Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Infective Agents

All Drugs and Chemicals

Formaldehyde

all biopsy cores were handled using the Smartbx™ system. part of the procedures were performed with both Navigo™ and Smartbx™ system.

all biopsy cores were handled using standard method - shaking the biopsy needle into formalin vial. no navigation system.

The SmartBx™ system semi-automated downloads the biopsy cores from the biopsy needle onto a designated cassette which integrates into the routine pathology lab processing. The core is downloaded in an oriented and straightened fashion while preserving core fragments in its original locations relative to the needle notch.

Smartbx™ system.

Ofer Nativ, Prof.

he most common method for performing a prostate biopsy procedure is the ultrasound guided transrectal procedure. The information obtained from the standard prostate biopsy is deficient and even misleading. Cancers can be missed on initial and even in repeated biopsy. Moreover, the detection of a tumor cannot predict accurately the tumor size and location1. It was proven that the exact location of the obtained cores, even in an initial biopsy, can influence the cancer detection rate2.

An imaging tool that will enable a three-dimensional navigation in the prostate volume and selecting biopsy locations in view of previous core taken will allow building a "tumor map" '(i.e. detecting tumor size and location). By mapping the prostate cancer an adequate treatment can be chosen while avoiding over or insufficient treatment.

However, to be able to produce an accurate mapping of the malignant tissue, a complementary optimized pathology method should be also implement in addition to the navigation system, it has been shown that a pre-embedding procedure that keeps the specimen orientation, unfolding, unity, and location along the needle notch improves the histological yield and hence the cancer detection rate3.

The NaviGo™ Workstation (hereafter the NaviGo™ Workstation or the NaviGo™ System) allows physicians to see the prostate gland together with the biopsy sites in a three dimensional (3D) view, modeled from two dimensional (2D) images. The NaviGo™ Workstation was designed as an adjunct to standard of care procedures, to work with standard rectal ultrasound probes, and to be incorporated side by side with the techniques currently employed. No change to the current employed procedures and techniques is required or suggested. In complementary to the Navigo system a system for semi-automatic download of prostate biopsy cores which keeps the orientation, unfolding and unity of the sample was developed to increase the pathology utility.

The study objective is to evaluate the contribution of the Navigo™ system, an aiding navigation tool for TRUS prostate biopsy, to an increase in the prostate cancer detection ability.

Introduction Prostate biopsy is a procedure in which small samples are removed from a man's prostate gland to be later tested for the presence of cancer. It is typically performed when the scores from a PSA blood test rise to a level that is associated with the possible presence of prostate cancer.

The most common method for performing a prostate biopsy procedure is the ultrasound guided transrectal procedure. The information obtained from the standard prostate biopsy is deficient and even misleading. Cancers can be missed on initial and even in repeated biopsy. Moreover, the detection of a tumor cannot predict accurately the tumor size and location1. It was proven that the exact location of the obtained cores, even in an initial biopsy, can influence the cancer detection rate2.

An imaging tool that will enable a three-dimensional navigation in the prostate volume and selecting biopsy locations in view of previous core taken will allow building a "tumor map" '(i.e. detecting tumor size and location). By mapping the prostate cancer an adequate treatment can be chosen while avoiding over or insufficient treatment.

However, to be able to produce an accurate mapping of the malignant tissue, a complementary optimized pathology method should be also implement in addition to the navigation system, it has been shown that a pre-embedding procedure that keeps the specimen orientation, unfolding, unity, and location along the needle notch improves the histological yield and hence the cancer detection rate3.

The NaviGo™ Workstation (hereafter the NaviGo™ Workstation or the NaviGo™ System) allows physicians to see the prostate gland together with the biopsy sites in a three dimensional (3D) view, modeled from two dimensional (2D) images. The NaviGo™ Workstation was designed as an adjunct to standard of care procedures, to work with standard rectal ultrasound probes, and to be incorporated side by side with the techniques currently employed. No change to the current employed procedures and techniques is required or suggested. In complementary to the Navigo system a system for semi-automatic download of prostate biopsy cores which keeps the orientation, unfolding and unity of the sample was developed to increase the pathology utility.

