Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04808427|
Recruitment Status : Not yet recruiting
First Posted : March 22, 2021
Last Update Posted : September 23, 2022
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.
To understand if Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance is useful to treat localized prostate cancer.
English-speaking adults ages 18 and older with localized prostate cancer that can be seen on MRI and can be treated by thermal ablation.
Participants will be screened with the following:
- Medical history
- Physical exam
- Digital rectal exam
- Blood and urine tests
- 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:
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: TULSA-PRO||Not Applicable|
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.
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)
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
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Magnetic Resonance Image (MRI) Guided High Energy Ultrasound for Focal Prostate Cancer Ablation|
|Estimated Study Start Date :||September 28, 2022|
|Estimated Primary Completion Date :||May 1, 2027|
|Estimated Study Completion Date :||September 1, 2027|
Experimental: 1/Arm 1
Ultrasound ablation of focal prostate cancer
Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate
- 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)
- 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
- 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
- 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
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04808427
|Contact: Michele L Reed (Diffenderfer), R.N.||(240) firstname.lastname@example.org|
|Contact: Peter A Pinto, M.D.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Peter A Pinto, M.D.||National Cancer Institute (NCI)|