An observational study in Prostate Cancer, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 3 sites in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
Rationale: Current imaging techniques for the detection and grading of prostate cancer are imperfect, leading to unnecessary biopsies, suboptimal treatment decisions and missed clinically significant cancers. The hypothesis of this study is that computer assisted analysis of 3D multiparametric ultrasound (mpUS) images can accurately detect, grade and localize prostate cancer. 3D mpUS may then become a more cost-effective and more streamlined imaging strategy than the current standard: mpMRI.
Objective: The primary objective is to collect high-quality 3D mpUS and histology data, to train and improve the classifier algorithm with the goal of achieving an accurate ultrasound imaging tool for the detection of clinically significant prostate cancer.
Secondary objectives are related to the preliminary assessment of the performance of 3D mpUS with computer assisted analysis.
Study design: This is a prospective, multi-center study in men with a suspicion of prostate cancer who are scheduled for prostate biopsies, and men with confirmed prostate cancer who are scheduled to undergo a radical prostatectomy. Prior to prostate biopsies or the radical prostatectomy, 3D mpUS imaging will be performed. The ultrasound images will be analyzed and used for algorithm training using the biopsies and/or prostatecomy specimens as gold standard. Additional research coupes of pathology material (both biopsies and radical prostatectomy specimens) from study subjects will be anonymized and separately analyzed and stored in a central, independent institution. The outcome of the 3D mpUS analysis and the additional pathology evaluation are for research purposes only and will not interfere with standard patient care.
Study population: 1) Male patients of age ≥18 suspected for prostate cancer who are scheduled for systematic and/or targeted biopsy after mpMRI examination.
Main study parameters/endpoints:
For the secondary objective, preliminary assessment of the performance of 3D mpUS, the following endpoints are evaluated
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 608 is above the median of 200 across 1,179 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
A patient history that includes any of the following prostate related interventions:
Male patients of age ≥18 suspected for prostate cancer who are scheduled for systematic and/or targeted biopsy after mpMRI examination. No intervention study
Other: No intervention
Male patients of age ≥18 diagnosed with prostate cancer who are scheduled for radical prostatectomy
Other: No intervention
No intervention
To collect high quality 3D multiparametric ultrasound and histology data to train and improve the classifier algorithm with the goal of achieving an accurate ultrasound imaging tool for detection, grading and localization of prostate cancer.
This is a diagnostic accuracy study with cross-sectional interest between 3D multiparametric ultrasound results and histological findings at biopsy or histological examination of the full grand as the reference standards.
Time frame: The 3D multiparametric ultrasound images collected te moment the ultrasound is done. Histology findings will be collected 2 week after prostatebiopsies or radical prostatectomy. No patient follow-up is needed.
The number of histologically proven clinically relevant cancer that can be detected by 3D multiparametric ultrasound using full mount prostate histopathology as the reference standard.
Sensitivity / Negative predictive value
Time frame: The 3D multiparametric ultrasound images collected the moment the ultrasound is done. Histology findings will be collected 2 week after prostatebiopsies or radical prostatectomy. No patient follow-up is needed.
The frequency of false-positive result by 3D multiparametric ultrasound using full mount prostate histopathology as the reference standard.
Specificity / Positive Predictive Value
Time frame: The 3D multiparametric ultrasound images collected the moment the ultrasound is done. Histology findings will be collected 2 week after prostatebiopsies or radical prostatectomy. No patient follow-up is needed.
The concordance between findings from mpMRI and 3D multiparametric ultrasound.
Cancer detection rates, relative sensitivity / specificity
Time frame: mpMRI is present at time of inclusion, 3D mpUS images will be collected 1-3 weeks after inclusion. The concordance between mpMRI and 3DmpUS can be evaluated after imaging and histpathology data is in.
Plan to share: Undecided
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)