PROCEPT BioRobotics Received U.S. FDA Approval to Initiate Pivotal Randomized Clinical Study for Prostate Cancer
PROCEPT BioRobotics (Nasdaq: PRCT) has received FDA approval to initiate a pivotal randomized clinical study for prostate cancer treatment. The WATER IV PCa trial will compare Aquablation therapy to radical prostatectomy in men with Grade Group 1 to 3 localized prostate cancer. This global multicenter study will enroll up to 280 patients across 50 centers, with a 10-year follow-up period.
The FDA has also granted Breakthrough Device Designation for Aquablation therapy in prostate cancer treatment. The study's co-primary endpoint focuses on morbidity at six months, with longer-term follow-up assessing treatment-related harm reduction and oncologic events. This trial could potentially revolutionize localized prostate cancer treatment for millions of men.
PROCEPT BioRobotics (Nasdaq: PRCT) ha ricevuto l'approvazione della FDA per avviare uno studio clinico randomizzato cruciale per il trattamento del cancro alla prostata. Il trial WATER IV PCa confronterà la terapia Aquablation con la prostatectomia radicale in uomini con cancro alla prostata localizzato di Gruppo di Grado 1 a 3. Questo studio multicentrico globale prevede di arruolare fino a 280 pazienti in 50 centri, con un periodo di follow-up di 10 anni.
La FDA ha anche concesso la Designazione Dispositivo Innovativo per la terapia Aquablation nel trattamento del cancro della prostata. L'obiettivo co-primario dello studio si concentra sulla morbidità a sei mesi, mentre il follow-up a lungo termine valuterà la riduzione dei danni correlati al trattamento e gli eventi oncologici. Questo trial potrebbe potenzialmente rivoluzionare il trattamento del cancro alla prostata localizzato per milioni di uomini.
PROCEPT BioRobotics (Nasdaq: PRCT) ha recibido la aprobación de la FDA para iniciar un estudio clínico aleatorizado pivotal para el tratamiento del cáncer de próstata. El ensayo WATER IV PCa comparará la terapia de Aquablation con la prostatectomía radical en hombres con cáncer de próstata localizado de Grupo de Grado 1 a 3. Este estudio multicéntrico global incluirá hasta 280 pacientes en 50 centros, con un período de seguimiento de 10 años.
La FDA también ha otorgado la Designación de Dispositivo Innovador para la terapia de Aquablation en el tratamiento del cáncer de próstata. El objetivo co-principal del estudio se centra en la morbilidad a los seis meses, mientras que el seguimiento a largo plazo evaluará la reducción del daño relacionado con el tratamiento y los eventos oncológicos. Este ensayo podría revolucionar potencialmente el tratamiento del cáncer de próstata localizado para millones de hombres.
PROCEPT BioRobotics (Nasdaq: PRCT)는 전립선암 치료를 위한 결정적인 무작위 임상 연구를 시작하기 위해 FDA의 승인을 받았습니다. WATER IV PCa 시험은 1~3등급의 국소 전립선암 환자에서 아쿠아블레이션 요법과 근치적 전립선절제술을 비교할 것입니다. 이 글로벌 다기관 연구는 50개 센터에서 최대 280명의 환자를 모집하며, 10년의 추적 조사를 실시할 예정입니다.
FDA는 전립선암 치료를 위한 아쿠아블레이션 요법에 대해 혁신적 기기 지정을 부여했습니다. 연구의 공동 주요 목표는 6개월 시점에서의 이환율에 초점을 맞추고, 장기 추적 기간에는 치료 관련 손상 감소와 종양학적 사건을 평가할 것입니다. 이 임상 시험은 수백만 남성의 국소 전립선암 치료를 혁신적으로 변화시킬 잠재력이 있습니다.
PROCEPT BioRobotics (Nasdaq: PRCT) a reçu l'approbation de la FDA pour initier une étude clinique pivot randomisée pour le traitement du cancer de la prostate. L'essai WATER IV PCa comparera la thérapie Aquablation à la prostatectomie radicale chez des hommes présentant un cancer de la prostate localisé de Groupe de Grade 1 à 3. Cette étude multicentrique mondiale recrutera jusqu'à 280 patients dans 50 centres, avec une période de suivi de 10 ans.
