Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer

Completed

• Conditions: Prostate Cancer
• Interventions: Device: Laser Interstitial Thermal Therapy

• Registration Number: NCT02224911
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-25
• Study Start: 2014-09-11
• Primary Completion: 2019-10-21
• Study Completion: 2019-10-21
• Status Verified: 2020-02
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Prior prostate, bladder neck, or urethral stricture surgery

  • Any prostate debulking procedure, including: transurethral resection of prostate, photovaporization, or electrovaporization
  • Transurethral incision of bladder neck
  • Urethral stricture dilation or reconstruction

• Any current 5-alpha reductase inhibitors (history of use ≥ 6 months prior to MRI is acceptable)

• Prior significant rectal surgery (hemorrhoidectomy is acceptable)

• Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device

• History of inflammatory bowel disease

• Urinary tract or rectal fistula

• Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible prosthesis)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laser Interstitial Thermal Therapy	Laser Interstitial Thermal Therapy	This is a minimally invasive procedure for focal treatment of prostate cancer.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability	12 months

Secondary Outcome Measures

Name	Time	Method
Absence of prostate cancer in the MRI target area as measure of efficacy.	12 months

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States