Robotic Waterjet Treatment for Prostate Cancer

Not currently recruiting at 4 trial locations

Overseen By Angela Lee

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: PROCEPT BioRobotics

Disqualifiers: Prostate cancer treatment, Bone metastasis, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of the AQUABEAM Robotic System for treating localized prostate cancer, focusing on a robotic waterjet technique to target the prostate. Men eligible for this trial have been diagnosed with prostate cancer that remains confined to the prostate and have not received any prior prostate cancer treatments. As an unphased trial, it offers patients the opportunity to contribute to innovative research in prostate cancer treatment.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that the AQUABEAM Robotic System is generally safe for treating prostate problems. Studies have found that this system effectively removes prostate tissue and maintains a good safety record. Aquablation therapy, using the AQUABEAM system, is well-tolerated by men with localized prostate conditions. It treats symptoms like difficulty urinating caused by an enlarged prostate, also known as BPH (benign prostatic hyperplasia).

Safety data indicate that while some men may experience issues like erectile or ejaculatory dysfunction, these are uncommon. Most patients undergo the procedure without serious or lasting side effects. The system provides precise treatment, reducing risks. In summary, past research has shown the AQUABEAM Robotic System to have a good safety profile, making it a promising option for those considering treatment for prostate issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AQUABEAM Robotic System is unique because it uses a high-pressure waterjet to precisely remove prostate tissue in a minimally invasive way. Unlike traditional treatments for prostate cancer, which often involve surgery or radiation, this approach reduces the risk of damaging surrounding tissues and minimizes side effects. Researchers are excited because this robotic technique offers greater precision and potentially quicker recovery times compared to existing options like prostatectomy or radiation therapy.

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

Research shows that the AQUABEAM Robotic System, used in Aquablation therapy, delivers promising results for treating prostate issues. Studies have found that Aquablation improves urinary function and either maintains or enhances sexual function. It has also provided long-term relief for men with enlarged prostates, with a low likelihood of needing additional treatments. The system uses a waterjet to precisely remove prostate tissue, minimizing the risk of harming nearby areas. In this trial, participants will receive Aquablation as an experimental treatment option for managing localized prostate cancer. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

Men with localized prostate cancer who haven't had previous treatments for an enlarged prostate in the last year, have a prostate volume of at least 30 ml, PSA levels at or below 20 ng/ml, and are classified as Grade Group 1 or 2. Men with advanced disease like bone metastasis, lymph node involvement confirmed by biopsy/PET scan, extracapsular spread, seminal vesicle invasion or any other serious health risks are not eligible.

Inclusion Criteria

My prostate is larger than 30 ml.

My prostate cancer is low grade, and I have 3 or more positive biopsy cores.

My cancer is in an early stage and has not spread widely.

Exclusion Criteria

My scans or biopsy confirm I have suspicious lymph node involvement.

My cancer has spread to my bones.

I had surgery or a minimally invasive treatment for an enlarged prostate in the last year.

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 with the AQUABEAM Robotic System

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 trial is testing the AQUABEAM Robotic System's safety for treating localized prostate cancer. Participants will undergo this robotic waterjet treatment and be monitored through various assessments over a period of up to one year.

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+

Citations

1. 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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0090429525000342

Robotic Waterjet Resection for Men With Prostate Cancer ... In an active surveillance population, Aquablation resulted in improved urinary function, stable or improved sexual function, and a transient spike in CTCs ...

3. ir.procept-biorobotics.com 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 ...

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003483

Aquablation Therapy in Large Prostates (80-150 mL) for ... At 5-years of prospective follow-up, the Aquablation procedure was shown to be safe with durable efficacy and low rates of retreatment in men ...

5. aquablation.com aquablation.com/

BPH Treatment with Lasting Relief - Aquablation® US Aquablation therapy is a safe and effective treatment for patients suffering from LUTS due to BPH. It can be performed on prostates of any size and shape.

6. 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.

7. procept-biorobotics.com procept-biorobotics.com/healthcare-providers/clinical-data

Clinical Data Supporting Aquablation for BPH The safety profile of Aquablation therapy is characterized by the incidence of irreversible complications, such as erectile dysfunction, ejaculatory dysfunction ...