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Prostate Cancer Molecular Medicine (PCMM).

Prostate Cancer Molecular Medicine (PCMM).

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27495
Enrollment
400
Registered
2010-08-19
Start date
2010-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Prostate cancer / prostaatkanker

Interventions

Prospective blood, urine, and histology sampling and imaging.

Sponsors

Erasmus MC, NKI-AvL, UMCG, UMCN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group 1: 1. Planned to undergo prostate biopsies according to standard practice; 2. Signed informed consent. Group 2: 1. cT1-3Nx-0Mx-0 prostate cancer; 2. Scheduled for radical prostatectomy according to standard practice; 3. Signed informed consent.

Exclusion criteria

Exclusion criteria: Group 1 and group 2: 1. Known allergy to contrast agents or sulphur hexafluoride micro bubbles; 2. Documented acute prostatitis or urinary tract infections; 3. Any clinically unstable cardiac condition within 7 days prior to contrast agent administration such as: A. Evolving or ongoing myocardial infarction; B. Typical angina at rest; C. Significant worsening of cardiac symptoms; D. Recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings); E. Acute cardiac failure, class III/IV cardiac failure; F. Severe cardiac rhythm disorders; G. Right-to-left shunts; H. Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome. Group 2 only: 1. Renal insufficiency (GFR < 30 ml/min); 2. Severe cardiac condition; 3. Vulnerable for convulsions; 4. Presence of a pacemaker or other implants or clamps.

Design outcomes

Primary

MeasureTime frame
Construction of a Dutch multicenter prospective biorepository for validation of biomarker and imaging products.

Secondary

MeasureTime frame
1. Newly developed biomarkers and imaging tools that can improve the diagnosis, prognosis and therapy monitoring for prostate cancer; 2. An IT infrastructure for the integration of the complex information from biomarker analysis and (molecular) imaging, next to individual clinical data and biobank data, allowing for the future development of a Clinical Decision Support System (CDSS) that optimizes clinical decision making.

Contacts

Public ContactE.A.M. Schenk-Braat

P.O. Box 2040

e.schenk-braat@erasmusmc.nl+31 (0)10 7043674

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)