of prostate surgery
Other
- any (further) contraindication to undergo MRI or 3D mpUS imaging
- incapable of understanding the language in which the patient information is given.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC location VUmc Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Andros Clinics Coordinator of this site? Confirm its status | Baarn | Netherlands | Unknown status |
| Spaarne Gasthuis Coordinator of this site? Confirm its status | Hoofddorp | Netherlands | Unknown status |
| St. Antonius Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Fransiscus Gasthuis Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.