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.
Additional locations may be listed on ClinicalTrials.gov for NCT04808427.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Active
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937
Background:
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 the life or health of the host. 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
which poses little threat to life or health.
We propose that participants with low volume and low grade disease can be best served
with focal ablation of the visible prostate cancer without the side effects of urinary
incontinence and erectile dysfunction associated with radiation therapy or radical
surgery.
Focal Therapy for prostate cancer has gained popularity however prior studies demonstrate
a failure rate as high as 50% with a laser.
Objective:
To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced
thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA
Thermal Therapy System (Profound Medical)
Eligibility:
Subjects with prostate cancer, amenable for ultrasound ablation
Organ confined clinical T1c or clinical T2a prostate cancer, visible on MRI, and
confirmed by prostate biopsy
Adequate organ and marrow function
Prostate-specific antigen (PSA) < 20 ng/ml
Age >=18 years
Design:
Study testing feasibility and tolerability of ultrasound ablation of focal prostate
cancer.
It is anticipated that 15 participants will be evaluated for this study.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationNational Cancer Institute
Principal InvestigatorPeter A. Pinto
