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Exablate MR-guided focused ultrasound launched in US prostate cancer market

February 3, 2022

Urology Times staff

The first commercial patient in the United States has been treated for prostate disease with the Exablate Prostate system, according to Insightec, the developer of the technology.1

The patient received the treatment at Stanford Health Care, which had previously participated in the clinical trials examining the efficacy and safety of Exablate.

The FDA granted Exablate 510K clearance in 2021 for treating prostate tissue with high-intensity magnetic resonance (MR)–guided focused ultrasound (MRgFUS). The 510(k) clearance designation allows a company to market a medical device in the United States if the company can prove that its device is “substantially equivalent” to a device already being legally marketed.2

"We are deeply committed to continuing to transform patient care with minimally invasive, innovative surgical procedures. The Exablate Prostate system will help support a better quality of life for people diagnosed and living with prostate disease," Maurice R. Ferré MD, Insightec CEO and Chairman of the Board of Directors, stated in a news release.

Clinical support

Clinical findings from a phase 2b study (NCT01657942) supporting the use of Exablate MRgFUS in men with intermediate-risk prostate cancer were shared at the 2021 AUA Annual Meeting.3 Overall, the study included 101 men who were treated at 7 academic centers and 1 private practice.

The average patient age was 63 years and 86% of the cohort was White. The median PSA was 5.7 ng/mL. Eighty-four patients had at least clinical stage T1c disease. Seventy-eight percent of patients were in grade group 2 and 22% were in grade group 3.

At 24 months, 88% of men had no evidence of grade group 2 or 3 prostate cancer in the treatment area according to targeted prostate biopsy. Additionally, 60% of men had no evidence of grade group 2 or 3 disease anywhere in the prostate gland, including outside of the treatment area. Serum PSA levels decreased by almost 50% after treatment and stabilized after 6 months.

Erectile function scores were slightly worse at 24 months compared with baseline (HR, -3.5; 95% CI, -5.4 to -1.6). Ten (13%) reported no sexual activity and 81% of patients achieved erections adequate for intercourse. Lower urinary tract symptoms were similar at baseline and 24 months (mean score difference, 1.1; 95% CI, 0.33-1.8).

“Overall, approximately 75% of men were able to achieve functional reactions after treatment at 24 months without starting a new erectile function medication,” Behfar Ehdaie, MD, MS, a urologic surgeon at Memorial Sloan Kettering Cancer Center and Exablate trial PI, said at the time of the AUA presentation of the results. “No patients reported urinary incontinence and the estimated probability of urinary continence over time was excellent.”

References

1. First US commercial patient treated for prostate disease with Insightec incisionless focused ultrasound system. Published online February 3, 2022. Accessed February 3, 2022. https://prn.to/3AV92VY.

2. 510(k) Clearances. US Food and Drug Administration. Accessed August 27, 2021. https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

3. Ehdaie B, Tempany C, Holland F, et al. MRI-guided focused ultrasound (MRgFUS) focal therapy for intermediate-risk prostate cancer: final results of a phase IIb multicenter study. Presented at: 2021 American Urological Association Annual Meeting; September 10-13, 2021; virtual. Abstract LBA02-12.

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Robert Dreicer, MD: I am often asked to sort of speculate where [I think] therapeutic management of mCRPC [metastatic castration-resistant prostate cancer] is going, and I think put simply it’s going to get complicated. It’s already complicated. It’s a very heterogeneous disease; we all understand that, because of the leftward earlier movement of the therapies we used for mCRPC, there are gaps. There are a number of drugs in the pipeline and there are a number of drugs that may see regulatory approval early in 2022, including lutetium177-PSMA-617. There are also PARP [poly adenosine diphosphate-ribose polymerase]/ARI [alpha reductase inhibitor] combinations for which level 1 evidence is forthcoming. We know that certain patients with DDR [DNA damage response and repair] mutations need to be targeted differently at least today, but the potential for “BRCA-ness,” or increasing synthetic lethality with a combination of a PARP and an ARI, may open up a very interesting time frame. There are other PSMA [prostate-specific membrane antigen] therapeutics coming, both in terms of radioactive materials including alpha particles, as well as a whole generation of PSMA-targeted immunomodulatory therapies—CAR [chimeric antigen receptor] Ts, biospecifics, etc. I think what we’re going to increasingly see is the segmentation hopefully based on some biomarker to begin to deliver different sequences to specific groups of patients going forward. We’re not there. We need better therapies, and again, at the end of the day, we’re not curing mCRPC, we need to move to a paradigm where that becomes an option for a subset of patients as these therapies come online.

