Prostate Cancer Clinical Trial
Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
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:
Digital rectal exam
Blood and urine tests
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:
Urodynamic studies to see how well the bladder, sphincters, and urethra hold and release urine
MRI of the brain
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.
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.
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.
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.
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There is 1 Location for this study
Bethesda Maryland, 20892, United States More Info
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