La FDA a également accordé la Désignation de Dispositif Innovant pour la thérapie Aquablation dans le traitement du cancer de la prostate. L'objectif co-principal de l'étude se concentre sur la morbidité à six mois, avec un suivi à long terme évaluant la réduction des dommages liés au traitement et les événements oncologiques. Cet essai pourrait potentiellement révolutionner le traitement du cancer de la prostate localisé pour des millions d'hommes.
PROCEPT BioRobotics (Nasdaq: PRCT) hat die Genehmigung der FDA erhalten, eine entscheidende randomisierte klinische Studie zur Behandlung von Prostatakrebs zu beginnen. Die WATER IV PCa-Studie wird Aquablationstherapie mit radikaler Prostatektomie bei Männern mit lokalisiertem Prostatakrebs der Grade 1 bis 3 vergleichen. Diese globale multizentrische Studie wird bis zu 280 Patienten an 50 Zentren einschließen, mit einer Nachbeobachtungszeit von 10 Jahren.
Die FDA hat auch die Breakthrough Device Designation für die Aquablationstherapie bei der Behandlung von Prostatakrebs erteilt. Das Hauptziel der Studie konzentriert sich auf die Morbidität nach sechs Monaten, während die langfristige Nachverfolgung die Reduzierung behandlungsbedingter Schäden und onkologischer Ereignisse bewertet. Diese Studie könnte möglicherweise die Behandlung des lokalisierten Prostatakrebses für Millionen von Männern revolutionieren.
- FDA approval for pivotal Investigational Device Exemption (IDE) clinical trial
- Breakthrough Device Designation received for Aquablation therapy in prostate cancer
- Potential to become a first-line treatment for localized prostate cancer
- Large-scale study: up to 280 patients across 50 centers with 10-year follow-up
- None.
Insights
The FDA's approval for PROCEPT BioRobotics to initiate a pivotal randomized clinical study for prostate cancer treatment is a significant development in the urology field. This study, WATER IV PCa, comparing Aquablation therapy to radical prostatectomy, could potentially revolutionize prostate cancer treatment.
Key points:
- The study will enroll up to 280 patients across 50 centers, with a 10-year follow-up.
- It received Breakthrough Device Designation, indicating its potential to significantly improve patient outcomes.
- The primary focus is on reducing treatment-related harm while maintaining oncologic efficacy.
If successful, this study could position Aquablation therapy as a first-line treatment for localized prostate cancer, potentially offering improved safety and quality of life outcomes compared to current standards. This represents a major market opportunity for PROCEPT BioRobotics, as no other energy-based treatment currently has a prostate cancer-specific indication.
This FDA approval for PROCEPT BioRobotics' clinical trial is a significant milestone with substantial financial implications. Key financial considerations include:
- Market Expansion: Success in this trial could dramatically expand PROCEPT's addressable market, potentially including millions of prostate cancer patients.
- Competitive Advantage: Being the first energy-based treatment with a prostate cancer-specific indication would give PROCEPT a significant edge in the urology market.
- Long-term Growth: The 10-year follow-up period suggests a long-term commitment to proving efficacy, which could translate to sustained revenue growth if successful.
- R&D Investment: While the trial represents a significant R&D expense, the potential return on investment could be substantial if Aquablation becomes a standard treatment for prostate cancer.
Investors should monitor the progress of this trial closely, as positive results could significantly impact PROCEPT's market valuation and future revenue projections.
A Prospective, Randomized, Multicenter Study Assessing the Safety and Efficacy of Aquablation Therapy in Men with Grade Group 1 to 3 Localized Prostate Cancer
Represents Potential Paradigm Shift in How Urologists Might Treat Localized Prostate Cancer
SAN JOSE, Calif., Oct. 07, 2024 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced the U.S. Food and Drug Administration (FDA) has approved a pivotal Investigational Device Exemption (IDE) clinical trial comparing Aquablation therapy to radical prostatectomy. The Company also recently received Breakthrough Device Designation to investigate the use of Aquablation therapy for prostate cancer. Breakthrough Device Designation is awarded in exceptional cases, expediting the review of novel therapies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.
