Prostate cancer prostatic adenocarcinoma
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men >=18 years with confirmed prostate cancer scheduled for radical prostatectomy
Exclusion criteria
Exclusion criteria: - No mpMRI performed prior to prostate biopsy or radical prostatectomy - A history of chemotherapy for PCa or currently being treated with chemotherapy for PCa. - A patient history that includes any of the following prostate related interventions: o Brachytherapy or external radiotherapy for PCa; o Focal therapy for prostate cancer; o Prostate biopsy within the last 30 days. - Hormonal therapy for prostate cancer within the last six months - A patient history with a cardiac right to left shunt. - Current treatment with dobutamine - Known severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension or respiratory distress syndrome - Incapable of understanding the language in which the patient information is given. - Allergic reaction to previous ultrasound contrast administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the primary objective, training and improving the algorithm, we focus on • Gleason/Grade group scoring based on histology. Using histology as the reference standard we will optimize the accuracy of the algorithm in differentiating between benign tissue and various grades of malignancy. • Localization and size of lesions at full-gland histology. Correlation in tumour size and location will be optimized between 3D mpUS findings and histology of the full gland. | — |
Secondary
| Measure | Time frame |
|---|---|
| For the secondary objective, preliminary assessment of the performance of 3D mpUS, we will evaluate the following endpoints: • Among all clinically significant detected cancers confirmed by histology, we will calculate the proportion of these cancers that would have been detected by 3D mpUS. This sensitivity of 3D mpUS will be calculated for patients undergoing radical prostatectomy. The number of false positive findings by 3D mpUS both as an absolute count and expressed as a mean rate per patient. • The concordance in the detection and grading of abnormalities between mpMRI and 3D mpUS by examining the frequency and type of disagreements and calculating the kappa statistic. | — |
Countries
Netherlands
Outcome results
None listed