Protocol Details
Magnetic Resonance Image (MRI) Guided High Energy Ultrasound for Focal Prostate Cancer Ablation
This study is currently recruiting participants.
Summary
Number |
21-C-0017 |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male
Min Age: 18 Years
Max Age: N/A |
Referral Letter Required |
No |
Population Exclusion(s) |
Female;
Children |
Keywords |
TULSA;
Thermal Therapy System;
PSA;
Gleason Score |
Recruitment Keyword(s) |
None |
Condition(s) |
Prostate Cancer |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Device: TULSA-PRO
|
Supporting Site |
National Cancer Institute |
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.
Eligibility
INCLUSION CRITERIA:
Subjects must have prostate cancer amenable for ultrasound ablation defined as:
- diagnosed by transrectal ultrasound-guided prostate biopsy via standard 12 core biopsy and targeted biopsy of any MRI-visible or tracked lesions; pathological diagnosis must be confirmed by Laboratory of Pathology, NCI;
- Gleason Score <= 7;
- MRI-visible or MRI-tracked prostate cancer. This includes prostate cancer found on targeted biopsy of MRI-visible or MRI-tracked lesion. Histologically positive standard biopsy cores of Grade Group >= 2 prostate cancer must be from an area overlying or within 1cm of an MRI-visible or tracked lesion(s) and reviewed by NCI urologic pathologist. (Left / Right, Base, Mid-Gland, Apex). Systematic and targeted cores of Grade Group 1 prostate cancer outside of proposed ablation zone do not affect inclusion status, as these can be observed by conventional guideline management.
- organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI. Note: Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI are eligible.
- PSA < 20 ng/ml or PSA >20 with a PSA density <0.15.
- Adults (>= 18 years of age)
- Participants must have adequate organ and marrow function as defined below:
Platelets >= 50,000/mcL
Hemoglobin >= 8 g/dL
Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)* >= 30 mL/min/1.73 m^2
GFR=glomerular filtration rate; ULN=upper limit of normal.
*Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.
- Subjects must be able to understand and willing to sign a written informed consent document.
- Subjects must be co-enrolled to NCI protocol 16-C-0010 "Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue."
EXCLUSION CRITERIA:
- Targeted lesion ablation length from apex to base of >5 cm or lesion extending >3 cm from the urethra.
- Target ablation volume greater than 100 ml.
- Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target.
- Participants are unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc.)
- Acute urinary tract infection
- Lower urinary tract symptoms defined by an IPSS > 20
- Participants with uncontrolled coagulopathies (including liver dysfunction, or untreated hereditary coagulopathies which have a standard of care treatment) per surgeon discretion based on bleeding risk.
- 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 situation (within time frame) that would limit compliance with study requirements.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT04808427