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

NCT ID: NCT02224911

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-11
• Study Completion Date: 2019-10-21

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Laser Interstitial Thermal Therapy

This is a minimally invasive procedure for focal treatment of prostate cancer.

Laser Interstitial Thermal Therapy

Intervention Type: DEVICE

Interventions

Laser Interstitial Thermal Therapy

Intervention Type: DEVICE

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)

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

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pantuck Alan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Steven Raman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23335087 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17936806 (View on PubMed)

Other Identifiers

JCCCID436

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2015-01487

Identifier Type: OTHER

Identifier Source: secondary_id

14-000409

Identifier Type: -

Identifier Source: org_study_id