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Prostate Cancer (PCa) is the most common male cancer in Denmark and the number is increasing. Annually, about 1,600 men are referred to the Department of Urology, Herlev Gentofte Hospital, due to elevated PSA (Prostate Specific Antigen) or clinical symptoms suspicious of PCa. In approximately 50% of these patients, PCa is diagnosed based on histopathological findings in tissue obtained from transrectal ultrasound biopsy (TRUS-bx). The TRUS-bx is taken from 10 standard zones in the prostate. If PCa lesions are visualized on TRUS, they should appear hypo-echoic compared to the normal peripheral zone. But more than 40-50% of the cancerous lesions are iso-echoic and thus difficult to identify. Furthermore, benign prostate hyperplasia (BPH) in the transitional zone makes it difficult to locate tumours. Therefore, there is a risk of missing a significant cancer or an incorrect grading of the tumors aggressiveness (Gleason score) by TRUS-bx. Thus, 10 systematic biopsies are not always representative of the whole gland. In addition, many men only harbour small in-significant cancer foci, that will never cause patient morbidity or mortality. It is often best not to detect these small insignificant tumour foci due to the risk of overtreatment.
If MRI was performed before any decision to biopsy was made, some patients might not be diagnosed with insignificant PCa since MRI mainly finds significant cancers. The Multiparametric Magnetic Resonance Imaging (mp-MRI) seems to be more accurate in detection and localization of PCa according to clinical studies and several studies have shown that mp-MRI is able to distinguish between patients with significant and insignificant PCa. As mp-MRI visualizes the whole gland it can identify suspicious cancerous regions and be used as a guide for targeted biopsies. Also, this has the potential to decrease the number of biopsies as the 10 standard biopsies can be replaced by 1-4 MRI targeted biopsies. Furthermore, some patients might not need biopsies at all if the MRI does not show any suspect foci, thereby decreasing the risk of complications from the biopsy-procedure.
In theory mp-MRI could be used to determine which patients need to be biopsied and which do not - a sort of screening tool. The current standard examination takes about 45-60 minutes. This is too long and too costly for a screening procedure. Based on the investigators three year long experience, they have chosen two scanning sequences and one calculated sequence, which they believe can answer the question: Is significant cancer present or not? This is the biparametric-MRI (bp-MRI) which takes only 20-25 minutes and does not involve administrating any MRI standard drugs. The chosen sequences are: T2-weighted (T2W) images in the axial plane, diffusion weighted (DWI) axial images with multiple b-values and calculation of the apparent diffusion coefficient (ADC)-map. If, on the other hand, if MRI is to be used for staging purpose, six sequences are needed: T2W images in 3 planes (axial, coronal and sagittal), DWI axial images with multiple b-values plus calculation of apparent diffusion coefficient (ADC)-map and Dynamic Contrast Enhancement (DCE) T1-weighted (T1W). This is called a multiparametric MRI (mp-MRI).
The two T2W sequences in the coronal and sagittal planes can be left out because they mainly add information for staging purposes. The hypothesis is that these two are not necessary, as the investigators only want to determine whether there is sign of significant cancer or not. Neither is the DCE using contrast medium necessary because it only indicates whether post-biopsy-blood is present or not which is not the case in this patient group. The bp-MRI will be less detailed, but most details are not important when using MRI for PCa detection only. Studies show that the ADC-map calculated from DWI correlates with the Gleason score and may be used as a non-invasive measure for cancer aggressiveness.
In summary, the bp-MRI is designed only to determine whether significant cancer is present or not, and will not be able to assess the stage of the cancer (extension through the capsule or invasion into the vesiculae seminalis or urethra/bladder neck). As previously stated, half of the patients that are referred due to suspicion of PCa do not have PCa and there is no need for them to undergo the normal mp-MRI scan. In case of a high-risk patient (>cT2b, Gleason score >7 and PSA >20 (group 2)) staging is necessary and because of that a normal mp-MRI will be performed.
Purpose To study whether a simple non-contrast enhanced bp-MRI of the prostate lasting 20-25 min. can identify significant cancer.
Trial subjects Annually, 1,600 males suspected of having PCa are referred to the Department of Urology at Herlev Gentofte Hospital. They will all be invited to undergo a short bp-MRI if they fulfil the inclusion criteria.
Study Design A prospective observational study where subjects are offered to undergo a short bp-MRI of their prostate before biopsy. At referral the patient receives a letter and an appointment for a consultation with the urologists and a nurse. This is the current standard for all patients. The patient is interviewed for the patient record followed by a physical examination including a DRE. If there is persistent suspicion of PCa the patients will be invited to participate in the study: the patients (group 1) will receive information about the project, an informed consent form and an appointment for the bp-MRI. The patients are given 24+ hours to consider their participation in the study. If they decide to participate they must sign the consent form before the bp-MRI. The form is to be handed over to the radiographer when they arrive at the bp-MRI. If the patient does not want to participate in the study, the bp-MRI appointment will be cancelled. If the surgeon suspects a high-risk cancer (group 2), the patient is referred for a mp-MRI (standard procedure today); the patient is asked if he allows inclusion of the mp-MRI in this study . All patients in this protocol will undergo the current standard 10 biopsies plus one or two biopsies from any significant lesion diagnosed at bp-MRI or mp-MRI. The enrolled patients will be followed for 4 years for diagnosis of cancer or not, treatment recurrence, metastasis and PSA-level.
After the scans are done the further work will be investigations of the:
Correlation between bp-MRI/mp-MRI and histopathology Correlation between bp-MRI/mp-MRI and clinical outcome after 1 year Correlation between bp-MRI/mp-MRI and clinical outcome after 5 years
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Biparametric MRI before biopsy
Not yet recruiting
Published on BioPortfolio: 2015-10-23T14:08:22-0400
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