Multiparametric MRI for active surveillance of Patients with a low-risk Prostate Cancer: A Prospective, Longitudinal, Multicentric, Comparative Study

Not Applicable

Recruiting

Conditions: C61
Malignant neoplasm of prostate

Registration Number: DRKS00013915

Lead Sponsor: niversitätsklinikum TübingenRadiologischen Klinik, Abt. für Diagnostische & Interventionelle Radiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 217

Inclusion Criteria

• Age =18 years
• histological proven PCa
• Gleason Score =6
• Tumor in = 2 biopsy samples/punches
• = 50 % Tumor per punch.
• not yet performedre-biopsy or control-MRI after primary dignosis
• Stages T3/T4 excluded
• Serum PSA =10 ng/ml
• written and signed informed consent

Exclusion Criteria

• Gleason Score =7
• Extra capsular extension
• Tumorstages T3/T4
• previous radiotherapy of the pelvis
• previous prostate surgery
• Impairment of blood coagulation/ anticoagulation
• Contraindications for MRI, e.g.:
- all kind of metal on or within the body, pacemakers, artificial cardiac valves,
metal prothesis, implanted magnetic metals (screws, surgical plates),
metal splinters, permanent dental braces, acupunctur-needle, insuline pumps,
intraport etc., tattoos
- patients with restricted thermal sensor or increased thermal sensitivity
- patients with an auditory disease or an increased auditory sensitivity
- Claustrophobia
- extreme adipositas
- Contraindications for Gadolinium contrast agents (GFR-Rate: <30 ml/min/1,73m²)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Grade of conformity of both approaches (mpMRI +/- targeted MRI-guided biopsy versus systemic biopsy) with regards to progression rate to significant prostate cancer (e.g. Gleason Score>7 or T>T2a) after 15+/1 months of active surveillance

Secondary Outcome Measures

Name	Time	Method
carcinoma detection rate of mpMRI (t0,t1)<br><br>Rate of up-grading/staging re-biopsies at t0 and t1 with regards to the primary dignosis<br><br>Definition of quantitative threshold values (ktrans, ADC for differentiation of low-risk and significant prostate cancer (Gleason>6 or T>T2a)<br><br>conformity of histopathological results of systematic biopsy and targeted MRI-guided biopsy<br><br>Definition of quantitative threshold values for e.g. ktrans, ADC and texture for the prediction of the tumor progression to significant prostate cancer (e.g. Gleason Score > 6 oder T>T2a).