To determine detection rates of MRGB comparing to TRUSGB and MR-US-Fusion-GB within patients who are at risk for prostate cancer but have no histological prove of prostate cancer, and who underwent at least one negative TRUSGBTo determine the…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Outcomes of Gleason scores on histopathology of transrectal ultrasound guided
prostate biopsy (TRUSGB) remain the basis for urological decisions in treatment
of prostate cancer.
Urologists experience great difficulty in making treatment decisions when PSA
levels rise in spite of inexistence of cancer in TRUS guided biopsies. This
phenomenon is frequently caused by false positive results of TRUSGB. Moreover
also a undersampling exists in TRUSGB to great extent. Because of this cancers
that were initially of lower grade are upstaged on repeat biopsies.
Undergrading in TRUS guided biopsies unmistakenly leads to incorrect risk
stratification of patients and therefore to incorrect treatment decisions.
MRI has established itself as an accurate technique for localisation and
detection of prostate cancer.
Instead of taking random biopsies as in TRUSGB, MRGB and MRUSFUSIONGB can take
lesion targeted biopsies. Preliminary results have shown a significant decrease
in undersampling of MRGB.
The above leads to the hypothesis that MRGB has a higher detection rate (at
least 10% increase) comparing to TRUSGB.
Study objective
To determine detection rates of MRGB comparing to TRUSGB and MR-US-Fusion-GB
within patients who are at risk for prostate cancer but have no histological
prove of prostate cancer, and who underwent at least one negative TRUSGB
To determine the percentage of patients upgraded for MRGB compared to TRUSGB.
To determine the mean increase in Gleason score for MRGB compared to TRUSGB.
To determine the predicitive accuracy for true prostatectomy Gleason score for
MRGB. MRUSFUSIONGB and TRUSGB for patients that underwent prostatectomy.
To determine detection rates of MRUSFUSIONGB.
To determine correlation of MRUSFUSIONGB and MRGB.
Study design
A prospective cohort study.
Intervention
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 another examiner than the examiner taking
TRUSGB. After TRUSGB, the examiner will switch to the Fusion mode within the
same examination and 3 MRUSFUSIONGB of each TSR will be taken. After 4 weeks
the patient will undergo MRGB ( 3 samples of each TSR).
All specimens will be examined by one specialised pathologist. In case of
prostatectomy, prostatectomy specimens GS will en compared to MRGB, TRUSGB and
MRUSFUSIONGB GS.
Study burden and risks
For study purposes burden exists of time investment of 3 visits to the
hospital. The burden (heating and noise) of MRI examination. The burden of 6 to
12 extra biopsies (depending on one or two tumor suspected regions: 3 biopsies
per region). And the burden of MR guided biopsy: long examination in
uncomfortable prone position. Patients benefits allow for this study. Potential
patient risks in this study as mentioned complications of biopsy or of magnetic
resonance imaging or serious unexpected events and patient burden in form of
time investment and possible discomfort of MR examinations and biopsies are
outweighed by potential benefits for patients.
Patients will possibly benefit from an earlier detection of prostate cancer, a
more accurate biopsy through MR guidance and consequently their individual risk
stratification and selection for appropriate curative treatment will be
optimalize
Geert Grooteplein 10
6525 GA Nijmegen
Nederland
Geert Grooteplein 10
6525 GA Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
• PSA>=4.0 ng/ml
• One or more previous negative TRUS guided prostate biopsies
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL26080.091.08 |
| OMON | NL-OMON21521 |