OBJECTIVE AND RATIONALE Study objective Evaluate the contribution of the Navigo™ system, an aiding navigation tool for TRUS prostate biopsy, to increase the prostate cancer detection ability.

Rationale

The Navigo™ system is a noninvasive navigation tool that produces on line 3D model of the prostate that assist the physician to navigate in the prostate volume during the biopsy procedure without changing the imaging system or the biopsy routine whatsoever. The ability to create a 3D model of the prostate and accurately and evenly position the biopsy needle will enable a more accurate biopsy and better analysis of the procedure and the pathological results, hence it might improve the clinical outcomes and may lead to new treatments/diagnostic strategies.

DEVICE DESCRIPTION AND INTENDED USE

The NaviGo workstation is used as an adjunct to the ultrasound imaging and biopsy procedures of the prostate gland. When operated in conjunction with the standard equipment in a TRUS guided prostate biopsy procedure, the NaviGo™ software may be used for the following:

* To assist the physician by transfer and display of ultrasound images on the workstation screen;
* Build display and manipulate a 3D model of the prostate on screen;
* Archiving the ultrasound images and the 3D model;
* Providing data management solutions;
* Tracking, displaying and recording of the biopsy needle trajectory location in real time.

The NaviGo™ Workstation is designed to work with standard transrectal ultrasound system without changing or interfering with the physician's flow of work. The ultrasound images are displayed on the ultrasound system, and the information provided by the NaviGo provides supplementary information to the physician during the procedure. The NaviGo™ Workstation connects to the video output of the ultrasound system and tracks the ultrasound probe's position using an off-the-shelf electromagnetic tracking system consisting of two sensors, one on the ultrasound probe (at the base/ non invasive part of the probe) and the other on the patient's back, a transmitter placed beneath the patient mattress, a processing unit, a laptop computer and the workstation screen. Figure 1 below presents a general view of the NaviGo™ Workstation.

The NaviGo™ system is an aiding tool in the management of prostate biopsy procedure. The NaviGo™ system allows prostate biopsy tracking, recording, and management solution. The NaviGo™ system is designed to assist the physician in performing prostate biopsy procedures by displaying a 3D model with real-time tracking and recording of the biopsy needle location. The device includes means to compensate for patient body and prostate motion at any time during the procedure. The 3D model can be rotated, manipulated and displayed in the physician's preferable choice.

The Navigo™ system is intended to record and display in 3D the biopsy procedure of any patient undergoing a prostate trans-rectal biopsy. The Navigo™ system is intended to record all the data from the initial scan, the volume measurements, and the biopsy needle insertion. All the images are saved and can be reviewed in post analysis, the needle location can be updated according to the physician's marking on the recorded ultrasound image and the pathology results will be displayed in color on the 3D model.

In post procedure, the physician defines the boundaries of the prostate on selected ultrasound images and a 3D model of the prostate is displayed with all recorded biopsy specimens' locations displayed in the prostatic volume. The physician will be able to examine in post analysis the scattering quality of the biopsy specimens in the prostatic volume and update the pathology results.

Summary of features/capabilities incorporated in the NaviGo™ Workstation.

1. Patient data management (recording, retrieval, off-line analyses and addition of biopsy results).
2. Contour-based 3D model of the prostate (surface rendering).
3. Real-time tracking of the needle trajectory - the trajectory is displayed on the 3D model.
4. Recording of biopsy locations - using operator supplied information regarding where biopsies were obtained, a 20mm long mark is provided on the bottom part of the 3D model (where the trajectory crossed the 3D model), with each mark numbered and linked to the relevant saved US image.
5. Prostate volume calculation and measurement - a 3D model is displayed with volume calculation, and 2D measurement capabilities (point to point inside the model) are available.
6. Off line procedure planning - on the previous acquired 3D model with the updated pathology results the physician can schematically place future biopsy locations.
7. Pathology results management and display - update of the pathology results to the 3D model and a color display according to the severity of the results.
8. Procedure report - automatically generated by the end of each procedure in an HTML format. The report can also be saved to an external memory device or viewed at a later time.

