2022

Industry Perspective: ConfirmMDx and Improving the Identification of Men at Risk for Clinically Significant Prostate Cancer

Industry Perspective: ConfirmMDx and Improving the Identification of Men at Risk for Clinically Significant Prostate Cancer

Posted by | Jun 2022

Wim Van Criekinge, PhD, Professor of Computational Genomics and Bioinformatics at Ghent University in Ghent, Belgium, and Chief Scientific Officer for MDxHealth in Ghent, discusses ConfirmMDx, a test for prostate cancer from MDxHealth which uses tissue from a negative biopsy. He explains that prostate biopsies have a false negative rate of 25% since they only sample a very small percentage of the prostate and can miss the cancer entirely. ConfirmMDx, Dr. Van Criekinge notes, leverages the fact that cancer originates from changes in DNA which create a halo or field effect around the actual tumor. He details the specific ConfirmMDx genes, all of which were previously cited in a prognostic context, and explains that negative cores that are proximal to cancer will show up positive on ConfirmMDx. Dr. Van Criekinge highlights that ConfirmMDx, which has a negative predictive value of 96%, outperforms traditional methods like age, PSA, atypia, and the PCPT Risk Calculator 2.0 in identifying men harboring aggressive cancer. He also emphasizes the test’s accessibility and low cost, noting that the vast majority of patients are responsible for paying $250 or less. Dr. Van Criekinge concludes by detailing the clinical information required for the ConfirmMDx test, including PSA and DRE result, PSA and DRE date, and the pathology report, adding the caveat that tissue more than 30 months old may be rejected.

Read More

MRI-guided Transurethral Ultrasound Ablation (TULSA) for Prostate Cancer

Posted by | Jun 2022

Laurence Klotz, MD, Professor of Surgery at the University of Toronto and the Sunnybrook Chair of Prostate Cancer Research, discusses the technology, procedure, outcomes, and regulatory environment surrounding MRI-guided transurethral ultrasound ablation (TULSA) treatment for patients with prostate cancer. He begins by displaying a chart of multiple minimally invasive treatment options for prostate cancer. Dr. Klotz lists prospective studies of focal therapy that found relatively few adverse quality-of-life (QOL) effects. He goes on to compare five ultrasound-based technologies in terms of biopsy and prostate-specific antigen (PSA) outcome, concluding that data demonstrates these therapies work. Dr. Klotz emphasizes that there is not currently a way to differentiate the oncological efficacy of these treatments, citing the number of variables and reiterating that they all are reasonably effective. Dr. Klotz then turns the discussion to MRI-guided transurethral ultrasound ablation (TULSA), explaining the function of the technology and the system components involved, explaining that the energy delivered is controlled by a closed-loop control system. He outlines the key features of the TULSA system, explaining that it delivers transurethral directional ultrasound ablation which is incision and radiation free, and there is no energy coming through the rectum and there is no volume limitation. Further, real-time MRI thermal dosimetry and ablation control means temperature is measured in real time and the system adjusts the amount of energy delivered to the tissue, providing precision, actively compensating for tissue and blood flow changes during the treatment. Finally, the system offers thermal protection of important anatomy (i.e., urethra and rectum cooling). Dr. Klotz then outlines the evolution of the TULSA technology, including technical studies, canine studies, first-in-man treatment, and feasibility studies. He describes the TULSA-PRO Ablation Clinical Trial (TACT), which involved 115 patients across 13 institutions in five countries, with safety (frequency/severity of adverse events) and efficacy (PSA reduction ≥75 percent in >50 percent of patients) being the primary endpoints at 12 months. Ninety-six percent of patients had a PSA reduction ≥75 percent at 12 months and at the 12-month MRI the median prostate volume had decreased from 41 to 4 cc (a decrease of 90 percent). Further, the treatment preserved continence and erectile function. In a three-year follow-up among men who underwent the treatment, just 11 percent needed salvage treatment. Dr. Klotz explains the challenges involved in demonstrating level-one evidence for the benefit of new technologies since benefits tend to be incremental and gradual. He cites the da Vinci robot as an important example and explains that the U.S. Food and Drug Administration (FDA) has acknowledged this in its approval of high intensity focused ultrasound (HIFU) and TULSA (for tissue ablation). Dr. Klotz concludes with a summary of the TULSA technology, procedure, outcomes, and regulatory considerations, explaining that this new technology is being offered in the US and Europe and is pending in Canada.

Read More

Socioeconomic Aspects of Prostate Brachytherapy

Posted by | Jun 2022

As part of a special course on brachytherapy for prostate cancer from the American Brachytherapy Society (ABS) and Grand Rounds in Urology, Peter F. Orio III, DO, MS, Vice Chair of Network Operations for Dana-Farber/Brigham and Women’s Cancer Center Department of Radiation Oncology and Associate Professor of Radiation Oncology at Harvard Medical School in Boston, Massachusetts, discusses socioeconomic influences on the use of prostate brachytherapy. He begins by listing nine factors that he believes have led to a decline in the use of prostate brachytherapy: (1) a decrease in PSA screening and prostate cancer diagnosis; (2) an increase in patients electing active surveillance; (3) Nuclear Regulatory Commission requirements; (4) an increase in the number of robotic prostatectomies; (5) a suboptimal volume of prostate brachytherapy procedures being performed; (6) negative press about brachytherapy from procedures performed at the Philadelphia VA; (7) the increased technical sophistication of external beam radiation technologies; (8) a lack of knowledge of brachytherapy’s efficacy; and, most significantly, (9) markedly decreased reimbursement rates for brachytherapy. Focusing on this last point, Dr. Orio considers a report by the Government Accountability Office which found that if there was a self-referring interest in a center that offered intensity-modulated radiation therapy (IMRT), use of IMRT would increase by about 50%, while radical prostatectomies would decrease by 27% and brachytherapy procedures would decrease by 50%. He explains that in a fee-for-service model, a treatment like brachytherapy which requires one implant is reimbursed for far less than a treatment like IMRT which requires weeks of treatment over the course of multiple sessions. This creates, Dr. Orio argues, a disincentive to perform brachytherapy even though it is less expensive and results in better quality of life than IMRT. He suggests that implementation of the radiation oncology alternative payment model (RO-APM) may solve this problem. Dr. Orio explains that the RO-APM, which is being tested in certain zip codes, represents a shift to value-based care and is intended to simplify coding and reduce Medicare costs. Under the RO-APM, he notes, regardless of the modality of treatment, the payment is the same, so brachytherapy monotherapy will likely benefit from an increase in payment. Dr. Orio concludes that the RO-APM may lead to a resurgence in prostate brachytherapy by removing financial disincentives to performing the procedure.

Read More