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Targeted Microwave Focal Therapy

NCT04627896 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-02-02

No results posted yet for this study

Summary

Focal therapy (FT) for prostate cancer (PCa) is an interesting therapeutic option for localized disease with a favorable low- to intermediate-risk profile. The aim of this approach is to offer a personalized and less aggressive treatment as compared to radical treatments such as radical prostatectomy (RP) or primary radiation therapy, reducing functional morbidity while maintaining oncologic efficiency.

FT is based on the treatment of a part of the prostate, containing the index lesion. The index lesion is identified as a single visible lesion up to 12 mm at multiparametric MRI (mpMRI), which is biopsied with a fusion biopsy obtaining a Gleason score inferior or equal to 3+4. These features allow a focal treatment aimed to ablate the area containing the tumor. In case of a concomitant presence of 1 or 2 cores of Gleason score 3+3 found at systematic biopsy and invisible to mpMRI, a strategy of surveillance will be adopted, focusing the treatment only on the index lesion (only in patients older than 70 years old). Different sources of energy have been used to date for focal therapy. Among these, has emerged a very low loss (VLL) microwave ablation system, called TATO3®, specifically developed to work with the fusion biopsy platform Koelis Trinity® that allows an accurate 3D reconstruction of the prostate, with the goal to offer a targeted treatment after a targeted biopsy. Aim of this experimental trial is to evaluate the efficacy of the Trinity®-guided TATO3® treatment in the ablation of the index lesion, together with the safety of the procedure and the short-term oncologic outcomes.

Conditions

  • Prostate Cancer Stage I

Interventions

DEVICE

Katty focal therapy

Microwave ablation with TATO3 generator (Katty system) under guidance of ultrasound/mpMRI fusion image device Trinity

Sponsors & Collaborators

  • Koelis

    collaborator INDUSTRY

  • A.O.U. Città della Salute e della Scienza

    lead OTHER

Principal Investigators

  • Marco Oderda, MD, PhD · A.O.U. Città della Salute e della Scienza di Torino

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2022-09-30
Completion
2022-12-30

Countries

  • Italy

Study Locations

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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 NCT04627896 on ClinicalTrials.gov