Prostate cancer diagnosis by multiparametric ultrasound

Conditions: Prostate cancer
prostatic adenocarcinoma
10038597

Registration Number: NL-OMON54171

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

Men >=18 years with confirmed prostate cancer scheduled for radical
prostatectomy

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For the primary objective, training and improving the algorithm, we focus on<br /><br>• Gleason/Grade group scoring based on histology. Using histology as the<br /><br>reference standard we will optimize the accuracy of the algorithm in<br /><br>differentiating between benign tissue and various grades of malignancy.<br /><br>• Localization and size of lesions at full-gland histology. Correlation in<br /><br>tumour size and location will be optimized between 3D mpUS findings and<br /><br>histology of the full gland.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>For the secondary objective, preliminary assessment of the performance of 3D<br /><br>mpUS, we will evaluate the following endpoints:<br /><br>• Among all clinically significant detected cancers confirmed by histology, we<br /><br>will calculate the proportion of these cancers that would have been detected by<br /><br>3D mpUS. This sensitivity of 3D mpUS will be calculated for patients undergoing<br /><br>radical prostatectomy. The number of false positive findings by 3D mpUS both as<br /><br>an absolute count and expressed as a mean rate per patient.<br /><br>• The concordance in the detection and grading of abnormalities between mpMRI<br /><br>and 3D mpUS by examining the frequency and type of disagreements and<br /><br>calculating the kappa statistic.</p><br>