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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.
Full description
Background:
specimen consistent with an insignificant or "indolent" cancer that poses little threat to life or health.
Objectives:
Eligibility:
Design:
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
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:
OR
creatinine clearance greater than or equal to 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
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:
Primary purpose
Allocation
Interventional model
Masking
14 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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