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The added value of MRI for detection of prostate cancer: validation with MR guided biopsies, fusion of MRI and transrectal ultrasound guided biopsies and TRUS guided biopsies.

The added value of MRI for detection of prostate cancer: validation with MR guided biopsies, fusion of MRI and transrectal ultrasound guided biopsies and TRUS guided biopsies. - Detection of prostate cancer: MRGB, TRUSGB and MRUSFGB

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32545
Enrollment
60
Registered
2009-06-19
Start date
2009-10-12
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer prostate carcinoma

Interventions

Patients will undergo a multimodality MRI consisting of T2W, DCEMRI, MRSI and DWI. During a second visit 12 standard TRUSGB will be taken. Ultrasound images will be fused with processed MR images by

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)