Ivan Jambor1, Peter Boström2, Pekka Taimen1, Esa Kähkönen2, Markku Kallajoki2, Tommi Kauko1, Ileana Montoya1, Otto Ettala2, Harri Merisaari1, Kari Syvänen2, and Hannu Juhani Aronen1
1University of Turku, Turku, Finland, 2Turku University Hospital, Turku, Finland
Synopsis
In
this prospective single institution registered clinical trial we aimed to
evaluate the role of rapid pre-biopsy prostate MRI consisting of T2-weighted
imaging and DWI, no endorectal coil, no iv contrast. The primary end point was
the diagnostic accuracy of the models incorporating clinical variables, PSA,
and MRI findings. In total 175 patients were enrolled and 161 were included in
final analyses. Rapid pre-biopsy prostate MRI was shown to be an accurate tool
for the management of patients with a clinical suspicion of prostate cancer.Purpose
Multiparametric MRI is increasingly being used for the
detection of prostate cancer in patients with a suspicion of prostate cancer
(PCa) but limitations such as long acquisition time remains (1). Our objective was to investigate the accuracy
of a rapid MRI protocol and simple biopsy procedure in patients with a clinical
suspicion of PCa (IMPROD= IMPROved prostate cancer Diagnosis – Combination of
Magnetic Resonance Imaging and biomarkers)
Methods
Men with a clinical suspicion of PCa were enrolled to
the prospective, controlled, registered (ClinicalTrials.gov Identifier
NCT01864135) clinical trial (Figure 1). After signing an informed consent, MRI
scanning was performed followed by prostate biopsies (Figure 2). The MRI
examination was performed using a 3T MR scanner (3T Verio, Siemens, Erlangen, Germany).
Only routinely available MR acquisition and post-processing methods were used
allowing wide application of our MRI protocol in other centers. The overall
imaging time including shimming and calibration was approximately 15 minutes.
No intravenous contrast agent or endorectal coil were used. T2-weighted imaging
(T2w) in transversal and sagittal planes were performed as previously described
(2), transversal T2w - TR/TE
8640/101 ms, acquisition voxel size 0.6×0.6×3.0mm3; sagittal T2w - TR/TE
8640/101ms, acquisition voxel size 0.7×0.6×3.0mm3. Diffusion
weighted imaging (DWI) data sets were collected in three separate acquisitions using
a spin echo double refocused sequence with epi read-out, bipolar gradient scheme and the following
parameters: 1. TR/TE 5543/80 ms, b values 0, 100, 200, 300, 500 s/mm2,
acquisition voxel size 2.0×2.0×3.0mm3, no intersection gaps; 2.
TR/TE 5000/87 ms, b values 0, 1500 s/mm2, acquisition voxel size
2.0×2.0×5.0mm3, no intersection gaps; 3. TR/TE 5000/87 ms, b values
0, 2000 s/mm2, acquisition voxel size 2.0×2.0×5.0mm3, no
intersection gaps. Suspicious lesions in MRI were reported using Likert scoring
systems as follows: 1- significant cancer is highly unlikely to be
present, 2- significant cancer is unlikely to be present, 3- significant cancer
is equivocal, 4- significant cancer is likely to be present, 5- significant
cancer is highly likely to be present. Transrectal ultrasound (TRUS) biopsies were performed
cognitively, without MRI-TRUS fusion. In a case of MRI suspicious lesion
(Likert score 3-5), initially 2 targeted biopsy (TB) cores were aimed at the dominant
MRI-lesion followed by 6+6 systematic biopsies (SB). Finally, 2 biopsy cores
for biomarker research were taken (Figure 1). All biopsy cores were reported separately
(core length, cancer length, Gleason score) by 2 expert GU-pathologist using 2005
International Society of Urological Pathology Modified Gleason Grading System modified
Gleason grading system (3).
The primary end point was a diagnostic accuracy of the
following models for predicting PCa and clinically significant PCa (SPCa): 1.
blood model: PSA, age, 5-alpha-reductase inhibitors use. 2. visit model: PSA, age,
5-alpha-reductase
inhibitors use, digital rectal examination; 3. transrectal ultrasound model: PSA,
age, 5-alpha-reductase inhibitors use, digital rectal examination, TRUS
findings, prostate volume (as measured by TRUS), PSA density. 4. MRI model:
PSA, age, 5-alpha-reductase inhibitors use, digital rectal examination, TRUS
findings, prostate volume (as defined by TRUS), PSA density, Likert score. The
following three definitions of SPCa were used: definition no. 1- Gleason score
3+4 or higher, definition no. 2- Gleason score of 4+3 or higher and 3+4
with >=50% of any core containing
cancer and/or >=4 SB positive for
cancer (1), definition no. 3- Gleason
score of 4+3 or higher. Receiver operating characteristic curve analysis with
area under the curve (AUC) values were used to evaluate ability of the models
to predicting PCa and SPCa. Likert scores 1-2 were combined in the model
predictions resulting into 3 degrees of freedom (Likert scores: 1-2, 3, 4, 5).
Logistic regression models were estimated using variables as defined above. The
“gold standard” was based on TB and SB findings and in 3 patients based on
follow up TB findings. P-values less than 0.05 were considered statistically
significant. All analyses were conducted using R version 3.2.0 (R Foundation
for Statistical Computing, Vienna,
Austria).
Results
In total, 175 men were prospectively enrolled while
161 men were included in the final analyses (Figure 2). The MRI model significantly outperformed all
other models in PCa and SPCa detection (Figure 3). Only 4 (3%) and 2 (2%) men had
Likert score 1-2 and presented with SPCa according to the definition no. 1
(Figure 4) and definition no. 2 (Figure 5) while none had SPCa according to the
definition no. 3.
Conclusion
Rapid pre-biopsy biparametric MRI (T2wi+DWI) is an
accurate tool for the management of patients with a clinical suspicion of PCa
based on PSA and/or abnormal digital rectal examination.
Acknowledgements
No acknowledgement found.References
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MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the
diagnosis of prostate cancer. JAMA 2015; 313:390-397.
2. Jambor
I, Kahkonen E, Taimen P, et al. Prebiopsy multiparametric 3T prostate MRI in patients with
elevated PSA, normal digital rectal examination, and no previous biopsy. J Magn
Reson Imaging 2015; 41:1394-1404.
3. Epstein JI, Allsbrook WC, Jr., Amin MB, Egevad LL. The 2005 International
Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading
of Prostatic Carcinoma. Am J Surg Pathol 2005; 29:1228-1242.