Status:
COMPLETED
Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
40-85 years
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 gat...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 11 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 21 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02224911
Start Date
September 11 2014
End Date
October 21 2019
Last Update
July 27 2020
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90095