METHODS AND PROCEDURES Study Design

1. The study is an open prospective study.
2. The trans-rectal ultrasound guided prostate biopsy procedure will be conducted according to the standard 12 biopsy scheme.
3. In addition to normal procedure set up, there will be Electromagnetic flat transmitter under the patient's mattress, 2 externally attached sensors and the Navigo™ system stand including a laptop computer and the workstation screen (detailed in appendix A - User's Manual).
4. Following the initial prostate scanning and the standard volume measurements done by the physician, a 3D on-line model will be produced as supplementary information to the B-mode standard image. The physician will navigate and determine the biopsy position using the standard B-mode ultrasound image and the 3D prostate on- line model, both shown on the working station screen.
5. The biopsy samples obtained will be placed straightened in a designated pathology cassette or a kit for the orienting of biopsies, constituted from nitrate cellulose filtering membranes. (See appendix B, C).
6. Patient details, core locations in the prostate volume are saved for future analysis and planning.
7. The data obtained in these experiments will be compared to a retrospective data from a comparable cohort of patients who went through standard procedures with the same biopsy scheme. (The control cohort will be chosen to have similar patient's characteristics- age, PSA level).

End points

* Cancer detection rate (via pathology) compared with a control group- standard 12 biopsy from retrospective data.
* Analysis of positive cores distribution in the prostate volume.
* Detection rate vs. PSA level.

SUBJECT RECRUITMENT

Study population will be recruited from the pool of patients who are scheduled for standard trans-rectal biopsy procedure

POTENTIAL BENEFITS TO THE PATIENTS

The Navigo™ system is a navigation aiding tool which assists the physician to navigate in the prostate volume. The physician can locate the biopsy core according to the desired biopsy scheme. The physician can see on-line the location of the previous cores obtained, and thus gaining the advisable dispersing of the cores and avoiding an overlap between adjacent cores. Core positions are saved for post procedure analysis and future planning. Therefore the patient can gain from an accurate positioning of the biopsy cores, which may increase the cancer detection rate in the current biopsy and produce baseline information for future procedures.

POTENTIAL RISKS TO THE PATIENTS

The Navigo™ system is an aiding tool that does not require any change in the procedure performed today and doesn't come instead of the B-mode ultrasound, but works in parallel to it, to add 3D information. The various components do not come in direct contact with the patient or the physician and the computer and 3D tracking system are well within the required safety protocols. Hence, there is no risk to the patients.

The 3D tracking system is approved by the FDA for medical use and is classified as Type CF which is the most stringent classification, being required for those applications where the applied part is in direct conductive contact with the heart or other applications as considered necessary. The 3D tracking system is also part of an approved Helsinki trial in Bnei-Zion hospital (monitoring of the birth progress, trial initiated by Dr. Yoav Paltieli) Adverse effects, any pain or discomfort to the patients are not expected according to the accumulated experience gained in a series of preliminary experiments preformed on 30 patients with the Navigo™ system in Bnei-Zion as part of a Helsinki trail (0101-10-BNZ). The system is also approved to be used in Haemek medical center (Helsinki number, 0018-11) and Meir medical center (?). Therefore, in view of the above mentioned information there is no risk to the patients and to the users.

A Novel 3D Navigation Technology for Improved TRUS Prostate Biopsy

A 3D Navigation Technology for Improved TRUS Prostate Biopsy

prostate cancer detection rate would be compared to that of a retrospetive cohort of patients who underwent prostate biopsy without the Navigo device.

UC Care, Ltd.

Symptoms and General Pathology

Prostatic Hyperplasia

Hyperplasia

Central Nervous System Depressants

Anesthetics

The biopsy needed is inserted to the prostate through the perineal skin, with the assistance of an access system device known as PrecisionPoint. It utilises a single access needle cannula mounted directly on to the ultrasound probe, which acts as an access point traversing through the perineal skin. 4 - 5 cores are obtained from the anterior, mid and posterior zone of each side of the prostate.

