Aquablation Therapy for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates Aquablation therapy, a new treatment option, to assess its safety and effectiveness for men with localized prostate cancer. Aquablation uses water jets controlled by robotic systems to remove prostate tissue. The trial compares two groups: one receiving Aquablation therapy and the other under standard observation, known as active surveillance. Men diagnosed with prostate cancer within the last 18 months who have not yet received treatment may be suitable candidates for this study.
As an unphased trial, this study provides patients the opportunity to explore a cutting-edge treatment option that could potentially enhance their quality of life.
What prior data suggests that Aquablation Therapy is safe for prostate cancer treatment?
Previous studies have shown that Aquablation therapy is quite safe for treating prostate issues. One study found that Aquablation led to fewer problems with ejaculation (release of sperm) compared to another common procedure, with only 10% of patients experiencing this side effect, compared to 36% in the other group. Another study showed that even after five years, the need for further treatment remained very low, at just 3.7%. This suggests that the therapy is both safe and effective over the long term. Additionally, reports indicate that Aquablation improves urinary function while maintaining stable sexual function. Overall, research indicates that the treatment is well-tolerated with few adverse effects.12345
Why do researchers think this study treatment might be promising?
Aquablation Therapy for prostate cancer is unique because it uses a robotic system to deliver a high-velocity water jet to precisely remove prostate tissue. Unlike traditional treatments like surgery or radiation, which can have significant side effects, this method offers a minimally invasive approach with potentially fewer complications. Researchers are excited about this treatment because it promises greater precision and reduced recovery time, which could improve patients' quality of life while maintaining effective cancer control.
What evidence suggests that Aquablation Therapy is effective for prostate cancer?
Studies have shown that Aquablation therapy can effectively shrink the prostate and improve urinary symptoms. For example, one study found that prostate size reduced by an average of 41.3% after one year. Most men who underwent Aquablation therapy continued normal activities like urinating and ejaculating. Additionally, three men with prostate cancer underwent the procedure and experienced positive results. In this trial, participants in the Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or the HYDROS Robotic System. Early signs suggest that Aquablation therapy might be a promising option for treating localized prostate cancer.678910
Are You a Good Fit for This Trial?
This trial is for men aged 45 or older who have recently been diagnosed (within the past 18 months) with early-stage prostate cancer that hasn't spread. Their PSA must be under 15, and their prostate volume at least 25 ml. They should also be eligible for active surveillance.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either Aquablation Therapy or active surveillance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aquablation Therapy
Trial Overview
The study compares two approaches in men with localized prostate cancer: standard monitoring (active surveillance) versus a minimally invasive treatment called Aquablation therapy. Participants are randomly assigned to one of these groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System
The active surveillance arm will receive standard-of-care for prostate cancer management.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PROCEPT BioRobotics
Lead Sponsor
Citations
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 ...
BPH Treatment with Lasting Relief - Aquablation® US
In clinical studies, most men who received Aquablation therapy preserved continence, erections, and ejaculation.1. The Outcomes Men Deserve.
Aquablation at 4-years: Real World Data From the Largest ...
At 1 year, mean prostate volume reduction was 45.5 mL (−41.3%). Postoperative antegrade ejaculation was preserved in 249/250 men (99.6)% of men. Complications ...
4.
urologytimes.com
urologytimes.com/view/aquablation-procedures-for-prostate-cancer-completed-at-ambulatory-surgery-centerAquablation procedures for prostate cancer completed at ...
Three patients with prostate cancer have successfully underwent Aquablation procedures in an ambulatory surgery center (ASC), ...
A Narrative Review of Robotic Aquablation in Benign Prostatic ...
Zorn et al. reported durable three-year outcomes after Aquablation: peak urinary flow nearly doubled to 18.5 mL/s, post-void residual fell ...
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 ...
Complication Profile and Safety Outcomes of Aquablation in ...
Compared with transurethral resection of the prostate, Aquablation yielded lower rates of ejaculatory dysfunction (10% vs. 36%), with continence ...
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
Aquablation at 4-years: Real World Data from the Largest ...
These results have been confirmed in recent 5-year follow-up data showing a sustained response and a retreatment rate as low as 3.7%.4. Several ...
10.
urologytimes.com
urologytimes.com/view/fda-approves-study-of-aquablation-vs-radical-prostatectomy-in-prostate-cancerFDA approves study of Aquablation vs radical ...
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