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FLAPP: US/MRI Fusion Local Anestesia TransPerineal Prostate Biopsies for Detection of Prostate Cancer

Sponsor
Karolinska Institutet (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04797078
Collaborator
Capio Sankt Görans Hospital (Other), GHP Urologi Odenplan (Other), Urologifocus Stockholm (Other)
800
Enrollment
2
Arms
21.5
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transperineal biopsy
  • Procedure: Transrectal biopsy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Jan 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Transrectal fusion biopsies of the prostate

Transrectal approach, patient in left lateral position, local anestesia 10ml lidocaine 1% at prostate base laterally and apex if indicated. MRI-ultrasound fusion-guided biopsies with 4 biopsy cores per lesion, where clinically indicated. 18G biopsy needle. Standard 12-core template for systematic biopsies. 18G biopsy needle. Antibiotic prophylaxis with 750mg ciprofloxaicin, single dose p.o.

Procedure: Transrectal biopsy
Transrectal MRI-US fusion prostate biopsy
Experimental: Transperineal free hand fusion biopsies of the prostate

Men randomized to the experimental arm undergoes free-hand targeted transperineal fusion biopsies as defined below. Patient is placed supine in the lithotomy-position. The perineal area is prepared with chlorhexidine 0,5ml/ml. 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. Free-hand MRI-ultrasound fusion-guided biopsies with at least 4 biopsy cores per lesion. Coaxial technique with 18G biopsy needle. 10-12 Systematic biopsies according to the modified Barzell 12-core template. No antibiotic profylaxis unless warranted by immunosuppression, previous sepsis or urinary tract infection.

Procedure: Transperineal biopsy
Transperineal free hand MRI-US fusion prostate biopsy

Outcome Measures

Primary Outcome Measures

  1. Rate of prostate cancer detection [Data available at completed inclusion]

    Detection of clinically significant prostate cancer (defined as any ISUP >2). Per PIRADS grade group.

Secondary Outcome Measures

  1. Rate of urinary tract infection and sepsis [Data available at completed inclusion + 30 days]

    Rate of infectious complications (defined as treatment with antibiotics) within 30 days after intervention. Stratified on infections requiring hospitalization.

  2. Individual complications requiring hospital admission. [Data available at completed inclusion + 30 days]

    Any complication after intervention requiring hotspital admission within 30 days

Other Outcome Measures

  1. Patient tolerability [Data available at completed inclusion + 30 days]

    Pain level assessed by visual analogue scale (VAS) Most painful part of procedure Assessed immediately following procedure, and at 30 days

  2. Outcomes after radical prostatectomy [1 yr after study inclusion closes]

    Rate of radical surgery and functional outcomes after radical prostatectomy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Karolinska Institutet
  • Capio Sankt Görans Hospital
  • GHP Urologi Odenplan
  • Urologifocus Stockholm

Investigators

  • Principal Investigator: Tobias Nordström, PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tobias Nordström, MD PhD, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04797078
Other Study ID Numbers:
  • STHLM3FLAPP
First Posted:
Mar 15, 2021
Last Update Posted:
Mar 15, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tobias Nordström, MD PhD, Karolinska Institutet
transperineal biopsy
prostate cancer detection
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Mar 15, 2021