Robotic Waterjet Treatment for Prostate Cancer

Recruiting at 7 trial locations

Overseen By Angela Lee

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: PROCEPT BioRobotics

Disqualifiers: Previous prostate surgery, Severe illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new robotic waterjet treatment to manage prostate cancer and improve urinary symptoms. Researchers aim to evaluate the effectiveness and safety of the AQUABEAM Robotic System in removing prostate tissue. The trial targets individuals with localized prostate cancer who experience urinary problems and have not undergone previous prostate surgery. Participants will be monitored over 12 months to track progress and effects. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to improved prostate cancer treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that the AQUABEAM Robotic System is safe for prostate cancer treatment?

Research has shown that the AQUABEAM Robotic System, used in a treatment called Aquablation, offers a safe option for men with localized prostate cancer. This treatment alleviates urinary problems by removing prostate tissue. Studies have found Aquablation to be both effective and safe.

The procedure is minimally invasive, involving less cutting or entering the body. It uses a robotic waterjet to remove tissue without heat, protecting nearby areas from damage. This method has demonstrated effectiveness and is generally well-tolerated by patients.

While some side effects may occur, they are usually mild and temporary. Overall, the AQUABEAM Robotic System has been tested and presents a promising option for safely treating prostate issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for prostate cancer, which often involve surgery or radiation, the AQUABEAM Robotic System uses a waterjet to precisely remove prostate tissue. This technique, called Aquablation, is minimally invasive and aims to reduce the side effects commonly associated with other procedures. Researchers are excited because this approach can potentially offer quicker recovery times and less impact on urinary and sexual function, addressing significant concerns for many patients.

What evidence suggests that the AQUABEAM Robotic System is effective for prostate cancer?

Research has shown that the AQUABEAM Robotic System, used in Aquablation therapy, yields promising results for treating urinary problems related to prostate issues. Studies have found significant improvements in the International Prostate Symptom Score (IPSS), which measures the severity of urinary symptoms. Over four years, patients' scores improved from an average of 23.8 to 6.9, indicating much better symptom control. The therapy also increased the average peak urinary flow rate, allowing patients to urinate more easily. Clinical studies confirm that Aquablation is effective and safe for various prostate sizes and shapes. This trial will evaluate the AQUABEAM Robotic System as a treatment option for men with localized prostate cancer who have urinary symptoms. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men with lower urinary tract symptoms and localized prostate cancer. They must have a symptom score of 8 or higher, certain grades and sizes of cancer lesions, and a PSA level of 15ng/mL or less. The cancer should be at an early stage (T2c or less).

Inclusion Criteria

International Prostate Symptom Score (IPSS) ≥ 8

My prostate cancer is graded Gleason 1-3.

My cancer is at an early stage, not beyond T2c.

Exclusion Criteria

Any severe illness that would prevent complete study participation or confound study results

I have had surgery for an enlarged prostate.

My MRI shows my cancer has spread outside its original location.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments before treatment

1 week

Treatment

Participants receive treatment using the AQUABEAM Robotic System for resection and removal of prostate tissue

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• AQUABEAM Robotic System

Trial Overview

The AQUABEAM Robotic System, which uses waterjet technology to remove prostate tissue, is being tested for effectiveness and safety in patients with urinary symptoms due to prostate enlargement or cancer.

How Is the Trial Designed?

Group I: Aquablation Experimental Treatment 1 Intervention

AQUABEAM Robotic System is already approved in United States for the following indications:

Approved in United States as Aquablation Therapy for:

• Benign Prostatic Hyperplasia (BPH)
• Lower Urinary Tract Symptoms (LUTS)

Who Is Running the Clinical Trial?

PROCEPT BioRobotics

Lead Sponsor

Trials

14

Recruited

1,300+

Published Research Related to This Trial

The innovative 169 Yb-based rotating shield brachytherapy (RSBT) system can deliver higher doses to the prostate while sparing the urethra more effectively than conventional 192 Ir-based high-dose-rate brachytherapy (HDR-BT), with significant increases in target dose (PTV D90% increased by 29.9%) and reduced urethral exposure (D10% decreased by 23.1%).

