NCT02357121

Brief Summary

This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue and to gather data for the design of future studies. Intra-procedure temperature and concurrent rectal wall thermistor monitoring will be performed for internal validation. Subjects will be monitored for adverse events, and health-related quality of life (HRQOL) questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to evaluate histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also be monitored.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at P25-P50 for early_phase_1 prostate-cancer

Timeline
Completed

Started Sep 2015

Typical duration for early_phase_1 prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

September 17, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
Last Updated

September 21, 2020

Status Verified

April 1, 2020

Enrollment Period

3.9 years

First QC Date

January 28, 2015

Last Update Submit

September 17, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • safety of focal laser treatment using LITT: Number of participants with adverse events

    Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.

    12 months

Secondary Outcomes (1)

  • Efficacy of focal laser ablation of prostate tissue using the LITT system.

    12 months

Study Arms (1)

Laser ablation

EXPERIMENTAL

All patient will undergo focal ablation of prostate tissue utilizing laser energy.

Device: Focal Laser Ablation

Interventions

Focal Laser AblationDEVICE

Focal laser ablation of prostate tissue using laser interstitial thermal therapy (LITT) under MR/ultrasound fusion guidance

Also known as: laser treatment
Laser ablation

Eligibility Criteria

Age40 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with untreated organ confined prostate cancer (clinical stage ≤ T2b, Gleason ≤ 3+4)
  • Negative metastatic workup with bone scan and CT abdomen/pelvis, within 6 months of study treatment, if indicated by PSA \>10
  • Age 40 years to 85 years of age
  • Multi-parametric MRI at UCLA within 6 months of study treatment, demonstrating a
  • Region of interest (ROI) of MRI suspicion level 3 or higher
  • MRI-calculated prostate volume 25cc to 100cc
  • Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 MRI-ultrasound fusion targeted biopsy cores from above MRI-derived ROI
  • Histologically-confirmed adenocarcinoma from targeted biopsy cores
  • Overall Gleason score not to exceed 3+4
  • Subjects desire focal therapy and decline conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
  • Signed informed consent for the FLA treatment through the 12 month follow up visit.

You may not qualify if:

  • Any significant cancer outside of MRI target (ROI) area, defined as Gleason score \> 3+4
  • \< 10 years life expectancy
  • American Society of Anesthesiologists (ASA) criteria of IV or higher
  • Unfit for conscious sedation anesthesia
  • Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, INR or platelet count (as determined by institutional lab parameters) at the time of screening
  • Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
  • Active urinary tract infection
  • Prostate abscess, chronic or acute prostatitis, or neurogenic bladder
  • Any prior treatment for prostate cancer
  • Radical prostatectomy
  • Radiation therapy (external beam or brachytherapy)
  • Cryotherapy
  • High intensity focused ultrasound treatment
  • Photodynamic therapy
  • Androgen deprivation therapy
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA

Los Angeles, California, 90095, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Leonard Marks, MD

    University of California at Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 6, 2015

Study Start

September 17, 2015

Primary Completion

August 20, 2019

Study Completion

August 20, 2019

Last Updated

September 21, 2020

Record last verified: 2020-04

Locations

US(2)