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Clinical Trials in the USA / NCT02243033
Active, not recruiting Observational

Phase II Laser Focal Therapy of Prostate Cancer

NCT02243033 · tracked via the Priya Life Science USA tracker
Sponsor
HALO Diagnostics
Phase
Observational
Started
2016-05
Last updated
2022-03-25

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

MR-guided laser focal therapy

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

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.

Eligibility

Sex
MALE
Min age
45 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: Treatment Naïve patients: * Male, 45 years of age or older. * Diagnosis of prostate adenocarcinoma. * Clinical stage T1c or T2a. * Gleason score of 7 (3+4 or 4+3) or less. * Three or fewer biopsy cores with prostate cancer. * PSA density not exceeding 0.375. * One, two, or three tumor suspicious regions identified on multiparametric MRI. * Negative radiographic indication of extra-capsular extent. * Karnofsky performance status of at least 70. * Estimated survival of 5 years or greater, as determined by treating physician. * Tolerance for anesthesia/sedation. * Ability to give informed consent. * At least 6 weeks since any previous prostate biopsy. * MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less. Salvage candidates will be accepted upon physician referral. Exclusion Criteria: * Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI. * Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater * History of other primary non-skin malignancy within previous three years. * Diabetes * Smoker

Primary outcome measure(s)

  • Safety and adverse events — 1 yr. post treatment
    Number of subjects reporting serious adverse events.

Trial sites (1)

FacilityCityRegionStatus
Desert Medical Imaging Indian Wells California

More HALO Diagnostics trials in the USA

Phase I Human Analytics (HALO) Study Recruiting

Other trials for the same condition

A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation Recruiting
A Randomised Controlled Trial to Evaluate the Impact of Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life Active, not recruiting
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors Active, not recruiting
Stratagen Quantitative Prostate MRI Platform Pilot Study Active, not recruiting
dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02243033 on ClinicalTrials.gov ↗ ← All trials in the USA