The biopsy needle penetrates through the bowel (rectum) to the prostate to obtain 12 cores of prostate tissues from the lateral and medial base, midzone and apex of each side of the prostate (1 core each).

Samples of tissue are removed from the prostate for histopathological diagnosis of prostate cancer through the use of a needle with the assistance of transrectal ultrasound.

Prostate Biopsy

Research Assistant

Wayne Lam, MBBS(Lond)

Wayne Lam

Tranperineal prostate biopsy(TPB) and Transrectal prostate biopsy(TRUSB) are now both routine diagnosis methods of prostate cancer in Queen Mary Hospital. The TRUSB has been the most common way to sample prostate tissue for decades. The TPB has been employed as one of our routine diagnosis methods in early 2018. The aim of this study is to evaluate whether Tranperineal prostate biopsy using a noval transperineal access system under local anaesthesia is non-inferior to standard 12-cores Transrectal prostate biopsy in detecting prostate cancer (PCa), in patients with clinical suspicion of PCa with no prior prostate biopsy.

The incidence of prostate cancer (PCa) has increased considerably in recent years \[1, 2\]. The reported lifetime risk for men in Hong Kong to be diagnosed with PCa is 1 in 31 before the age of 75, and is currently the third commonest cancer Hong Kong men according to the Hong Kong Cancer Registry \[3\]. This highlights the importance of thorough and fundamentally a safe investigation technique to correctly identify patients with PCa. Such test should be able to sensitively detect PCa, and provide early diagnosis. Critically, such test is required to provide accurate disease risk stratification, which is absolutely crucial in guiding level of appropriate treatment is necessary in patients diagnosed with PCa.

According to recommendations from the National Institute for Health and Care Excellence (NICE) guidelines, current standard clinical practice considers histological diagnosis of PCa a necessity in majority of patients presented with localized disease who are eligible for treatment \[4\]. This, alongside with prostate specific antigen (PSA) level, digital rectal examination (DRE) findings, and increasingly the use of multi-parametric MRI (mpMRI) imaging, collectively allows risk stratification of PCa.

The current pathway to obtain prostate tissue for histological diagnosis of CaP is by transrectal ultrasound-guided systematic biopsy (TRUSB) of the prostate, usually following the detection of a raised serum PSA level and/or suspicious rectal examination findings. TRUSB has been the standard prostate tissue sampling technique for men suspected with PCa for over 30 years. It is an office-based procedure carried out under local anaesthesia (LA), with 10 to 12 biopsy cores directed towards the lateral peripheral zones of the prostate thought to harbour majority of cancers \[7\]. However, there are still various well-known cancer detection limitations and patient safety problems associated with TRUSB.

Firstly, a very significant portion of tumours are being missed with the TRUSB technique \[8\]. It has been well- known that over 30% of patients with low risk PCa on TRUSB have been found to harbour clinically significant PCa \[9\]. Many of these tumours missed on TRUSB are located in the anterior and apical regions of the prostate, which TRUSB is difficult to access, in particular in patients with a large prostate volume

Secondly, TRUSB requires the biopsy needle to penetrate through the bowel (rectum). This results in high risk of developing sepsis following biopsy, despite all patients undergoing the procedure being started on antibiotics prophylactically. This is a serious complication which can potentially be life-threatening. Our previous study has already demonstrated a high prevalence of fluoroquinolone-resistant and ESBL-producing rectal flora in our local population in Hong Kong \[10\]. The risk of developing post-biopsy sepsis in Hong Kong is high.

