- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04808427
Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
Magnetic Resonance Image (MRI) Guided High Energy Ultrasound for Focal Prostate Cancer Ablation
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.
Study Overview
Detailed Description
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 accrued for this study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Peter A Pinto, M.D.
- Phone Number: (240) 858-3700
- Email: pp173u@nih.gov
Study Contact Backup
- Name: Jill M Harper, Ph.D.
- Phone Number: (240) 858-7373
- Email: jill.harper@nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
- Phone Number: 888-624-1937
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
- INCLUSION CRITERIA:
Subjects must have prostate cancer, amenable for ultrasound ablation defined as following:
- diagnosed by prostate biopsies consist of transrectal ultrasound-guided standard 12 core biopsy and biopsies of one or two MRI target lesions;
- Gleason Score <= 7;
- <= 4 cores positive in a standard 12 core biopsy and <= 4 cores positive on MRI target lesions biopsy where 2 cores are taken from each of the one or two MRI target lesions;
- histologically positive standard biopsy cores must be from the same location in the prostate as an MRI target lesion(s) and reviewed by NCI urologic pathologist. (Left / Right, Base, Mid-Gland, Apex).
- organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI imaging. Note: Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI are eligible.
- PSA < 20 ng/ml.
- Adults (>= 18 years of age)
- Participants must have adequate organ and marrow function as defined below:
Platelets >= 50,000/mcL
Hemoglobin >= 8 g/dL
ALT or AST <= 5 x ULN
Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)* >= 30 mL/min/1.73 m^2
ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); 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.
EXCLUSION CRITERIA:
- The presence of 3 or more MRI visible lesions positive for prostate cancer on biopsy
- Targeted lesion ablation length from apex to base of >5 cm or lesion extending >3 cm from the urethra.
- Target ablative volume of greater than 100 ml.
- Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target.
- The participant is unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc.)
- The participant with the inability to follow up
- 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.
- Other serious illnesses according to the PI: involving the cardiac, respiratory, CNS, renal, or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1/Arm 1
Ultrasound ablation of focal prostate cancer
|
Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
feasibility and tolerability
Time Frame: 3, 6, 12, 18, 24, and 36 months
|
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)
|
3, 6, 12, 18, 24, and 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety and tolerability
Time Frame: 3, 6, 12, 18, 24, and 36 months
|
Address short- and long-term complication rates of study treatment by tabulating adverse events by grade according to CTCAE, and analyzing and reporting descriptively
|
3, 6, 12, 18, 24, and 36 months
|
changes in imaging and biopsy characteristics
Time Frame: 3, 6, 12, 18, 24, and 36 months
|
Determine if focal ablation of MRI visible, biopsy-confirmed prostate cancer using the TULSA Thermal Therapy System (Profound Medical) platform can successfully ablate targeted prostate cancer lesions in >50% of participants
|
3, 6, 12, 18, 24, and 36 months
|
effect of thermal ablation on short- and long-term complication rates
Time Frame: 3, 6, 12, 18, 24, and 36 months
|
Observe thermal damage on post-contrast MRI which extends into areas of the Rectum or Urethra; assess frequency of not completing the procedure
|
3, 6, 12, 18, 24, and 36 months
|
thermal damage
Time Frame: 3, 6, 12, 18, 24, and 36 months
|
Observe thermal damage on post-contrast MRI which extends into areas of the Rectum or Urethra; assess frequency of not completing the procedure
|
3, 6, 12, 18, 24, and 36 months
|
outcome of TULSA ablation
Time Frame: 3, 6, 12, 18, 24, and 36 months
|
Use descriptive statistical analysis to examine serial PSA, PSA density, changes in imaging and biopsy, International Prostate Symptom Score (IPSS), and Sexual Health Inventory for Men (SHIM)
|
3, 6, 12, 18, 24, and 36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter A Pinto, M.D., National Cancer Institute (NCI)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 210017
- 21-C-0017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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