A prospective, multi-center, single arm study – Evaluation of the safety and feasibility of MRI-guided transurethral ultrasound therapy for the ablation of prostate tissue in patients with localized prostate cancer
- Conditions
- Prostate CancerC61Malignant neoplasm of prostate
- Registration Number
- DRKS00005311
- Lead Sponsor
- Profound Medical Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 30
1.Male, age = 65 years
2.Patient with low-risk, early-stage organ-confined prostate cancer (Clinical stage T1c or T2a, N0, M0).
3.Gleason score 6 (3+3) or max 7 (3+4)
4.PSA = 10 ng/ml
5.Eligible for MR imaging (DOC-10252)
6.Meets the following criteria on pre-treatment transrectal ultrasound imaging:
•No cysts or calcifications > 1.0 cm in size
•No evidence of extraprostatic extension or seminal vesicle invasion
•Overall prostate size less than 5 cm in sagittal length and less than 6 cm in diameter
7.Biopsy confirmed adenocarcinoma of the prostate: performed at least 6 weeks prior to and preferably no more than 6 months prior to the scheduled treatment, or at the discretion of the PI.
8.Eligible for General Anesthesia, as defined in American Society of Anesthesiologists (ASA)
9.Normal rectal anatomy and rectal mucosa on digital rectal examination
1.Bleeding disorder (International Normalized Ratio (INR) > ULN and partial thromboplastin time (PTT) > ULN)
2.Abnormal coagulation and current anticoagulant therapy. (Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment delivery are eligible.)
3.Acute or chronic Urinary Tract Infection (UTI)
4.Interest in future fertility
5.History of allergy to latex and any relevant medication
6.History of any other malignancy other than skin cancer within the previous 5 years. Patients that have had a previous malignancy and no recurrence of that malignancy within the past 5 years will be allowed.
7.Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e. claudication of the buttocks or perineum)
8.Prior treatment of the prostate gland, including but not limited to radiation therapy (external beam or brachytherapy), high intensity focused ultrasound, thermal therapy, androgen deprivation therapy, bilateral orchiectomy, transurethral needle ablation of the prostate and transurethral resection of the prostate.
9.Prior treatment with 5 alpha reductase inhibitor allowed provided it was for benign prostatic hypertrophy (not as prostate cancer treatment or prevention) and as long as drug has been stopped for approximately 6 months and if less, clinical justification must be provided.
10.History of any major rectal or pelvic surgery
11.History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis, hemorrhoids)
12.History of documented clinical prostatitis requiring therapy within previous 6 months
13.History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae which had required prior urethrotomy, urethral stenting, urethroplasty or chronic indwelling urethral catheter
14.Patients with artificial urinary sphincter or any penile implant (metallic or non-metallic)
15.Neurologic bladder disorders
16.Untreated bladder stones
17.History of acute urinary retention
18.Confirmed or suspected bladder cancer
19.Urinary sphincter abnormalities
20.Active untreated gross hematuria for any cause
21.Post Void Residual (PVR) bladder volume > 250 mL
22.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.
23.Received any prostate related investigational treatment within 12 months of Visit 1
24.Undergone major surgery/surgical therapy unrelated to prostate and adjacent organs must have sufficient healing period (discretion of the investigator) prior to the Baseline visit
25.Prior pelvic radiotherapy
26.Any of the following within the 6 months prior to Visit 1: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (NYHA Class III or IV), cerebrovascular accident, transient ischemic attack, pulmonary embolism, sustained ventricular tachycardia, clinically significant bradycardia, ventricular fibrillation, or advanced heart block
27.Ongoing cardiac dysrhythmias = grade II (NCI CTCAE v4.0)
28.History of Parkinson’s disease or multiple sclerosis
29.History of alcohol or drug abuse
30.Treatment with antidepressant drugs which in the judgment of the investigator would make the patient inappropriate for entry i
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the frequency and severity of device / treatment related adverse events associated with the use of the TULSA-PRO system to coagulate prostate tissue.<br>•Severity of adverse events per patient will be evaluated (from the treatment date to the 12-month follow-up date ) and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).<br>
- Secondary Outcome Measures
Name Time Method