E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007113 |
E.1.2 | Term | Cancer of prostate |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Accuracy for detection of prostate cancer, per segment; T2 vs. T2+DCE-MRI |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
intra-individual comparison |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
histopathology, conventional contrast-enhanced-MRA |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |