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

Recruiting

Conditions: prostate cancer
Prostate carcinoma
10036958

Registration Number: NL-OMON51424

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 438

Inclusion Criteria

• male
• age of 18 years or older
• biopsy naïve
• clinical suspicion of prostate cancer for which prostate MRI is indicated
• signed informed consent

Exclusion Criteria

• 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
• PSA level above or equal to 100 ng/ml
• Medical history of prostate surgery
• current treatment of 5 alpha-reductase inhibitors for at least 3 months
• incapable of understanding the language in which the patient information is
given.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is clinically significant (GG >=2) PCa. The<br /><br>detection rate of this endpoint in any core for each biopsy strategy will be<br /><br>assessed to demonstrate the non-inferiority of PCaVision targeted biopsy<br /><br>strategy in comparison with MRI targeted biopsy strategy. The detection rate is<br /><br>expressed with patients as the unit of analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The detection rate of the primary endpoint will compared across different<br /><br>biopsy strategies: in any core for PCaVision versus systematic biopsy, MRI<br /><br>versus systematic biopsy and PCaVision + MRI versus systematic biopsy.<br /><br><br /><br>In addition, we will compare across biopsy strategies:<br /><br>• the capability to detect GG = 1 PCa, GG >= 2 PCa (with and without cribriform<br /><br>growth pattern and/or intraductal carcinoma (CR/IDC)), and GG >= 3 PCa<br /><br>• the GG distribution<br /><br>• the number of men included in the study but excluded for analysis resulting<br /><br>from poor diagnostic imaging / technical issues</p><br>