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Clinical Laserthermia Systems – Prostatacancer och Focal Laser Ablation (FLA)

"Successful completion of the project would lead to a safe, effective, economical system for clinic-based treatment of prostate cancer with minimal side effects available to tens of thousands of men every year, said Marks."

Behandlingsdata presenteras, fakta läggs på bordet och i rampljuset finns Clinical Laserthermia Systems med marknadens bästa medicinska laserfiber. I dagarna har CLS ställt ut på ”10th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer” i Nederländerna. Här har CLS själva även presenterat en poster som i detalj beskriver produkternas egenskaper för FLA behandling. På samma event har även CLS konsulten tillika FLA pionjären Dr. Eric Walser presenterat statistiska data tillhörande FLA behandlingar utav 120 patienter. Eventet kan anses högt prioriterat utav CLS då säljteamet från USA flögs in och flera utav bolagets representanter fanns på plats tillsammans med befintliga såväl som potentiella kunder.

Nedan följer några utdrag från posters utav två av CLS kunder närmare sagt, UTMB och Desert Medical Imaging. Vidare har så klart även CLS egna poster lyfts fram. Värt att notera är att Eric Walser har som bekant tidigare använt sig utav utrustning från Medtronic ägda Visualase, de 120 patienter som behandlats och redovisas har också behandlats med denna utrustning, dock är det så att idag har E. Walser valt att gå över till CLS produkter då dessa enligt honom är vida överlägsna Visualase´s vattenkylda system.

“Focal Laser Ablation of Prostate Cancer: Results in 120 Patients with Low to Intermediate Risk Disease“

Purpose:  Focal laser ablation (FLA)is an alternative treatment for localized prostate cancerWe report the morbidity and oncologic and functional outcomes in the largest FLA series to date.

Materials and methods: 120 patients with low to intermediate risk prostate cancer had transrectal FLA done with a laser fiber inserted into the prostate. MRI thermometry controlled the ablation. Procedures were performed between 2013 and 2016. At 6 and 12 months, patients had clinical and MRI follow-up and with biopsies of suspicious areas and submitted surveys of sexual and urinary function. Multivariate logistic regression dentified determinants of positive imaging and biopsies. Two-sided Wilcoxon signed rank test evaluated scores and lab values.

Results: The median age was 64 and median PSA was 6.05 ng/mL. The mean follow up period was 34 months (from 17 to 55 months). Gleason score was 3+3 in 37 (30.8%), 3+4 in 56 (46.7%), and 4+3 in 27 (22.5%). Twenty (17%) of men had additional oncologic therapy one year after FLA when biopsy confirmed cancer after an abnormal MRI. There was no difference between functional scores pre- and post-ablation.. The median PSA fell to 3.25 at 12 months (p<0.001). Lesion diameter above the median (Odds Ratio (OR), 3.36; 95% CI, 1.41-7.97) was the only significant predictor for a positive post-treatment MRI..

Conclusions: At 1 year, FLA in selected patients has low morbidity, no significant changes in quality of life and 83% freedom of retreatment rate. Sexual and urinary function did not change after FLA. ”

http://epo.epostersonline.net/focal2018/node/383

Ytterligare en poster som presenterats på eventet där E.W är delaktig.

http://epo.epostersonline.net/focal2018/node/392?view=true

“A phase II study to evaluate outpatient magnetic resonance image-guided laser focal therapy for prostate cancer: A 20 year survival study (7 year interim results)

Abstract

In the United States alone, new prostate cancer cases for 2016 were estimated at 180,890 and deaths at 26,120. Focal therapies for low risk and intermediate risk localized prostate cancer are increasingly being explored. Additionally, new treatments for patients with biochemical recurrence of prostate cancer are also under investigation. Our objective is to investigate the safety and feasibility of using outpatient MR-guided laser focal therapy for MR visible prostate cancer utilizing a transrectal approach for laser applicator placement and therapy delivery in an outpatient setting while evaluating rates of biochemical recurrence, rates of metastatic disease and causes of death..

Results

Since May, 2010, 163 cancer foci from 113 men were treated in an outpatient setting. Total procedure time was between 1.5 and 4 hours. Coagulation necrosis volume ranged from 0.57 cc to 38.0 cc with a median of 6.7 cc. To date, no treatment-related deaths or serious adverse events have occurred. We have had 9 cases of late recurrence. Of the 126 treatment regions for which 6-month biopsy data was available, 34 regions (27%) were of marginal recurrence and 6 (5%) were of incidence; the remaining 68% were negative. When only considering treatment-naïve patients, 30/109 regions had marginal recurrence (28%) and 5/109 regions had incidence (5%) at 6 months. We observed a 44% decrease in mean PSA at 1 year post therapy (7.21 to 4.06, p < .001) and no statistically significant change in IPSS and SHIM scores at 6 months post-treatment.

