Fusion Guided Focal Laser Ablation of Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02759744|
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2016
Last Update Posted : March 21, 2018
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).
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.
Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body.
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Neoplasms||Device: ultrasound image-guided ablation device||Phase 3|
- 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.
- 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.
- 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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Ultrasound Guided Focal Thermal Ablation of Prostate Cancer|
|Study Start Date :||April 22, 2016|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
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
- 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 [ Time Frame: duration of protocol ]Assessment of thermal damage outside of intended treatment areas as measured by post contrast MRI, and the frequency of other adverse events and complications.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759744
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Bradford Wood, M.D.||National Institutes of Health Clinical Center (CC)|