New Study Finds Freehand Transperineal Biopsies with the PrecisionPoint™ Transperineal Access System Achieve Significant Cancer Detection Rates
A recent study titled ‘Pooled outcomes of performing freehand transperineal prostate biopsy with the PrecisionPoint Transperineal Access System,’ authored by Michael Tzeng, Spyridon P. Basourakos, Hiten D. Patel, Matthew J. Allaway3, Jim C. Hu, Michael A. Gorin, evaluated the cancer detection rates, complications, and tolerability of freehand prostate biopsies performed under local anesthetic using the PrecisionPoint™ Transperineal Access System.
Prostate Biopsy History
In recent years, the limitations of the original freehand technique for performing transperineal prostate biopsy have been overcome following the introduction of a purpose-built, probe-mounted needle guide that includes a common access cannula – known as the PrecisionPoint Transperineal Access System.
Following its approval by the United States Food and Drug Administration (FDA) in 2016, this device facilitated the rapid adoption of transperineal prostate biopsy worldwide, and led to widespread calls for the complete abandonment of the transrectal (TRUS) approach to prostate biopsy – otherwise known as TREXIT.
Historically, the TRUS guided transrectal biopsy was the traditional method of prostate cancer detection, which uses a biopsy needle to puncture the prostate. However, this procedure may cause infection, with high rates of sepsis, as well as inaccurate identification of potential cancer cells.
This report provides the results of a systematic review of the available literature on the outcomes and complications of performing transperineal prostate biopsies using the PrecisionPoint device.
Across the 16 studies included in the analysis of cancer detection rates (CDRs), data was available for 3886 transperineal biopsy procedures, which were all performed with a similar overall technique with only minor variations. The included studies were performed globally – in the United States, the United Kingdom, Asia and Australia.
The analysis of complications included data from 3411 patients across 15 studies. The raw pooled proportions of patients experiencing sepsis, urinary retention, and bleeding requiring medical intervention were 0.1% (4/3411), 1.3% (45/3411) and 0.2% (7/3411), respectively.
Additionally, the subanalysis of biopsy-naïve patients yielded a CDR for clinically significant disease of 54.5%, which remains favourable compared to other biopsy techniques.
The efficacy of PrecisionPoint for detecting anteriorly located tumours was apparent in the analysis. In one study, Chen et al. reported an anterior tumour CDR of 49.5% in biopsy-naïve patients, of which 83.8% were clinically significant. Additionally, Szabo et al. found that 80% of patients with a positive biopsy after a prior negative biopsy procedure harboured cancer in the anterior region only.
Multiple experiences with the PrecisionPoint device have assessed the relative importance of systematic biopsies. In two studies, 12–14% of clinically significant cancers that were missed on targeted biopsy were detected on systematic sampling of the prostate.
Furthermore, the rates of post-procedural complication for transperineal biopsy with the PrecisionPoint device were similar to those reported for other transperineal techniques. Most notably, the pooled rate for post-biopsy sepsis was only 0.1%, which is far lower compared to the transrectal approach.
It was also found that the transperineal approach with the PrecisionPoint device allows for the safe omission of antibiotic prophylaxis, which can further reduce healthcare costs, and potentially aid in preventing the emergence of multidrug-resistant bacteria.
Specifically, out of the 3129 cases in the analysis where antibiotic use was specified, antibiotic prophylaxis was entirely omitted in 1257 (40%) cases, with no observed increase in the rate of infectious complications. This observation is consistent with other reports, regardless of method for performing transperineal prostate biopsy.
The literature consistently demonstrated a benefit in terms of shorter procedure times with the PrecisionPoint device as compared to grid-based techniques.
However, one critique of the analysis is that the advantages associated with use of PrecisionPoint are likely more attributable to the transperineal approach in general, and not use of the device itself.
With that said, within the broad category of freehand techniques for performing transperineal prostate, there is evidence supporting the need for a “device-driven” approach that incorporates a needle guide that is directly coupled to the ultrasound probe. For example, Pramod et al. found that use of a 3D-printed, probe-mounted needle guide resulted in shorter procedural times and improved biopsy accuracy among trainees performing transperineal biopsies in a simulation setting. Moreover, all participants found the device was easy to use and made the procedure easier to perform.
The report concludes that there is uniform evidence supporting the use of the PrecisionPoint Transperineal Access System for performing freehand prostate biopsy procedures. The reported cancer detection and infectious complication rates with this device are in line with other methods for performing transperineal prostate biopsy.
Overall, transperineal biopsies with the PrecisionPoint Transperineal Access System achieved clinically significant cancer detection rates of 67.9% and 42.6% respectively. Complications were rare, with sepsis reported in 0.1% procedures, and patients reported acceptable tolerability of the procedure when performed under local anesthesia. This ability to facilitate performing transperineal prostate biopsies under local anesthesia is a unique aspect of the PrecisionPoint device – and this factor will likely lead to increased adoption of the beneficial transperineal approach to prostate biopsy.