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Protocol Details

Pilot Study of Ultrasound Guided Focal Thermal Ablation of Prostate Cancer

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-CC-0098

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children;
Female

Keywords

Thermal Ablation;
Localized Prostate Cancer;
Medtronic-Visualase;
Thermal Damage;
PSA Levels

Recruitment Keyword(s)

None

Condition(s)

Prostate Cancer;
Prostate Neoplasms

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: ultrasound image-guided ablation device

Supporting Site

NIH Clinical Center

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.

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Eligibility

INCLUSION CRITERIA:

- Enrollment open only to current NIH patients enrolled in 16-C-0010.

- Patients must have clinically localized, non-aggressive, low to favorable intermediate risk prostate cancer as defined per current NCCN guidelines (i.e, including review and determination of pathology and tumor characteristics, Gleason Score, PSA levels, and other assessments as clinically appropriate)

-Organ confined clinical prostate cancer hat is US-targetable and/ or visualized on MRI-- T1c Tumor identified by needle biopsy (e.g., because of elevated PSA)

- Prostate cancer diagnosed by transrectal or transperineal US guided standard 12 core needle biopsy or MR image guided needle biopsy, or MR / US fusion guided needle biopsies.

radiologists.

- 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 (+2 months) prior to enrollment.

- Men greater than or equal to 18 years of age.

- ECOG performance status less than or equal to 2

- Patients must have adequate 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 75,000/mcL

--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 protocol 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:

- Patient unable to commit to follow up.

- 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.

- A serious acute or chronic illness that is determined by the PI to place the patient at unreasonable risk for anesthesia and the procedure.

- 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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Bradford J. Wood, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 1C341
10 CENTER DR
BETHESDA MD 20892
(301) 496-7739
bwood@mail.cc.nih.gov

Charisse Garcia, R.N.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1C364
10 Center Drive
Bethesda, Maryland 20892
(301) 594-4511
garciacr@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02759744

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