Aquablation Therapy vs Radical Prostatectomy for Prostate Cancer

(WATER IV PCa Trial)

Recruiting at 43 trial locations

Overseen By Angela Lee

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: PROCEPT BioRobotics

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Other cancer, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Aquablation Therapy, a minimally invasive surgical procedure, to determine its safety and effectiveness for men with localized prostate cancer. Researchers aim to compare it to the standard surgery option, radical prostatectomy, over the next 10 years. Men recently diagnosed with low to high-risk prostate cancer who are considering surgery might be suitable candidates for this study. As an unphased trial, it offers patients the chance to contribute to groundbreaking research and potentially benefit from innovative treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you must be able to stop anticoagulants or antiplatelet agents before the study treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Aquablation Therapy is generally safe for men with localized prostate cancer. Studies have found it to be a safe option for treating urinary symptoms caused by an enlarged prostate. This treatment uses a robotic waterjet to remove prostate tissue and is well-tolerated by patients. Reports indicate that Aquablation Therapy provides effective and lasting results and can be used for prostates of various sizes and shapes. Overall, these findings suggest that Aquablation Therapy is a promising and safe treatment option for those considering it. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Aquablation Therapy is unique because it uses a high-velocity waterjet, guided by robotic systems like the AQUABEAM or HYDROS, to remove prostate tissue. Unlike the standard surgical option of radical prostatectomy, which involves removing the prostate gland through an invasive procedure, Aquablation is minimally invasive and aims to reduce recovery time and side effects. Researchers are excited about Aquablation because it offers precision and potentially less damage to surrounding tissues, which could lead to better outcomes and a faster return to normal activities for patients.

What evidence suggests that Aquablation Therapy might be an effective treatment for prostate cancer?

This trial will compare Aquablation Therapy with Radical Prostatectomy for treating prostate cancer. Research has shown that Aquablation Therapy, a robotic procedure, effectively treats prostate issues like benign prostatic hyperplasia (BPH). Studies have found that it safely and effectively relieves urinary symptoms related to BPH, regardless of the prostate's size or shape. While most research focuses on BPH, the precise robotic technology and ability to remove tissue suggest potential benefits for prostate cancer treatment. This method uses water to remove prostate tissue, offering a less invasive alternative to traditional surgery. Early findings suggest it could be a promising option for prostate cancer, but specific data on cancer outcomes is still being developed. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men with low to high-risk localized prostate cancer who are candidates for or have chosen to undergo prostatectomy. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am a man aged 45 or older.

PSA ≤ 20 ng/ml

I am eligible for prostate surgery or have chosen a radical treatment for my low-grade prostate cancer.

Exclusion Criteria

I have had surgery or a minor procedure for an enlarged prostate in the last 3 months.

I have had treatments for prostate cancer, such as surgery or hormone therapy.

Current participation in other studies unless approved by Sponsor in writing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either Aquablation Therapy or radical prostatectomy

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Aquablation Therapy

Trial Overview The study compares Aquablation Therapy, a minimally invasive waterjet treatment, with the traditional surgical method of radical prostatectomy in treating prostate cancer over up to a decade.

How Is the Trial Designed?

Group I: Aquablation Therapy Experimental Treatment 1 Intervention

The Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System

Group II: Radical Prostatectomy Active Control 1 Intervention

The radical prostatectomy arm will receive the standard of care radical prostatectomy procedure.

Who Is Running the Clinical Trial?

PROCEPT BioRobotics

Lead Sponsor

Trials

14

Recruited

1,300+

Published Research Related to This Trial

Radical prostatectomy has been shown to improve cancer-specific mortality and metastasis-free survival compared to observation in several randomized controlled trials, making it a potentially beneficial option for men with aggressive prostate cancer.

All aggressive treatments for prostate cancer, including radical prostatectomy, can negatively affect erectile function and urinary continence, highlighting the importance of shared decision-making that considers both treatment benefits and patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Surgical Management of Prostate Cancer. Sebesta, EM., Anderson, CB.[2019]

Both radiotherapy and radical prostatectomy show similar cancer control rates at 10 years for localized prostate cancer, indicating that either treatment can be effective.

For patients older than the youngest age group, the decision between radiotherapy and surgery should prioritize factors like treatment-related toxicity and quality of life rather than just cancer control outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Localized prostate cancer: radiation or surgery? Klein, EA., Kupelian, PA.[2019]

For low-risk localized prostate cancer, both radical prostatectomy and ultrasound-guided transperineal brachytherapy are effective, controlling the disease in over 80% of cases, with no clear evidence favoring one treatment over the other.

In high-risk prostate cancer patients, neither radical prostatectomy nor brachytherapy consistently achieves biochemical control rates above 50%, suggesting that external-beam radiation therapy combined with androgen deprivation is currently the most effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing radical prostatectomy and brachytherapy for localized prostate cancer. Quaranta, BP., Marks, LB., Anscher, MS.[2015]

Radical prostatectomy is still considered the 'gold standard' treatment for clinically localized prostate cancer, but many patients are seeking minimally invasive alternatives due to concerns about the risks associated with open surgery.

Minimally invasive options like laparoscopic radical prostatectomy, robotic-assisted laparoscopic prostatectomy, brachytherapy, cryotherapy, and high-intensity focused ultrasound are gaining popularity among patients, as they may offer better quality of life outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive surgical approaches and management of prostate cancer. Gonzalgo, ML., Patil, N., Su, LM., et al.[2008]

Radical prostatectomy remains a key treatment for prostate cancer, with laparoscopic and robotic techniques showing comparable outcomes in terms of operative time, transfusion rates, and recovery metrics.

While open radical prostatectomy is known for excellent long-term cancer control, there is limited short-term data on laparoscopic and robotic methods, indicating a need for further research to determine if these minimally invasive options offer significant benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical comparison of laparoscopic, robotic, and open radical prostatectomy: techniques, outcomes, and cost. Gettman, MT., Blute, ML.[2019]

Citations

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

Aquablation at 4-years: Real World Data From the Largest ... Our study demonstrates that Aquablation treatment for BPH at 4-years of follow-up is safe and provides durable outcomes for patients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06051942?cond=Benign%20Prostatic%20Hyperplasia&term=focused%20ultrasound&aggFilters=status:not%20rec&rank=4

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 ...

3. 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.

4. procept-biorobotics.com 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 ...

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

Aquablation Therapy in Large Prostates (80-150 mL) for ... Purpose:We report 5-year safety and efficacy outcomes of the Aquablation procedure for the treatment of men with symptomatic benign ...

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. 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 ...

9. 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 ...