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

Completed

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02224911

Run by

Jonsson Comprehensive Cancer Center

People needed

8

Starts

2014-09-11

Expected to finish

2019-10-21

Last updated by the study team

2020-07-27

Who can join

Age: 40 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

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
• 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)

Where it is running

• UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.