NCT02224911

Brief Summary

This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as well as to gather data for the design of future studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 21, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

September 11, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2019

Completed
Last Updated

July 27, 2020

Status Verified

February 1, 2020

Enrollment Period

5.1 years

First QC Date

July 21, 2014

Last Update Submit

July 23, 2020

Conditions

Prostate Cancer

Keywords

focal therapyprostate cancer treatmentlaser treatment

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability

    12 months

Secondary Outcomes (1)

  • Absence of prostate cancer in the MRI target area as measure of efficacy.

    12 months

Study Arms (1)

Laser Interstitial Thermal Therapy

This is a minimally invasive procedure for focal treatment of prostate cancer.

Device: Laser Interstitial Thermal Therapy

Interventions

Laser Interstitial Thermal TherapyDEVICE
Laser Interstitial Thermal Therapy

Eligibility Criteria

Age40 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men, 40 to 85 years of age, recently diagnosed with prostate cancer using the MRI fusion technology.

You may qualify if:

  • Subjects with initial presentation of organ confined prostate cancer (clinical stage ≤ T2b)
  • 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
  • ROI located proximal to the external sphincter by a margin of at least 2 cm
  • 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 (≥ 2 cores)
  • Overall Gleason score not to exceed 3+4
  • Subjects desire focal therapy and declined conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
  • Signed informed consent for the LITT 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 (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (2)

  • Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.

    PMID: 23335087BACKGROUND

  • Carter HB, Kettermann A, Warlick C, Metter EJ, Landis P, Walsh PC, Epstein JI. Expectant management of prostate cancer with curative intent: an update of the Johns Hopkins experience. J Urol. 2007 Dec;178(6):2359-64; discussion 2364-5. doi: 10.1016/j.juro.2007.08.039. Epub 2007 Oct 22.

    PMID: 17936806BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pantuck Alan, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Steven Raman, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2014

First Posted

August 25, 2014

Study Start

September 11, 2014

Primary Completion

October 21, 2019

Study Completion

October 21, 2019

Last Updated

July 27, 2020

Record last verified: 2020-02

Locations

US(1)