An interventional study of Transperineal biopsy and Transrectal biopsy in Prostate Cancer, sponsored by Karolinska Institutet. Withdrawn. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Diagnostic
We are conducting a randomised trial comparing outcomes of transperineal prostate biopsies under free-hand software assisted MRI/US fusion with transrectal biopsy guide software assisted MRI/US fusion. Primary outcome is the detection of clinically significant prostate cancer. Secondary outcomes is rate of complications including infection and sepsis, as well as feasibility and patient tolerability.
Prostate cancer is a leading cause of cancer death among men in the Western world. Early detection of prostate cancer has been shown to decrease mortality. When a test for prostate cancer yields an elevated risk of prostate cancer, tissue sampling from the prostate is warranted. The common practice is to acquire these biopsies has been via transrectal biopsies under ultrasound guidance (TRUL-biopsies). A low estimate of the risk of hospital-requiring infection is 5%, yielding unnecessary and costly sepsis cases.
In addition to suffering and loss of production, as well as healthcare costs, in a material from Taiwan, the mortality risk of biopsy-induced sepsis has been estimated at 0.13%. In a publication from Norway, it is estimated that infection complications from tissue sampling of the prostate cause 10 deaths per year (population 5 million).
Previous international studies show that the risk of infection with bacteria from the gut can be completely eliminated by taking the tissue samples through the skin of the perineum, transperineal biopsies (TPb), with guidance from transrectal ultrasound. This method is well established for systematic biopsies and has been proven safe in large series.
Studies have showed how multiparametric magnetic-resonance imaging (mpMRI) of the prostate accurately can identify lesions harboring clinically significant prostate cancer (csPC, defined as ISUP Gleason Group (GG) ≥ 2)3. Prostate MRI reading and reporting according to the PI-RADS protocol is widely accepted and recommended.
The image material from the MRI can be used to produce maps of the prostate used for tissue sampling of suspected areas. This is referred to as MRI/ultrasound fusion biopsy, or targeted biopsies (TBx). Regions of interest are marked as Lesions. Several studies have shown improved cancer detection using MRI and fusion targeted biopsies in clinical-practice cohorts 5,6 78 MRI/ultrasound fusion biopsies can be performed in a variety of ways, where software assisted transrectal biopsies has gained the most attention during the last few years, earning to development of equipment more readily available to the urologist as well as a rise in the quantity and quality of prostate MRI's.
The combination of transperineal prostate biopsies and targeted biopsies can be done with a rigid system of stepper and brachy-grid guiding. Recently, several systems for free-hand transperineal biopsies have been introduced, but data and recommendations on biopsy strategies and accuracy is lacking. The detection rates of cancer has not been evaluated in In comparison with transrectal prostate biopsy, transperineal prostate biopsy has the advantage of better sampling from the anterior area of the prostate, an area that is technically more challenging to sample with the transrectal approach. Other advantages of the transperineal route is believed to be the low risk of infection, and no risk ofrectal bleeding. The main challenge associated with the transperineal method is patient discomfort and pain management.
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Be suitable for a prostate biopsy and clinically due to have a biopsy for diagnostic purpose (following indications for biopsy)
Exclusion Criteria:
1. Transrectal approach, patient in left lateral position, local anestesia 10ml lidocaine 1% at prostate base laterally and apex if indicated. 2. MRI-ultrasound fusion-guided biopsies with 4 biopsy cores per lesion, where clinically indicated. 18G biopsy needle. 3. Standard 12-core template for systematic biopsies. 18G biopsy needle. 4. Antibiotic prophylaxis with 750mg ciprofloxaicin, single dose p.o.
Procedure: Transrectal biopsy
Men randomized to the experimental arm undergoes free-hand targeted transperineal fusion biopsies as defined below. 1. Patient is placed supine in the lithotomy-position. The perineal area is prepared with chlorhexidine 0,5ml/ml. 2. Ropivacain 7,5mg/ml is used as an anesthetic agent. Up to 40ml's (equivalent to 300mg) can be used to anestitize the skin, caudal and cranial part of the urogenital diaphragm and periprostatic tissue. 3. Free-hand MRI-ultrasound fusion-guided biopsies with at least 4 biopsy cores per lesion. Coaxial technique with 18G biopsy needle. 4. 10-12 Systematic biopsies according to the modified Barzell 12-core template. 5. No antibiotic profylaxis unless warranted by immunosuppression, previous sepsis or urinary tract infection.
Procedure: Transperineal biopsy
Transperineal free hand MRI-US fusion prostate biopsy
Transrectal MRI-US fusion prostate biopsy
Rate of prostate cancer detection
Detection of clinically significant prostate cancer (defined as any ISUP \>2). Per PIRADS grade group.
Time frame: Data available at completed inclusion
Rate of urinary tract infection and sepsis
Rate of infectious complications (defined as treatment with antibiotics) within 30 days after intervention. Stratified on infections requiring hospitalization.
Time frame: Data available at completed inclusion + 30 days
Individual complications requiring hospital admission.
Any complication after intervention requiring hotspital admission within 30 days
Time frame: Data available at completed inclusion + 30 days
Patient tolerability
* Pain level assessed by visual analogue scale (VAS) * Most painful part of procedure * Assessed immediately following procedure, and at 30 days
Time frame: Data available at completed inclusion + 30 days
Outcomes after radical prostatectomy
Rate of radical surgery and functional outcomes after radical prostatectomy.
Time frame: 1 yr after study inclusion closes
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet