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Investigator Initiated Trial to Further Evaluate the Safety and Efficacy of Trans-perineal Focal Laser Ablation of Localized Prostate Cancer Using High Frequency Micro-ultrasound Imaging

NCT05826470 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-12-10

No results posted yet for this study

Summary

Trans-perineal focal laser ablation represents a promising alternative focal therapy option for patients with low-risk or favorable intermediate risk prostate cancer. FLA has been extensively utilized for over a decade in the treatment of PCa using different anatomical approaches. The proposed study differs from past ones in that a trans-perineal approach with reduced risk of infection will be used in contrast to the current trans-rectal approach. In addition, high frequency micro-ultrasound imaging will be used to enhance imaging and facilitate accurate needle placement and FLA of the index lesions.

The aim of this study is to evaluate FLA as a potential optimal therapeutic intervention based on safety, ease of use, efficacy, and cost.1 FLA holds promise for the management of localized tumors. The combination of the trans-perineal focal laser ablation and micro-ultrasound imaging will enable targeted trans-perineal fusion laser induced thermal therapy of prostate cancer lesions. This approach offers significant potential advantages over traditional interventions including:

* Improved dynamic ultrasound imaging of the lesion to be treated compared to traditional ultrasound techniques.
* Enhanced ability to visualize and spare critical structures within the prostate, including the bladder neck, neurovascular bundle (NVB), urethral sphincter and organs in close proximity including the rectum.
* Sparing these structures should translate into improved preservation of ejaculation, limited changes in sexual function and minimal transient incontinence following treatment.

Conditions

  • Prostate Cancer
  • Low-risk or Favorable Intermediate Risk Prostate Cancer Who Are on an Active Surveillance Regimen

Interventions

DEVICE

TRANBERG®|Thermal Therapy System

Focal laser ablation.

Sponsors & Collaborators

  • Genesis Research LLC

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2024-12-05
Completion
2024-12-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05826470 on ClinicalTrials.gov