MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer

NCT01792024 | Completed Results

• 3 other identifiers: 12-1841NCI-2013-00404R21CA173751
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer

Conditions

Stage I Prostate Cancer; Stage II Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment

  The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.

  At 3 months after ablation

Secondary Outcomes (4)

• The Number of Patients With Biopsy Cancer of the Treatment Zone

  At 12 months

• The Total Number of Patients With Any Adverse Events Related to the Treatment

  1,3, and 12 month after treatment and up to 12 months

• Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)

  At 1,3 and 12 months

• Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)

  At 1,3 and 12 months

Study Arms (1)

Treatment (LITT)

EXPERIMENTAL

Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.

Device: Visualase Thermal Therapy; Procedure: magnetic resonance imaging

Interventions

Visualase Thermal Therapy DEVICE

MR guided laser ablation of prostate cancer

Also known as: laser interstitial thermal therapy

Treatment (LITT)

magnetic resonance imaging PROCEDURE

Undergo MR-guided LITT

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Treatment (LITT)

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical characteristics:
• Stage T1c or T2a
• Prostate-specific antigen (PSA) \< 15 ng/ml or PSA density (PSA divided by prostate volume in cubic centimeters) \< 0.15 ng/ml\^3
• No evidence of metastatic disease based on National Comprehensive Cancer Network (NCCN) guidelines:
• Bone scan if PSA \> 20 ng/ml and clinical stage T1c
• Bone scan if PSA \> 10 ng/ml and clinical stage T2
• Biopsy requirements:
• Gleason score 7 or less
• % or fewer biopsies with cancer
• At least 12 biopsy cores of the prostate
• Within 12 months of treatment
• Imaging requirements:
• Up to 2 visible magnetic resonance (MR) lesion(s) concordant with sextant of biopsy-detected cancer(s)
• MRI within 6 months of treatment
• Karnofsky performance status of at least 70

You may not qualify if:

• Previous treatment of prostate cancer with luteinizing hormone releasing hormone (LHRH) agonist/antagonist, chemotherapy, surgery, or radiation
• Presence of 3 or more visible lesions on MRI
• High suspicion of seminal vesicle invasion or lymph node metastases on MRI
• Unable to tolerate MRI (medical device, foreign body, claustrophobia, body habitus, or other)
• Renal insufficiency with estimated glomerular filtration rate (eGFR) \< 30 ml/min/body surface area (BSA) based on Modification in Diet Renal Disease equation; inability to safely receive gadolinium contrast for MRI
• History of prior pelvic surgery with surgical clips remaining in situ (e.g., bladder, bowel, internal pelvic organs) that compromise MRI image quality
• Other serious illnesses involving the cardiac, respiratory, central nervous system (CNS), or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Aytekin Oto
• Organization: University of Chicago

aoto@radiology.bsd.uchicago.edu

773-834-7424

Study Officials

• Aytekin Oto

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Scott Eggener, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: January 28, 2013
• Primary Completion: September 16, 2015
• Study Completion: September 16, 2015
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-02

Locations

US (1)