prostate cancer prostate carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • PSA>=4.0 ng/ml • One or more previous negative TRUS guided prostate biopsies
Exclusion criteria
Exclusion criteria: • Patients with known contradictions to MRI • Patients with known contra-indications to Gadolinium based contrast agents. • Patients with previous radiotherapy, hormonal therapy or local treatment of the prostate. • Patients with histological prove of prostate cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rates of MRGB (expected to be over 27%) compared to a second or later TRUSGB (expected to be 17% or less). Detection rate of MRUSFGB. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients upgraded by MRGB and MRUSFGB respectively compared to TRUSGB. The mean increase of Gleason score for MRGB and MRUSFGB respectively compared to TRUSGB. Predicitive accuracy for MRGB, MRUSFGB and TRUSGB Gleason score for true prostatectomy specimen Gleason score in case of prostatectomy. The increase of detection of clinical significant prostate cancers by MRGB and MRUSFGB in comparison to TRUSGB. | — |
Countries
Netherlands