Prostata cancer MedDRA version: 9.1 Level: LLT Classification code 10007113 Term: Cancer of prostate
Conditions
Interventions
Trade Name: Gadovist® 1.0 mmol/ml contrast medium
Product Code: V08C A09
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gadobutrol
CAS Number: 138071-82-6
Concentration unit: mmol/ml
Sponsors
Charité Campus Mitte, Instituts für Radiologie
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age: 18-85 years 2. First diagnosis of prostate cancer from histopathological examination of biopsy specimens 3. Scheduled for prostatectomy not earlier than 4 weeks after prostate biopsy for clinical reasons 4. Willing to comply with the study procedures 5. Patients who have given their fully informed, written and dated consent voluntarily Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study 2. GFR <60ml/m²/1.73m² (MDRD or Cockroft-Gault formula), creatiine values =1 week 3. Not being able to remain lying down for at least 45-60 min (e.g., patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain) 4. Known allergy to any ingredient of Gadovist 5. Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents 6. Being clinically unstable 7. Having any contraindication to MRI examination or specifically to MRV (e.g., pacemaker, recent wound clips, and severe claustrophobia). 8. Having any physical or mental status that interferes with the informed consent procedure including self-signed consent 9. Close affiliation with the investigational site; e.g. a close relative of the investigator 10. Having been previously enrolled in this study 11. Participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main object of the trial is to assess the diagnostic value of functional MRI (T2+DCE MRI) for the detection of prostate cancer (on the basis of 16 prostate segments) and to show superiority in the accuracy to detect prostate cancer compared to conventional T2 MRI (SOR: histopathology);Secondary Objective: The secondary objectives of the trial are: Secondary objectives: • To assess the value of functional MRI for identification of the tumor with the largest diameter (reference tumor; only patients with multiple tumors in the prostate) • To assess the minimum tumor size detectable in MRI • To assess the value of functional MRI for correct T-staging (T2 vs. T3) • To assess the diagnostic confidence of the MRI diagnosis ;Primary end point(s): Accuracy for detection of prostate cancer, per segment; T2 vs. T2+DCE-MRI | — |
Countries
Germany
Outcome results
None listed