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NCT05698576 · ClinicalTrials.gov registry record · NA
TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer
A NA study of Prostate Cancer and Urinary Incontinence, sponsored by Urological Research Network.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05698576 is a NA study of Prostate Cancer and Urinary Incontinence that is actively recruiting participants, run by Urological Research Network. The registered enrollment target is 20 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05698576, a NA study of Prostate Cancer and Urinary Incontinence, is actively recruiting participants, sponsored by Urological Research Network.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is set up as a phase I prospective, single center, device interventional pilot study carried in office setting under local anesthesia. It will assess the tolerance and safety of target fusion ablation of prostate cancer tumors using Laser Induced Thermal Therapy (TFA-LITT) guided by fusion imaging in men 50 to 80 years of age with low to intermediate risk prostate cancer Prostate Cancer is currently managed with in a discrete fashion where patients either enroll in active surveillance protocols (No intervention) or undergo full intervention via whole gland treatments - most commonly radical surgery or radiation. These treatments have not shown definitive gains in all cause survival and not uncommonly harbor undesirable adverse effects, most notably: impotency and incontinence. Such events elicit significant and noticeable changes on a male lifestyle and for most prostate cancer tumors are considered overtreatment. This study aims to evaluate the use of TFA-LITT in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk - focused on the organ sparing cancer lesion ablation, where organ function is preserved. The fundamental objective is to determine the tolerance and safety of TFA-LITT in men with low to intermediate risk prostate cancer, successful performed in the outpatient office-based setting under local anesthesia directed by fusion imaging. Secondary objectives include: 1-Biopsy proven cancer control of ablated areas 12 months after procedure; 2-Uroflowmetry and urinary function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 3- Sexual function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 4- MRI changes of ablated area one, three and 12 months after TFA-LITT; 5- Absence or presence of ejaculation after TFA-LITT.
Conditions Studied
Interventions
- DEVICE TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT)
Study Locations (1)
Florida
- Urology Specialist Group - Hialeah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-03-16 |
| Est. Completion | 2033-01-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05698576
The ClinicalTrials.gov registry entry for NCT05698576 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Urological Research Network, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT) is the first listed.
NCT05698576 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT05698576 about?
NCT05698576 is a clinical study titled "TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer". This study is set up as a phase I prospective, single center, device interventional pilot study carried in office setting under local anesthesia. It will assess the tolerance and safety of target fusion ablation of prostate cancer tumors using Laser Induced Thermal Therapy (TFA-LITT) guided by fusio...
What is the current status of trial NCT05698576?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2022-03-16. Estimated completion is 2033-01-30.
What conditions does trial NCT05698576 study?
This clinical trial studies the following conditions: Prostate Cancer, Urinary Incontinence, MRI, Ablation, Ultrasound.
What interventions are being tested in trial NCT05698576?
The interventions under investigation include: TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT) (DEVICE).
Who is sponsoring clinical trial NCT05698576?
This trial is sponsored by Urological Research Network, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05698576 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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