Detecting prostate cancer using targeted biopsies with PCaVision imaging
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
This study is testing if a new imaging method called PCaVision can find prostate cancer just as well as traditional MRI scans when doctors take targeted biopsies of suspicious areas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 438 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 5 sites (Amsterdam and 4 other locations) |
| Trial ID | NCT06281769 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of targeted biopsies for detecting clinically significant prostate cancer using PCaVision imaging versus traditional MRI imaging. Patients will undergo both imaging techniques to identify suspicious lesions, with biopsies performed based on the results of each method. The study will assess whether the detection rate of prostate cancer using PCaVision is non-inferior to that of MRI. The biopsies will be conducted by a single physician, ensuring consistency in the procedure.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 18 or older who are biopsy naïve and have a clinical suspicion of prostate cancer.
Not a fit: Patients with active infections, a history of prostate surgery, or contraindications to MRI or ultrasound imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the accuracy of prostate cancer detection, leading to better patient outcomes.
How similar studies have performed: Previous studies have shown promising results with similar imaging techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam and 4 other locations
- Amsterdam UMC - location VUmc — Amsterdam, Netherlands (Recruiting)
- Andros Clinics — Baarn, Netherlands (Recruiting)
- Spaarne Gasthuis — Hoofddorp, Netherlands (Recruiting)
- St. Antonius — Nieuwegein, Netherlands (Recruiting)
- Fransiscus Gasthuis — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Daniel van den Kroonenberg, MD
- Email: d.kroonenbergvanden@amsterdamumc.nl
- Phone: 310639345375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.