Focal Laser Ablation of Prostate Tissue

NCT ID: NCT02357121

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-17
• Study Completion Date: 2019-08-20

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser ablation

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

Group Type: EXPERIMENTAL

Focal Laser Ablation

Intervention Type: DEVICE

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

Interventions

Focal Laser Ablation

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

Intervention Type: DEVICE

Other Intervention Names

laser treatment

Eligibility Criteria

Inclusion Criteria

• 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.

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jean Perkins Foundation

UNKNOWN

Sponsor Role: collaborator

Medtronic

INDUSTRY

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonard Marks, MD

Role: PRINCIPAL_INVESTIGATOR

University of California at Los Angeles

Locations

UCLA

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

JCCCID534

Identifier Type: OTHER

Identifier Source: secondary_id

15-000018

Identifier Type: -

Identifier Source: org_study_id