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A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.
Full description
Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system (TULSA-PRO). The technology is developed for patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.
The treatment is conducted within a MRI suite, which enables real-time temperature images of the heated region to be acquired as the ultrasonic treatment is delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the pattern of thermal coagulation accurately and precisely in the prostate gland.
It provides advantages of a non-invasive procedure with short treatment times.
Enrollment
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Inclusion criteria
4.1 Gleason score ≤ 3 + 4 (Part I only)
4.2 Gleason score 3+4 (Part II only) *now recruiting
PSA ≤ 15 ng/ml
Eligible for MRI [Form GCP-10131]
Eligible for general anesthesia (ASA category ≤ 3)
Prostate volume ≤ 90 cc, on Baseline MRI
Prostate size ≤ 5.0 cm in sagittal length, and ≤ 6.0 cm in axial diameter, on Baseline MRI
Life expectancy ≥ 10 years
No calcifications in the planned ultrasound beam path, or at the discretion of the investigator with approval from the Sponsor.
Exclusion criteria
Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
Prior definitive treatment of prostate cancer
Prior transurethral resection of the prostate (TURP)
Use of 5-alpha reductase inhibitors (5-ARIs) or hormone therapy within 3 months prior to the baseline visit. Baseline PSA must be established after a minimum of 3 months following 5-ARIs discontinuation. Additionally, use of 5-ARIs is not permitted following treatment during the study follow-up period.
Prostate calcifications > 1 cm in largest diameter, on Baseline Ultrasound
Cysts > 1 cm in largest diameter, on Baseline MRI
Bleeding disorder (INR > ULN and PTT > ULN)
Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria.
Acute unresolved Urinary Tract Infection (UTI)
Interest in future fertility
History of any other malignancy other than skin cancer, or low grade bladder cancer which has been completely resected, within the previous 2 years. Patients that have had curative treatment of a previous malignancy and no recurrence of that malignancy within the past 2 years will be allowed.
Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
Patients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c > 7%.
History of any major rectal or pelvic surgery or radiotherapy
History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis)
Documented clinical prostatitis requiring therapy within 6 months prior to Treatment
History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae, urethral stenting, urethral sling, urethroplasty or chronic indwelling urethral catheter
Patients with artificial urinary sphincter or any penile implant
Severe neurogenic bladder
Untreated bladder stones
History of acute urinary retention within the last 12 months
Active untreated gross hematuria for any cause
Post Void Residual (PVR) bladder volume > 250 mL
Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder, sometimes referred to as "ball valve" median lobe, determined on Baseline MRI
Any prostate related investigational therapy within 6 months of Visit 1
History of Parkinson's disease or multiple sclerosis
History of drug abuse
Known infectious disease including HIV positivity or AIDS-related illness, HBV and HCV
Current unilateral or bilateral hydronephrosis
Allergy or contraindications to administration of the GI anti-spasmodic drug:
Contraindications to administration of gadolinium-based MRI contrast agent (e.g. Magnevist), such as chronic, severe kidney disease, acute kidney injury, history of Sickle Cell Disease, history of anemia, or intolerance/allergy to the contrast agent
Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results
Primary purpose
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Interventional model
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150 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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