from the ClinicalTrials.gov record
Background:
The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy. Researchers want to improve on these methods.
Objective:
To understand if Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance is useful to treat localized prostate cancer.
Eligibility:
English-speaking adults ages 18 and older with localized prostate cancer that can be seen on MRI and can be treated by thermal ablation.
Design:
Participants will be screened with the following:
* Medical history
* Physical exam
* Digital rectal exam
* Blood and urine tests
* Electrocardiogram
* Tumor biopsy
* Questionnaire to assess urinary tract symptoms
* MRI of the pelvis. The MRI scanner is a long, narrow tube. Participants will lie on a bed that moves in and out of the scanner.
Participants may also be screened with the following:
* Echocardiogram
* Chest x-ray
* Bone scan
* Urodynamic studies to see how well the bladder, sphincters, and urethra hold and release urine
* MRI of the brain
* Transrectal ultrasound
* Computer tomography (CT) scan of the chest, abdomen, and pelvis. A CT scan is a series of x-ray images taken of parts of the body.
Some screening tests will be repeated during the study.
Participants will have the TULSA procedure. They will have an MRI for guidance. A small ultrasound applicator will be placed into their urethra. It uses heat to destroy the cancer areas in the prostate. It is controlled by a robotic arm. A cooling catheter will be placed into their rectum.
Participants will use a urethral catheter for 1-7 days.
Participants will have follow-up visits at 3, 6, 12, 18, 24, and 36 months.