C61
Conditions
Interventions
Group 1: The treatment and support of the patients within the scope of active surveillance will be performed accordingly to the latest, actual guidelines: regular determination of the PSA-value and sy
Sponsors
Universitätsklinikum TübingenRadiologischen Klinik, Abt. für Diagnostische & Interventionelle Radiologie
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| carcinoma detection rate of mpMRI (t0,t1) Rate of up-grading/staging re-biopsies at t0 and t1 with regards to the primary dignosis Definition of quantitative threshold values (ktrans, ADC for differentiation of low-risk and significant prostate cancer (Gleason>6 or T>T2a) conformity of histopathological results of systematic biopsy and targeted MRI-guided biopsy 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). | — |
Countries
Germany
Contacts
Public ContactAhmed Othman
Universitätsklinikum TübingenAbteilung für Diagnostische & Interventionelle Radiologie
Outcome results
None listed