Transcript edited for clarity.

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Robert Dreicer, MD: Among the drugs that are in trials now, there is a drug that I have been asked about as I have a relationship with the ongoing phase 3 [trial] and that’s sabizabulin, which is an oral cytoskeletal disruptor. It probably disrupts the cytoskeleton in a number of different mechanisms. It’s not taxane; it’s not a taxane-like drug, although it has similar targets. This oral agent has been in phase 1/2 trials. We have data from a phase 1B study that was led by Dr Mark Markowski of Johns Hopkins Hospital [Baltimore, MD] and this data was presented at ASCO [American Society of Clinical Oncology annual meeting] last year and no doubt will likely be updated at coming meetings. What we know about this agent is it’s an oral agent and it’s relatively well tolerated. Its toxicities tend to be GI [gastrointestinal], nausea, and some diarrhea but at the dose being studied in phase 3, it is a relatively well-tolerated therapy. What we've seen so far in this phase 1B study, which was about 30 patients with mCRPC [metastatic castration-resistant prostate cancer] that had progressed on at least 1 ARI [alpha reductase inhibitor] is that there's some evidence of antitumor activity that’s manifested both in seeing some soft tissue responses, some PSA [prostate-specific antigen] declines, and a couple of these patients have been on a drug for a long period of time, more than a year, approaching 2 years. My perspective on this agent is that there’s activity, it strikes me as almost a static agent, again that’s me speaking, that’s not data that we have yet, but in terms of the ability to have a drug on-board and have the ability to alter the natural history. We’re not seeing a dramatic resolution of disease, but we are seeing people who are able to tolerate this agent for prolonged periods of time and have antitumor activity. It’s an interesting compound because of the data seen to date. There is an ongoing phase 3 trial to test this drug further.

Sabizabulin is in a phase 3 trial entitled VERACITY, and this is a relatively small phase 3 trial that is randomizing patients to receive sabizabulin vs the alternative ARI. Eligibility, mCRPC patients who’ve progressed on an ARI, only minimal taxane prior exposure was allowed, so standard therapy in the castrate-sensitive or metastatic CRPC setting is not allowed, so this is really an early study of ARI progressing patients. The primary end point in this trial; radiographic progression-free survival. The eligibility is otherwise relatively straightforward, encompassing the issue of prior treatment. This study is open at a number of sites both in the U.S. and in Europe, and hopefully, it’s going to accrue relatively rapidly and give us an understanding of the utility of sabizabulin in mCRPC.

If sabizabulin happens to demonstrate activity, meaning meeting its primary end point of radiographic progression-free survival, and would eventually receive regulatory approval, this is a drug that you could also perceive to be used relatively early on in the disease course. It’s being tested in patients who have not been particularly heavily treated, these are ARI progressors, and so these patients are not uncommon. It appears to be a relatively well-tolerated drug, given the fact that there are a number of patients in the early phase 1 studies that have tolerated the drug for long periods of time with disease control. You could see this agent being used exactly in the clinical setting in which it’s being tested, as a drug that may provide long-term disease control with a relatively good quality of life. Now, obviously, we’re not there yet. We need to see. We need to finish phase 3, get the data, and then assess the safety, but this is a drug that you could see being used relatively early in the disease course among a number of clinicians—medical oncologists, urologists— who manage advanced disease and that population of clinicians.

Transcript edited for clarity.

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