Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment laser interstitial thermal therapy
Phase phase 2
Sponsor Jonsson Comprehensive Cancer Center
Start date July 2014
End date January 2017
Trial size 8 participants
Trial identifier NCT02224911, 14-000409, LITT Treatment

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
This is a minimally invasive procedure for focal treatment of prostate cancer.
laser interstitial thermal therapy

Primary Outcomes

Measure
Number of participants with adverse events as a measure of safety and tolerability
time frame: 12 months

Secondary Outcomes

Measure
Absence of prostate cancer in the MRI target area as measure of efficacy.
time frame: 12 months

Eligibility Criteria

Male participants from 40 years up to 85 years old.

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)

Additional Information

Official title Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer: A Pilot Feasibility Study
Principal investigator Pantuck Alan, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center.