Robotic Waterjet Treatment for Prostate Cancer

Recruiting at 6 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

Trial Summary

What is the purpose of this trial?

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 patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.

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.

How is the AQUABEAM Robotic System treatment for prostate cancer different from other treatments?

The AQUABEAM Robotic System, also known as Aquablation Therapy, is unique because it uses a robotic waterjet to precisely remove prostate tissue, offering a minimally invasive option that reduces the risk of damage to surrounding areas compared to traditional surgical or radiation treatments. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prostate Cancer Treatment with Pencil Beam Proton Therapy Using Rectal Spacers sans Endorectal Balloons. [2022]

2. China pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

169 Yb-based rotating shield brachytherapy for prostate cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Proton beam therapy for the treatment of prostate cancer. [2018]

5. Canada pubmed.ncbi.nlm.nih.gov

Systematic overview of the evidence for brachytherapy in clinically localized prostate cancer. [2018]