The trial, known as WATER IV PCa, is a global multicenter, prospective, randomized clinical study assessing the safety and efficacy of Aquablation therapy compared to radical prostatectomy in men with Grade Group 1 to 3 localized prostate cancer. The study will enroll up to 280 patients at up to 50 centers and follow them for 10 years. There is a co-primary endpoint based on morbidity evaluated at the six-month follow-up. Longer-term follow-up focuses on both the reduction in treatment related harm and oncologic events.
“WATER IV PCa, a unique and thoughtful trial design focusing on harm reduction by using Aquablation as first line treatment in comparison to radical prostatectomy, could potentially change the way urologists treat localized prostate cancer for millions of men,” said, Inderbir Gill, MD, founding executive director of USC Urology, part of Keck Medicine of USC and chairman, Catherine & Joseph Aresty Department of Urology, Keck School of Medicine of USC. “It is exciting to see that the FDA approved an IDE after a prompt and thorough review of the trial design, and we look forward to seeing the results of the forthcoming trial and are hopeful about the possibilities of this novel technology.”
“A significant opportunity exists to improve safety and quality of life outcomes for men needing treatment for prostate cancer. We believe Aquablation therapy has the ability to become a first line treatment for localized prostate cancer. Initiating a randomized trial against radical prostatectomy is the first big step in pursuing a prostate cancer specific indication– which no other energy-based treatment has today,” said Reza Zadno, Chief Executive Officer of PROCEPT BioRobotics.
About Aquablation Therapy
Aquablation therapy is the first and only ultrasound guided, robotic-assisted, heat-free waterjet for the treatment of BPH. The system’s real-time ultrasound imaging provides the surgeon with a multi-dimensional view of the prostate enabling personalized treatment planning tailored to each patient’s unique anatomy. The surgeon can specify which areas of the prostate to remove while preserving the anatomy that controls erectile function, ejaculatory function and continence. Once the treatment plan is mapped by the surgeon, the predictable robotic-assisted execution enables prostate tissue to be removed in a precise, targeted, and controlled fashion.
About PROCEPT BioRobotics Corporation
PROCEPT BioRobotics is a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. PROCEPT BioRobotics manufactures the AQUABEAM and HYDROS Robotic Systems. The HYDROS Robotic System is the only AI-Powered, robotic technology that delivers Aquablation therapy. PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe, and durable outcomes for males suffering from lower urinary tract symptoms or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. The Company has developed a significant and growing body of clinical evidence with over 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy.
Forward Looking Statements
This release contains forward‐looking statements within the meaning of federal securities laws, including with respect to the Company’s projected financial performance for full year 2024 and statements regarding the potential utilities, values, benefits and advantages of Aquablation® therapy performed using PROCEPT BioRobotics’ products, including the HYDROS™ Robotic System, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware. Forward-looking statements may include statements regarding financial guidance, market opportunity and penetration, the Company’s possible or assumed future results of operations, including descriptions of the Company’s revenues, gross margin, profitability, operating expenses, installed base growth, commercial momentum, reimbursement coverage, overall business strategy, or information regarding the impact of other global events on the Company and its operations. Forward‐looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward‐looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward‐looking statements as a result of these risks and uncertainties. These risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s annual report on Form 10-K filed with the SEC on February 28, 2024. PROCEPT BioRobotics does not undertake any obligation to update forward‐looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward‐looking statements contained herein. These forward-looking statements should not be relied upon as representing PROCEPT BioRobotics’ views as of any date subsequent to the date of this press release.
Important Safety Information
All surgical treatments have inherent and associated side effects. For a list of potential side effects visit https://aquablation.com/safety-information/.
Investor Contact:
Matt Bacso
VP, Investor Relations and Business Operations
m.bacso@procept-biorobotics.com
Media Contact:
Lauren Cohen
Senior Director, Integrated Marketing Communications
l.cohen@procept-biorobotics.com
FAQ
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