Conclusions

Our interim data indicate that outpatient, transrectally delivered MRI- guided laser focal therapy for prostate cancer is both safe and feasible. In the current climate of cost-reduction and emphasis on minimally-invasive treatment of cancer, focal treatment of prostate cancer may be an attractive option. The precise energy delivery under MRI-guidance may have favorable results for cost control and quality of life without eliminating the possibility of whole-gland treatment in the patient’s future. We also observed that short term oncologic control is achievable in most patients and that only two research subjects have been diagnosed with metastatic disease to date. “

http://epo.epostersonline.net/focal2018/node/343?view=true

“Characterization of TRANBERG|Laser Applicator for Focal Laser Ablation (FLA) for prostate

Introduction

The use of ablative techniques in patients with low grade and intermediate localized prostate tumors represents a treatment option between active surveillance and radical prostatectomy. Focal laser ablation (FLA) appears to be a potential candidate to reach the goal of focusing energy delivery on the identified targets. Prostate tissue is particularly well suited for laser ablation due to its optical absorption rate and lack of excessive vascularity. FLA is magnetic resonance (MR)-compatible, it affords a significant imaging advantage over other surgical and ablative techniques that utilize transrectal ultrasound to guide and monitor treatment.

With the introduction of the TRANBERG|Thermal Therapy System on the market, already CE marked and FDA approved, a need of demonstration of the lesions sizes was identified. This work aims at characterizing the TRANBERG System for laser ablation of soft tissue to be used as a pre-planning tool for MR- or MR/US-fused- guided treatments in clinical settings.

Conclusion

The System is well fitted for highly precise and reliable ablation. The laser diffusing technology enables tailoring of heat distribution depending on tumor size and shape. Adaption of the ablation shape, in parallel with a temperature monitoring of surrounding sensitive structures, is essential for treatment of prostate cancer. The evaluation of ongoing clinical trials will show the potential of the laser ablation to become a widely applied method with demonstrated oncologic effectiveness. “

http://epo.epostersonline.net/focal2018/node/299?view=true

Vad innebär allt detta då? Slutsatser som kan dras är att FLA som metod är en behandlingseffektiv såväl som kostnadseffektiv och säker metod. Den lämpar sig väldigt väl för behandling utav prostatacancer och med hjälp utav CLS anpassningsbara icke-kylda diffusorfiber kommer resultaten sannolikt förbättras ännu mer, det är väl inte för inte som UTMB, Dessert Medical Imaging och Laser Prostate Centers of America samt nätverket International Laser Network intresserar sig för CLS och deras produkter. Den data som läggs fram utgör också underlag för de diskussioner som förs angående reimbursement för FLA, nu har det dock börjat komma igång och http://www.thefocaltherapyfoundation.org är ett sådant exempel men när nu fleråriga uppföljningsdata läggs fram så kommer sannolikt fler och fler ansluta sig.

För ungefär två veckor sedan kom nyheten att Dr. Leonard Marks och Shyam Natarajan på UCLA erhöll 3,1 MUSD från National Institute of Health (NIH) för att just avancera implementeringen utav FLA inom vården. Detta är staten som pekar med hela handen, metoden FLA skall implementeras. En metod som ligger i tiden på så många vis, återigen den är kostnadseffektiv, metoden är säker och minimalt invasiv. Men, främst är behandlingen effektiv och i jämförelse med de konventionella metoder vi idag erbjuds t.ex. i Sverige extremt skonsam. Tiden då skalpellen och strålning får konkurrens är här, varför skall en man idag läggas på operationsbordet, riskera inkontinens och erektionsproblem när det finns en behandling som effektivt dödar cancern men minimerar dessa risker enormt. Det är bara att titta på resultaten som presenteras, biverkningarna är i stort sett obefintliga i jämförelse och därmed bevaras inte bara patientens liv utan även livskvalité.

"The five-year research project will build upon previous groundbreaking work led by Marks and Natarajan at UCLA that demonstrated for the first time that focal laser ablation — the precise application of heat via laser to a tumor — could be safe and feasible when used in a clinical setting. Historically, prostate cancer has been treated with surgery and radiation, which can result in serious side effects such as erectile dysfunction and urinary incontinence.

Focal laser ablation provides a middle ground for men to choose between radical prostatectomy and active surveillance, for example as an alternative between doing nothing and losing the prostate,” Marks said. “This is a new and exciting concept for prostate cancer treatment; that a man walking into a clinic with prostate cancer and an hour or two later, walking out without prostate cancer, is not a pipe dream. We’ve seen it happen!"

https://www.newswise.com/articles/with-3.1m-grant-from-nih,-ucla-scientists-to-advance-adoption-of-focal-therapy-to-treat-prostate-cancer

CLS befinner sig i en bra position, bolagets kunder lovordar och ställer sig bakom produkterna och marknaden formeras i accelererande takt där CLS nu tack vare sitt nogranna förberedande arbete och välförtjänta position är redo att ta del utav tillväxten. CLS bör ligga väldigt väl till för att bli leverantör till den studie som UCLA skall bedriva med NIH pengarna. Därtill tror jag vi ser fler medlemmar inom ILN så som Weill Cornell inkomma som kunder. Möjligtvis kan det ske en geografisk expansion relativt snart då CLS skall bege sig till Kina för diskussioner med eventuella partners i landet. CLS sätter dock lasern på den medicinska världskartan i Europa under 2018 då vi kommer få se CLS kronjuvel avtäckas, imILT studiernas resultat skall presenteras och än så länge vet vi att "resultaten är bra" och väldigt intressanta speciellt när det gäller pankreascancer.

https://www.redeye.se/arena/posts/clinical-laserthermia-systems-innovatoer-inom-immunterapi-mot-cancer

https://www.redeye.se/arena/posts/clinical-laserthermia-systems-fraan-forskning-till-klinisk-anvaendning

https://www.redeye.se/arena/posts/clinical-laserthermia-systems-usa-marknaden

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