Clinical trial · Observational
Development and Validation of Novel MRI Methods for the Detection of Prostate Cancer Aggressiveness
NCT02545881CI-TRIAL-00024349PROAGunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to develop, validate, and evaluate the correlation of novel magnetic resonance imaging (MRI) methods with prostate cancer aggressiveness and histological data obtained during prostatectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- MR relaxation values
- timeFrame
- Within 1 month prior to prostatectomy
- description
- Aim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer
- measure
- MR DWI parameters
- timeFrame
- Within 1 month prior to prostatectomy
- description
- Aim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer
- measure
- Histological prostate cancer aggressiveness (Gleason grade)
- timeFrame
- Within 1 month after MR imaging of the prostate
- description
- Aim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 35 to 85 years * Language spoken: Finnish * Performance status: Karnofsky score 70 or better or WHO performance status 2 or better * Diagnosis: Histologically confirmed adenocarcinoma of prostate * No previous surgical, radiation or endocrine treatment for prostate carcinoma * Clinical stage T1c-T3aN0 based on transrectal ultrasound, pelvic CT and bone scintigraphy * Time period between the last biopsy and scheduled radical prostatectomy less than 8 months * Mental status: Patients must be able to understand the meaning of the study * Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff Exclusion Criteria: * previous prostate surgeries, e.g. TURP (transurethral prostatic resection) * symptomatic acute prostatitis * contraindications for MRI (cardiac pacemaker, intracranial clips etc) * uncontrolled serious infection * claustrophobia
References
Publications (0)
Data not yet available
No reference posted for this study.