Transperineal prostate biopsy (TPB) has been developed to provide a more comprehensive biopsy method to improve cancer detection rate by directing biopsy cores through the perineal skin. Theoretically, TPB enables access to sample the entire prostate, in particular the anterior and apical regions which are not easily accessible through the standard TRUSB method. By sampling the prostate using biopsy needles directly inserted through the perineal skin rather than bowel, the risk of sepsis is reduced. However, this technique requires multiple needles traversing through the perineum, and requires to be carried out under general anaesthesia (GA). Another disadvantage is a stabilising stepping unit is required to provide a consistent alignment of the ultrasound probe against the prostate in order to carry out the biopsies. Such stabilising stepping units are costly.

A novel but simple transperineal access system device known as PrecisionPoint (Perineologic, Cumberland, MD, USA) has been developed to tackle the aforementioned limitations of TPB. This revolutionary device utilises a single access needle cannula mounted directly on to the ultrasound probe, which acts as an access point traversing through the perineal skin. This design minimises the number of needle punctures through the skin, enabling TPB to be carried out under LA. A stabilising stepping unit is not required with this technique. The device has gained the United States Food and Drug Administration (FDA) approval \[11\], and results from small contemporary series have already been published with very promising results in terms of cancer detection rate and safety \[12\].

TRUSB has a poor cancer detection rate and is associated with potentially fatal septic risk. TPB, if able to be carried out under LA as an office-based procedure, can potentially provide a better cancer detection rate with significantly reduced sepsis risk. It has fundamentally a very high potential to become the new gold standard in obtaining prostate tissue for histological diagnosis of PCa.

With an increasing number of men in Hong Kong with elevated serum PSA suspicion of PCa needing prostate biopsy, it is fundamental to carry out a study to determine the most effective, safe and tolerable prostate biopsy technique which fits with the clinical practice in Hong Kong.

Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men

Randomized-controlled Trial: Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men

Absolute differences in PCa detection rate will be calculated with 95% CIs. If lower bound of 97.5% CI for the difference in cancer detection rates of LA TP biopsy compared with TRUS biopsy is greater than -5%, then TP biopsy will be deemed non-inferior. If lower bound is greater than 0, TP will be deemed superior.

The pain score of the procedure reported by patient

International Prostate Symptom Score (I-PSS)

International Index of Erectile Function (IIEF)

Ca Prostate with Gleason score larger or equal to 3+4

Time from start of ultrasound probe insertion to probe removal

The cost of each diagnosis based on the equipment, manpower and medication

The University of Hong Kong

Clinical Assistant Professor

target prostate biopsies by cognitive fusion

cognitive vs software

Ana Celma, MD

Ignasi Gallardo, Ph

This study evaluates the efficacy to diagnose significant prostate cancer in patients with suspicious lesions in mpMRI (multiparametric magnetic resonance imaging) by comparing prostate biopsies performed by cognitive fusion with respect to those performed with software fusion (BK-fusion®). Half of the patients included will undergo a systematic prostate biopsy + target biopsies by cognitive fusion and the other half of the population, will undergo a systematic prostate biopsy + target biopsies by software fusion.

Various techniques have been developed to perform targeted prostate biopsies aimed at suspicious lesions detected in mpMRI. The two most frequently used are cognitive fusion, in which the physician locates the areas where the mpMRI detects suspicious lesions and directs the puncture by ultrasound; and software fusion, in which the images of the mpMRI are integrated by a software with the ultrasound allowing to direct the puncture to the lesion itself. Both forms of fusion biopsy have proven to be superior to systematized prostate biopsies in the detection of significant prostate cancer, although neither has demonstrated superiority over the other.

Comparison of Prostate Fusion Biopsies With Software and Cognitive

Prospective and Randomized Study to Compare the Efficacy of Cognitive Fusion Prostate Biopsies and Prostate Biopsies Performed by "BK-fusion®" Software, for the Diagnosis of Significant Prostate Cancer

Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed.

Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the location of the lesions.

Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the size of the lesions.

Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the PIRADS (prostate imaging and reporting and data System) of the lesions.

Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the prostate volume.

Hospital Universitari Vall d'Hebron Research Institute

TRUS and TRUS-Robot will be used during prostate biopsy

Just Uronav will be used during prostate biopsy

A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.

