This study is NOT currently recruiting participants.
Number
16-CC-0098
Sponsoring Institute
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Clinical hold/Recruitment or enrollment suspended Gender: Male Min Age: 18 Years Max Age: 100 Years
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)
Investigational Device(s)
Intervention(s)
Device: ultrasound image-guided ablation device
Supporting Site
NIH Clinical Center
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.
--Back to Top--
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.
- 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.
Principal Investigator
Referral Contact
For more information: