Focal Laser Ablation of Prostate Tissue

Early Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Device: Focal Laser Ablation

• Registration Number: NCT02357121
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-06
• Study Start: 2015-09-17
• Primary Completion: 2019-08-20
• Study Completion: 2019-08-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

Not provided

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 ≥ 3 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

  • Inflammatory bowel disease

  • Urinary tract or rectal fistula

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser ablation	Focal Laser Ablation	All patient will undergo focal ablation of prostate tissue utilizing laser energy.

Primary Outcome Measures

Name	Time	Method
safety of focal laser treatment using LITT: Number of participants with adverse events	12 months	Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.

Secondary Outcome Measures

Name	Time	Method
Efficacy of focal laser ablation of prostate tissue using the LITT system.	12 months	MRI changes will be determined at 6 and 12 months post FLA to assess efficacy.

Trial Locations

Locations (2)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

UCLA; 🇺🇸 Los Angeles, California, United States