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Trial record 1 of 23 for:    cancer | Studies received from 04/22/2016 to 04/22/2016
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Fusion Guided Focal Laser Ablation of Prostate Cancer

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 25, 2017 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT02759744
First received: April 22, 2016
Last updated: June 1, 2017
Last verified: May 25, 2017
  Purpose

Background:

Prostate cancer is the most common non-skin cancer in U.S. men. Treatments for early or less aggressive disease are limited. Researchers want to test a device that destroys cancerous tissue with laser energy. They want to see if using it with ultrasound is more comfortable than using it with magnetic resonance imaging (MRI).

Objectives:

To test a cooled laser applicator system to treat prostate cancer lesions. To see if ultrasound imaging is a practical and feasible treatment with laser ablation for focal prostate cancer treatment.

Eligibility:

Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body.

Design:

Participants will be screened with standard cancer care tests. These can include physical exam, lab tests, and MRI. For the MRI, they lie in a machine that takes pictures. Participants will have a prostate biopsy. Needle samples will be taken from 12 places in the prostate. This will be guided by MRI and ultrasound, which is obtained through a coil in the rectum.

Participants will stay at the clinic for 1 2 days. A cooling catheter (plastic tube) will be put in the bladder. Ultrasound will guide the laser applicator directly to the tumor.

The cooling catheter will be removed. A different catheter will be put in the urethra to keep the bladder emptied.

The next day, participants will have a physical exam and a PSA blood test.

Participants will have 6 follow-up visits over 3 years. At each visit, they will have a physical exam and lab tests. At some visits, they will also have an MRI or other scans and a prostate biopsy.


Condition Intervention Phase
Prostate Cancer Prostate Neoplasms Device: ultrasound image-guided ablation device Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Pilot Study of Ultrasound Guided Focal Thermal Ablation of Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To determine the feasibility of treating biopsy-confirmed and MRvisible, low-grade prostate tumor(s) using ultrasound (US) image-guided focal interstitial thermal ablation [ Time Frame: duration of protocol ]

Secondary Outcome Measures:
  • To determine changes in imaging and biopsy characteristics after thermal ablation of localized prostate cancer. [ Time Frame: 3 years after treatment completed ]
  • To analyze circulating tumor markers and functional markers inindividuals with prostate cancer after receiving treatment over time [ Time Frame: 2 weeks after the ablation ]

Estimated Enrollment: 30
Study Start Date: April 15, 2016
Estimated Study Completion Date: January 1, 2020
Estimated Primary Completion Date: January 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ultrasound image-guided focal laser ablation (FLA)
Device: ultrasound image-guided ablation device
ultrasound image-guided focal ablation - may be either laser ablation or cryotherapy

Detailed Description:

Background:

  • Pilot study to evaluate the feasibility of real time ultrasound imaging to guide focal thermal ablation of low risk focal prostate tumors
  • Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years.
  • Some prostate cancers prove to be small, low grade, and noninvasive and they appear to pose little risk to life or health. Recent patient series suggest that 20% to 30% of men undergoing radical prostatectomy have pathologic features in the radical prostatectomy

specimen consistent with an insignificant or "indolent" cancer that poses little threat to life or health.

  • An NIH/NCI protocol #11-C-0158 titled MR Image guided focal laser ablation therapy of prostate cancer has treated 15 patients without major complication over the past 5 years. Out of 15 patients, 3 have had evidence of disease recurrence. This data is being prepared for publication (verbal communication with Peter Pinto, MD, principal investigator); however, it requires a very long and resource-intensive MRI imaging, which may be a barrier to broad translation to the community setting. Specialized custom and expensive MRI-compatible equipment is also required. Focal laser ablation for prostate cancer using the Medtronic-Visualase laser is FDA cleared.
  • Focal thermal ablation such as laser ablation or cryosurgery are standard of care therapies for prostate cancer, with cancer control comparable to that of external beam radiotherapy and brachytherapy.
  • NIH / NCI clinical trials have performed MRI + ultrasound (US) fusion biopsy in nearly 1500 patients, greater than 30,000 biopsies over the past 12 years.
  • We propose to perform ultrasound (US) guided focal thermal ablation with fusion visualization and co-display of pre-acquired MRI during the treatment of patients with low volume and low-grade disease.

