MedTrace Logo

Phase II Laser Focal Therapy of Prostate Cancer

NCT02243033 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-03-25

No results posted yet for this study

Summary

Target recruitment: 1000 subjects. The purpose of this research study is to continue to investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize that laser focal therapy can be used to achieve oncologic control in carefully selected patients.

MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses light to heat a target area to try to destroy cancerous cells.

The laser system that will be used is called the Visualase® Thermal Therapy System. This system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers. However; this study is the first time this system has been studied for use in the treatment of prostate cancer with a trans-rectal approach.

MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and Drug Administration (FDA) for such uses.

Conditions

Interventions

DEVICE

MR-guided laser focal therapy

Placement of laser applicator under MRI guidance and real-time MR thermal imaging of tissue necrosis.

Sponsors & Collaborators

  • HALO Diagnostics

    lead INDUSTRY

Principal Investigators

  • John F. Feller, MD · HALO Diagnostics

  • Bernadette M. Greenwood, MSc · HALO Diagnostics

Eligibility

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

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2036-05-31
Completion
2036-11-30

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 NCT02243033 on ClinicalTrials.gov