Clinical trial NCT02224911: Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer
Official title: Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer: A Pilot Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: focal therapy
prostate cancer treatment
laser treatment
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 8
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men, 40 to 85 years of age, recently diagnosed with prostate cancer using the MRI fusion technology.

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 gather data for the design of future studies.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 12 months
Secondary outcomes:
measure: Absence of prostate cancer in the MRI target area as measure of efficacy.
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Pantuck Alan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Steven Raman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
citation: Carter HB, Kettermann A, Warlick C, Metter EJ, Landis P, Walsh PC, Epstein JI. Expectant management of prostate cancer with curative intent: an update of the Johns Hopkins experience. J Urol. 2007 Dec;178(6):2359-64; discussion 2364-5. doi: 10.1016/j.juro.2007.08.039. Epub 2007 Oct 22.