Aquablation Therapy vs Radical Prostatectomy for Prostate Cancer

(WATER IV PCa Trial)

Recruiting at43 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: PROCEPT BioRobotics

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Other cancer, Cognitive impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a multicenter, prospective, randomized clinical trial that aims to assess the safety and efficacy of Aquablation Therapy in men with low-risk to intermediate to high-risk localized prostate cancer who are candidates for, or have opted for, prostatectomy. Participants will be randomized to either Aquablation Therapy or radical prostatectomy and followed up to 10 years.

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.

How does Aquablation Therapy differ from other treatments for prostate cancer?

Aquablation Therapy is unique because it uses a high-pressure water jet to remove prostate tissue, which is a minimally invasive approach compared to traditional surgery like radical prostatectomy. This method may offer benefits in terms of reduced recovery time and potentially fewer side effects related to urinary and sexual function. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Aquablation Therapy (Procedure)

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

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

Comparing radical prostatectomy and brachytherapy for localized prostate cancer. [2015]

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

The Surgical Management of Prostate Cancer. [2019]

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

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

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

Localized prostate cancer: radiation or surgery? [2019]

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

Minimally invasive surgical approaches and management of prostate cancer. [2008]