Clinical trial NCT04797078: US/MRI Fusion Local Anestesia TransPerineal Prostate Biopsies for Detection of Prostate Cancer
Official title: Prospective Randomized Controlled Study: Free-Hand Transperineal vs. Transrectal Systematic and Image Fusion Targeted Biopsies Under Local Anesthesia Comparing Rate of Significant Cancer Detection and Complication Rates
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: transperineal biopsy
prostate cancer detection
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Capio Sankt Görans Hospital
name: GHP Urologi Odenplan
name: Urologifocus Stockholm
First posted: 2021-03-15
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Signed written informed consent to participate
* Be aged 18 years and over
* An understanding of the Swedish language sufficient to understand written and verbal information about the trial and consent process
* Be suited and fit for either procedure (transrectal/transperineal)
* Be suitable for a prostate biopsy and clinically due to have a biopsy for diagnostic purpose (following indications for biopsy)

  * Biopsy naïve
  * Men on active surveillance (AS)
  * Rebiopsy
* Be willing and able to comply with scheduled visits and completion of study questionnaires

Exclusion Criteria:

* Severe illness such as metastatic cancers, sever cardio-vascular disease or dementia
* Men with contraindication for a prostate biopsy
* Men without suspect lesions on MRI
* Previous TURP or other BPH treatment (HoLEP, PostaLUND, water-vaporization) is permitted, but men who have had HIFU, cryo, IRE (irreversible electroporation), photodynamic, or microwave therapy to the prostate will not be included.
* Previous treatment with BCG for bladder cancer
* Men who are unable to undergo transrectal ultrasonography
* Men who have had previous radiation therapy to the pelvis
* Men not tolerating ciprofloxacin
* Unable to lie down with legs in a stirrup for at least 45 minutes, as assessed by a clinician

Primary outcomes:
measure: Rate of prostate cancer detection
timeFrame: Data available at completed inclusion
Secondary outcomes:
measure: Rate of urinary tract infection and sepsis
timeFrame: Data available at completed inclusion + 30 days
measure: Individual complications requiring hospital admission.
timeFrame: Data available at completed inclusion + 30 days
Other outcomes:
measure: Patient tolerability
timeFrame: Data available at completed inclusion + 30 days
measure: Outcomes after radical prostatectomy
timeFrame: 1 yr after study inclusion closes
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Tobias Nordström, PhD
role: PRINCIPAL_INVESTIGATOR
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