Prostate Cancer Detection Rates of Standard Transrectal Prostate Biopsy and MR-guided Fusion Transrectal Prostate Biopsy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Prostate cancer is the most frequent cancer in men. Today serum prostate specific antigen
      (PSA) level and digital rectal examination (DRE) are routinely used for screening of prostate
      cancer. In the case of higher PSA levels and/or abnormal DRE, 10-12 core standard transrectal
      prostate biopsy (STRUS-B) is preferred method.Most of the pathological T1 stage tumours are
      diagnosed by this method. But as the prostate volume increases, cancer detection rate of
      STRUS-B decreases.In the last decade multiparametric prostate magnetic resonance imaging
      (mpMR) has gained importance in the diagnosis of prostate cancer beside the staging. Now it
      is possible to biopsies from lesions which are suspicious for cancer in mpMR. Recent studies
      have shown that mpMR guided prostate biopsies either transrectally or perineally have better
      cancer detection rates comparing STRUS-B, especially in patients with history of negative
      previous biopsy. But its use in biopsy naive settings is not recommended.In this study it is
      aimed to compare cancer detection rate of MR guided MR-US fusion transrectal prostate biopsy
      with STRUS-B.
    

Detailed description: 
      A histopathological evaluation of STRUS-B materials based on suspicious DRE findings and high
      or increasing PSA levels is the gold standard in prostate cancer diagnosis. However, the fact
      that approximately one-third of malignant prostate lesions is isoechoic and cannot be
      detected using conventional grayscale transrectal ultrasonography (TRUS) decreases the
      sensitivity rates of STRUS-B. These restrictions on the use of TRUS have encouraged
      urologists to use new methods to diagnose prostate cancer. One of these methods is the biopsy
      of lesions defined using mpMR, which has been widely used for the past 10 years. An MR
      targeted biopsy can be performed cognitively under MR guidance or using ultrasound devices
      with fusion software that can combine MR images with sonographic images. mpMR targeted
      biopsies are recommended in the current clinical practice for re-biopsies of patients who had
      previous negative biopsy but clinically suspected of cancer, follow-up biopsies of active
      surveillance, and biopsies of patients who are suspected to have recurrence after local
      minimally invasive treatment, such as radiotherapy and high-intensity focused
      ultrasonography. Recent studies showed that the cancer detection rate of mpMRIguided prostate
      biopsy is between 33.7% and 79.5%, which is higher than that of standard 12-core transrectal
      biopsy. However, the number of studies evaluating the use of MR targeted prostate biopsy in
      biopsy naive patients is limited.

      In this study it is aimed to compare cancer detection rates of STRUS-B and MR guided MR-US
      fusion transrectal prostate biopsy in the biopsy naive patient setting.

      100 patients will be randomized to STRUS-B arm and another 100 to fusion arm. In the standard
      arm patients who have high PSA levels and/or suspicious DRE will be undertaken STRUS-B. In
      the study arm all patients will undergo a multiparametric prostate MR without endorectal
      coils. MRI will be performed by Siemens Magnetom(Trade mark) 1.5 T (Siemens Medical
      Solutions, Pennsylvania, USA) MRI system. The images wi,ll be reviewed by an experienced
      uro-radiologist who has no detailed clinical information about the patients. Suspected areas
      in T2, T1 contrast, and diffusion-weighted images of multiparametric MRI were reported
      according to Prostate Imaging Reporting and Data System Version-2 (PIRADS v2). In cases of
      multiple lesions with different PIRADS scores, the lesion with the highest PIRADS score will
      be accepted as dominant lesion. Biopsy procedures will be performed under local anesthesia or
      sedoanalgesia. However, sedoanalgesia will be preferred if the patient could not tolerate
      pain during the penetration of US probe due to low pain threshold or anal canal stricture due
      to previous rectal surgeries. The procedure will be performed in outpatient clinic
      conditions. Transrectal ultrasonography will be performed by using an ultrasonography system
      with rigid fusion software (LOGIQ E9; General Electric, Massachusetts, USA) when patients lie
      on the left decubitus position. Rectal lidocaine gel will be applied 5 min before rectal US
      probe is introduced. A sonographic examination of the prostate tissue will be performed to
      check the presence of prominent lesions. Total prostate volumes will be measured.
      Multiparametric prostate MRI images will be uploaded to the US system on the day of biopsy.
      After segmentation (matching) of MRI images with sonographic images, the lesions reported in
      mpMR will be marked. The periprostatic block will be then performed with 2% prilocaine
      hydrochloride (20 mg/mL) injected into the neurovascular bundle on both sides of the
      prostate, with 5 mL to the right and 5 mL to the left. Following the block, two to five core
      biopsies from the MRI-targeted lesions with PIRADS ≥3 will be obtained. All procedures in
      fusion biopsy will be performed by two urologists experienced and trained in transrectal
      prostate ultrasonography and biopsy. After the F-TRUS biopsy completed, a standard 12-core
      TRUS biopsy will performed on fusion group. STRUS_B arm only standard 12 core transrectal
      prostate biopsy will be performed. A histopathological evaluation of biopsy specimens will be
      performed by a uro-pathologist with >10 years of experience. The percentage of cancer within
      the core, primary, and secondary Gleason score and grade according to the 2014 International
      Society of Urological Pathology (ISUP) grade will be specified in the final pathology report.
      Patients reported with high-grade prostatic intraepithelial neoplasm in three or more cores
      or atypical small acinar proliferation will be redirected to rebiopsy, but they will be
      included to the benign group in the evaluation of the present study.

      As the secondary outcomes, pain level during MR fusion biopsy and STRUS biopsy evaluated by
      visual analogue scale score, cancer detection rates of different core numbers taken form MR
      targeted lesion, role of the peripheric blood parameters (such as, neutrophil to lymphocyte
      ratio and systemic immune inflammatuary index) in predicting prostate cancer in PRIADS 3,4
      and 5lesions, and comparison of the tumor laterality and ISUP grade in MR US fuison biopsy
      and radical prostatectomy specimens will be evaluated.
    

Intervention name(s): mpMR guided MR-US fusion transrectal prostate biopsy; 12 core standard transrectal prostate biopsy
Intervention type(s): Procedure; Procedure
Intervention description(s): mpMR images will be loaded to US fusion platform and registration of the will be performed. Suspicious lesions on MR which have PIRADS score 3 and above are targeted. Additional 2-4 cores biopsies will be taken them; Under the guidance of transrectal ultrasonography, 12 core biopsies taken from apex, apex lateral, mid, mid lateral, base and base lateral of right and left prostate lobe
Other intervention name(s): Fusion biopsy; STRUS-B
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To perform standard transrectal prostate biopsy and MR guided MR-US fusion prostate biopsy in the 2 randomized patient group
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: multiparametric prostate magnetic resonance imaging; MR-US fusion; MR guided prostate biopsy; prostate cancer