TRUS-Robot

TRUS biopsy

Misop Han, M.D., M.S.

Dan Stoianovici, PhD

Misop Han, M.D.

Prostate cancer (PCa) is the most common non-dermatologic malignancy in U.S. men. Transrectal ultrasound (TRUS)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (PSA) level and/or abnormal digital rectal examination (DRE). It is estimated that more than 1 million TRUS-guided prostate biopsies are performed annually in the U.S. alone. However, a freehand TRUS-guided systematic biopsy (SB) procedure has significant limitations. First, freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. Second, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Targeted biopsy (TB) using special devices emerged to help the physicians guide the biopsy using multiparametric MRI (mpMRI). TB cores yield a higher cancer detection rate of clinically significance PCa than SB cores, but TB cores also miss a large number of clinically significant PCa that are detected by SB. Accordingly, TB is commonly performed concurrently with SB (TB+SB procedure).

This study attempts to improve TRUS-guided prostate biopsy by utilizing assistance from a novel robotic TRUS manipulator (TRUS-Robot) developed by our team. The hypothesis of the study is that clinically significant prostate cancer detection rate from the SB cores (at SB or TB+SB) can be improved above that of current devices. The objective of the study is to gain early evidence on the effectiveness of prostate biopsy assisted by the TRUS-Robot vs. a current TB device in a randomized clinical trial.

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Number of biopsy patients diagnosed with Gleason score \>= 7 over the total number of patients on both arms of the study.

Serious adverse events will be assessed according to 21 Code of Federal Regulations (CFR) Part 812.3(s).

Number of biopsy patients diagnosed with Gleason score \<= 6 over the total number of patients on both arms of the study.

Needle targeting errors will be measured as the distance between the planned core center and the inserted needle axis. Targeting accuracy will be calculated as the average of the needle targeting errors, as usual.

The time of the actual biopsy procedure measured in minutes.

Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate sensitivity.

Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate specificity.

Compare biopsy pathology results with gold standard pathology on the subset of patients who follow on to radical prostatectomy. Perform binary tests (True/False x Positive/Negative) and calculate predictive rates.

National Institutes of Health (NIH)

Johns Hopkins University

Anti-Arrhythmia Agents

Channel Blockers

Dermatologic Agents

Lidocaine

Anti-Bacterial Agents

Chlorhexidine

Chlorhexidine gluconate

Antibiotics, Antitubercular

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.

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.

Transperineal free hand MRI-US fusion prostate biopsy

Transperineal biopsy

Transrectal MRI-US fusion prostate biopsy

Transrectal biopsy

Tobias Nordström, PhD

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.

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

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

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

Rate of radical surgery and functional outcomes after radical prostatectomy.

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

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

Any complication after intervention requiring hotspital admission within 30 days

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Novel 3D Navigation Technology for Improved TRUS Prostate Biopsy	NCT01480375	Prostate Cancer	Smartbx™ system...	18 Years -	UC Care, Ltd.
Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men	NCT04108871	Prostate Cancer Prostatic Hyper...	Prostate Biopsy	40 Years - 80 Years	The University of Hong Kong
Comparison of Prostate Fusion Biopsies With Software and Cognitive	NCT04291742	Prostate Cancer... Fusion Prostate...	cognitive vs so...	40 Years -	Hospital Universitari Vall d'Hebron Research Institute
Transrectal Ultrasound Robot-Assisted Prostate Biopsy	NCT02871726	Prostate Cancer	TRUS-Robot TRUS biopsy	45 Years - 75 Years	Johns Hopkins University
A Novel 3D Navigation Technology for Improved TRUS Prostate Biopsy	NCT01480375	Prostate Cancer	Smartbx™ system...	18 Years -	UC Care, Ltd.
US/MRI Fusion Local Anestesia TransPerineal Prostate Biopsies for Detection of Prostate Cancer	NCT04797078	Prostate Cancer	Transperineal b... Transrectal bio...	18 Years -	Karolinska Institutet

Spots Global Cancer Trial Database for prostate cancer detection