Prostate Cancer Molecular Medicine

Prostate Cancer Molecular Medicine - PCMM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39774

Enrollment

496

Registered

2010-08-05

Start date

2011-02-07

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer prostate carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Construction of a Dutch multicenter prospective biorepository for validation of biomarker and imaging products.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results