Objectives:

- To determine the feasibility of treating biopsy-confirmed and MR-visible, low-grade prostate tumor(s) using ultrasound (US) image-guided focal interstitial thermal ablation.

Eligibility:

  • Patients must have localized, low-volume, non-aggressive, low risk prostate cancer that is MR visible and confirmed by needle biopsy.
  • Tumor must be confined within the prostate.
  • PSA less than 15 ng/ml, or PSA density (PSA/prostate volume) less than 0.15 ng/mL2 in patients with a PSA greater than15 ng/mL
  • Men greater than or equal to 18 years of age.
  • Preoperative clearance by NIH Department of Anesthesia and Surgical Services.
  • No evidence of metastatic disease per NCCN guidelines

Design:

  • Pilot study, testing feasibility of ultrasound-guided thermal ablation of focal prostate cancer.
  • A total of 30 patients will be enrolled to yield 20 evaluable patients.
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Enrollment open only to current NIH patients enrolled in 16-C-0010.
  • Patients must have clinically localized, low-volume, non-aggressive, low risk cancer: Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging.

    • T1c Tumor identified by needle biopsy (e.g., because of elevated PSA)
    • T2a Tumor confined within prostate
  • Prostate cancer is diagnosed by transrectal or transperineal ultrasound guided standard 12 core biopsy or MR image guided biopsy, or MR / US fusion guided biopsies. There may be up to 2 focal targets that are well-defined by imaging as verified by at least 2

radiologists.

  • Gleason Score less than or equal to 7
  • Targeted tumors must be considered a safe distance from the urethra, rectal wall, or neurovascular bundle by the Principal Investigator.
  • Must have had a prostate MRI performed at the NIH within 12 months prior to enrollment.
  • Must have had a prostate biopsy performed at NIH within 12 months prior to enrollment.
  • No evidence of metastatic disease per NCCN guidelines version 1.2016 Prostate Cancer
  • PSA less than 15 ng/ml, or PSA density (PSA/prostate volume) less than 0.15 ng/mL^2 in patients with a PSA greater than 15 ng/mL
  • Men greater than or equal to 18 years of age.
  • ECOG performance status less than or equal to 2
  • Patients must have normal organ and marrow function as defined below:

    • leukocytes greater than or equal to 3,000/mcL
    • absolute neutrophil count greater than or equal to 1,500/mcL
    • platelets greater than 100,000/mcL
    • total bilirubin within normal institutional limits
    • AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
    • creatinine within normal institutional limits

OR

  • creatinine clearance greater than or equal to 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.

    • Preoperative clearance by NIH Department of Anesthesia and Surgical Services
    • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Subject understands that this is an experimental treatment and that there are available standard treatment options. These options would include but not be limited to: active surveillance, external beam radiation and brachytherapy, androgen deprivation therapy,

or prostatectomy.

EXCLUSION CRITERIA:

  • Presence of extra capsular, seminal vesical invasion or metastatic disease per NCCN guidelines (www.nccn.org). Bone scan indicated to rule out metastatic disease if [clinical T1 and PSA greater than 20 or T2 and PSA less than 10].
  • Patient unable to commit to follow up.
  • History of prior treatment for prostate cancer.
  • Acute urinary tract infection.
  • Patients with uncontrolled coagulopathies.
  • Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes.
  • Other serious illnesses according to the PI: involving the cardiac, respiratory, CNS, renal or hepatic organ systems, that would preclude study completion or increase risks of local therapies above an acceptable level.
  • Inability to undergo a contrast enhanced MRI per American College of Radiology and the Clinical Center, Department of Radiology guidelines.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the Principal Investigator, would limit compliance with study requirements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02759744

Contacts
Contact: Charisse Garcia, R.N. (301) 594-4511 garciacr@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Principal Investigator: Bradford Wood, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02759744     History of Changes
Other Study ID Numbers: 160098
16-CC-0098
Study First Received: April 22, 2016
Last Updated: June 1, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Thermal Ablation
Localized Prostate Cancer
Medtronic-Visualase
Thermal Damage
PSA Levels

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 23, 2017