PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-22

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia Localized Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aquablation

Group Type EXPERIMENTAL

Robotic Waterjet Treatment

Intervention Type DEVICE

The Aquablation therapy is a minimally invasive, image-guided, heat-free robotic therapy delivered by the AQUABEAM Robotic System. During Aquablation therapy, the AQUABEAM Handpiece is inserted transurethrally into the prostatic urethra. The operating physician then utilizes cystoscopy in conjunction with transrectal ultrasound (TRUS) imaging for real time visualization. The AQUABEAM Robotic System utilizes high-velocity sterile saline waterjet to resect and remove the prostate tissue according to the operating physician's treatment plan.

Interventions

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Robotic Waterjet Treatment

The Aquablation therapy is a minimally invasive, image-guided, heat-free robotic therapy delivered by the AQUABEAM Robotic System. During Aquablation therapy, the AQUABEAM Handpiece is inserted transurethrally into the prostatic urethra. The operating physician then utilizes cystoscopy in conjunction with transrectal ultrasound (TRUS) imaging for real time visualization. The AQUABEAM Robotic System utilizes high-velocity sterile saline waterjet to resect and remove the prostate tissue according to the operating physician's treatment plan.

Intervention Type DEVICE

Other Intervention Names

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Aquablation therapy

Eligibility Criteria

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Inclusion Criteria

* International Prostate Symptom Score (IPSS) ≥ 8
* Gleason Grade Group 1-3
* Prostate-specific Antigen (PSA) ≤20ng/mL
* Cancer stage less than or equal to T2c

Exclusion Criteria

* Patients with previous surgical treatment of benign prostatic hyperplasia
* MRI evidence of extracapsular extension of cancer
* Any severe illness that would prevent complete study participation or confound study results

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No