Prostate Cancer Molecular Medicine

Completed

Conditions: 10036958
Prostate cancer
prostate carcinoma
10038597

Registration Number: NL-OMON39774

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 496

Inclusion Criteria

Group 1:
• planned to undergo prostate biopsies according to standard practice
• signed informed consent;Group 2:
• cT1-3Nx-0Mx-0 prostate cancer
• scheduled for radical prostatectomy according to standard practice
• signed informed consent

Exclusion Criteria

Group 2 only:
• known allergy to contrast agents or sulphur hexafluoride micro bubbles
• documented acute prostatitis or urinary tract infections within 8 weeks prior to inclusion
• severe cardiac condition
• any clinically unstable cardiac condition within 7 days prior to contrast agent administration such
as:
- evolving or ongoing myocardial infarction
- typical angina at rest
- significant worsening of cardiac symptoms
- recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent
deterioration of ECG, laboratory or clinical findings)
- acute cardiac failure, class III/IV cardiac failure
- severe cardiac rhythm disorders
- right-to-left shunts
• known severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled
systemic hypertension or respiratory distress syndrome
• renal insufficiency (GFR < 30 ml/min)
• vulnerable for epilepsy
• presence of a pacemaker or other implants or clamps

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Construction of a Dutch multicenter prospective biorepository for validation<br /><br>of biomarker and imaging products.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Provision of a Medical Technology Assessment (MTA) of newly developed<br /><br>biomarkers, contrast enhanced ultrasound and multimodality MRI in early and<br /><br>advanced PCa for diagnosis and therapeutic decision making as compared to<br /><br>current standard diagnostic techniques.<br /><br>2. Initiation of a Clinical Decision Support System (CDSS) that optimizes<br /><br>clinical decision making by integrating the complex information from biomarkers<br /><br>and (molecular) imaging, next to individual clinical data in the clinical phase<br /><br>of the disease.</p><br>