The RSBT system allows for treatment in under an hour using a single-source robotic delivery method, demonstrating mechanical accuracy that supports its potential for safe and effective prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

169 Yb-based rotating shield brachytherapy for prostate cancer. Adams, Q., Hopfensperger, KM., Kim, Y., et al.[2022]

Brachytherapy, which involves the permanent implantation of radioactive seeds, shows promising results for treating early-stage prostate cancer, particularly in patients with favorable tumor characteristics, achieving biochemical failure rates comparable to radical prostatectomy.

While acute urinary retention occurred in 1%-14% of patients, long-term side effects were low (less than 5%), and a high percentage (86%-96%) of patients maintained sexual potency after treatment, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic overview of the evidence for brachytherapy in clinically localized prostate cancer. Crook, J., Lukka, H., Klotz, L., et al.[2018]

Stereotactic ablative body radiation (SABR) is a promising non-invasive treatment for localized prostate cancer, showing similar efficacy to brachytherapy in terms of disease control and lower side effects, making it a potentially safer option.

SABR is also more cost-effective and resource-efficient compared to traditional radiation techniques, but further well-powered studies are needed to confirm its benefits before it can be considered standard care, especially for patients with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. Loblaw, A., Liu, S., Cheung, P.[2023]

In a study of 33 patients with localized prostate cancer treated with modern proton beam radiotherapy (PBT), there were no severe acute toxicities, indicating a high safety profile for this treatment method.

With a median follow-up of 18 months, the use of hydrogel rectal spacers and fiducial tracking without endorectal balloons resulted in minimal treatment-related toxicity and promising oncologic outcomes, although late erectile dysfunction was noted as a common issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Cancer Treatment with Pencil Beam Proton Therapy Using Rectal Spacers sans Endorectal Balloons. Forsthoefel, M., Hankins, R., Ballew, E., et al.[2022]

Proton beam therapy (PBT) allows for higher radiation doses to be delivered to prostate cancer tissues while reducing exposure to surrounding healthy organs, making it a safer option for treatment.

Interest in PBT is growing due to improvements in treatment delivery systems and increased availability, highlighting the need for a comprehensive understanding of its effectiveness and technical aspects in treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam therapy for the treatment of prostate cancer. Pugh, TJ., Lee, AK.[2018]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06051942

PRCT001 Aquablation theraPy Outcomes in pRostate ...

The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in ...

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ir.procept-biorobotics.com/news-releases/news-release-details/ambulatory-surgery-center-completes-water-iv-trial-procedures

Ambulatory Surgery Center Completes WATER IV Trial ...

PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe, and durable outcomes for males suffering from lower urinary tract ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0090429524006253

Aquablation at 4-years: Real World Data From the Largest ...

International Prostate Symptom Score (IPSS) improved from a baseline of 23.8 (SD 8.4) to 6.9 (SD 2.9) at 4 years. Mean peak urinary flow rate (Qmax) also ...

4.

bjui-journals.onlinelibrary.wiley.com

bjui-journals.onlinelibrary.wiley.com/doi/10.1002/bco2.430

WATER versus WATER II 5-year update: Comparing ...

This study aims to compare the long-term outcomes of Aquablation for small-to-moderate (30–80 cm 3 ) prostates with the outcomes for large (80–150 cm 3 ) ...

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procept-biorobotics.com/

PROCEPT BioRobotics: Robotic Treatments for Men's Health

Clinical studies have shown that Aquablation therapy delivers safe, effective, and durable results regardless of prostate size or shape.1,2. References ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0090429525000342

Robotic Waterjet Resection for Men With Prostate Cancer ...

Aquablation may be considered a safe option for men with localized prostate cancer who require treatment for LUTS due to BPH.

7.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06051942/prct001-aquablation-therapy-outcomes-in-prostate-cancer-patients

PRCT001 Aquablation theraPy Outcomes in pRostate ...

The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue.

8.

water4pca.com

water4pca.com/

Enroll in Prostate Cancer Clinical Study | Water4Pca

Aquablation therapy. An advanced, minimally invasive surgical treatment that uses image guidance, robotics, and a heat-free waterjet to remove prostate tissue.