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Health Condition(s) or Problem
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Localized Low-Risk Prostate Cancer
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Lay Summary
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The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has
the potential to be a safe and effective non-invasive treatment for low risk, organ-confined
prostate cancer involving low incidence of morbidity. The study hypothesis will be tested by
measuring treatment-related safety and initial effectiveness parameters in the ExAblate
MRgFUS treated patients, as described above.
Based on the result of this study, InSightec will initiate a larger study in an effort to
approve low risk, organ-confined prostate cancer as an indication for its ExAblate MRgFUS
device.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
1. Patient of age between 50 to 75 years, inclusive.
2. Biopsy confirmed adenocarcinoma of the prostate, performed up to 6 months prior to
scheduled treatment.
3. Patient with low-risk, early-stage organ-confined prostate cancer (cT1c and cT2a, N0,
M0), diagnosed with TRUS guided transperineal biopsy (TPBx) and voluntarily chooses
MRgFUS as the non-invasive treatment, who may currently be on watchful waiting or
active surveillance and not in need of imminent radical therapy.
4. Patient with PSA less than or equal to 10 ng/mL
5. Gleason score 6 (3+3) or less (no 4 or 5 grades), based on TRUS guided Transperineal
Mapping Biopsy, as defined in the protocol.
6. Up to two (2) cancerous lesions may be identified in the prostate; each tumor is not
more than 10 mm in maximal linear dimension; each tumor should comply with the
maximal 3+3 Gleason score requirement.
7. Positive TRUS-guided transperineal biopsy (TPBx) cores, detected in a maximum of four
(4) sectors, (2 for each cancerous focus) out of 16 sectors (or out of 12 sectors in
prostates with volume <20 cc)
8. Low grade tumors may or may not be visible by multi-parametric MRI. Thus, in case of
MRI-visible tumor, tumor should be in capsular contact of less than 5 mm, on axial
images.
9. No definite evidence of extracapsular extension or seminal invasion by MRI
10. Patient eligible for epidural anesthesia, and general anesthesia (in case of
complication, requiring intervention).
11. Patient is willing and able to give consent and attend all study visits as defined in
the protocol
12. Prostate gland volume should be no greater than 70 cc, volumetrically measured.
Exclusion Criteria:
1. ASA status > 2
2. Contraindications to MRI 2.1. Claustrophobia 2.2. Implanted ferromagnetic materials
or foreign objects 2.3. Known intolerance to the MRI contrast agent (e.g. Gadolinium
or Magnevist) 2.4. Known contraindication to utilization of MRI contrast agent
3. Severely abnormal coagulation (INR>1.5)
4. Patient with unstable cardiac status including:
4.1. Unstable angina pectoris on medication 4.2. Documented myocardial infarction
within 40 days prior to enrolment 4.3. Congestive heart failure NYHA class IV 4.4.
Unstable arrhythmia status, already on anti-arrhythmic drugs
5. Severe hypertension (diastolic BP > 100 on medication)
6. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
7. History of orchiectomy, PCa-specific chemotherapy, cryotherapy, Photodynamic therapy
or radical prostatectomy for treatment of prostate cancer; any prior radiation
therapy to the pelvis for prostate cancer or any other malignancy.
8. Patient under medications that can affect PSA for the last 3 months prior to MRgFUS
treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
9. Individuals who are not able or willing to tolerate the required prolonged stationary
supine position during treatment (approximately 3 hrs.)
10. Any rectal pathology, anomaly or previous treatment, which can change acoustic
properties of rectal wall or prevent safe probe insertion (e.g., fistula, stenosis,
fibrosis).
11. Any spinal pathology which can prevent safe administration of epidural anesthesia
12. Identified calcification of 2 mm or more in largest diameter neighboring the rectal
wall (in a distance of less than 5 mm) and interfering with the acoustic beam path.
13. Lower limb musc
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Who cannot enter the trial
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Inclusion Criteria:
1. Patient of age between 50 to 75 years, inclusive.
2. Biopsy confirmed adenocarcinoma of the prostate, performed up to 6 months prior to
scheduled treatment.
3. Patient with low-risk, early-stage organ-confined prostate cancer (cT1c and cT2a, N0,
M0), diagnosed with TRUS guided transperineal biopsy (TPBx) and voluntarily chooses
MRgFUS as the non-invasive treatment, who may currently be on watchful waiting or
active surveillance and not in need of imminent radical therapy.
4. Patient with PSA less than or equal to 10 ng/mL
5. Gleason score 6 (3+3) or less (no 4 or 5 grades), based on TRUS guided Transperineal
Mapping Biopsy, as defined in the protocol.
6. Up to two (2) cancerous lesions may be identified in the prostate; each tumor is not
more than 10 mm in maximal linear dimension; each tumor should comply with the
maximal 3+3 Gleason score requirement.
7. Positive TRUS-guided transperineal biopsy (TPBx) cores, detected in a maximum of four
(4) sectors, (2 for each cancerous focus) out of 16 sectors (or out of 12 sectors in
prostates with volume <20 cc)
8. Low grade tumors may or may not be visible by multi-parametric MRI. Thus, in case of
MRI-visible tumor, tumor should be in capsular contact of less than 5 mm, on axial
images.
9. No definite evidence of extracapsular extension or seminal invasion by MRI
10. Patient eligible for epidural anesthesia, and general anesthesia (in case of
complication, requiring intervention).
11. Patient is willing and able to give consent and attend all study visits as defined in
the protocol
12. Prostate gland volume should be no greater than 70 cc, volumetrically measured.
Exclusion Criteria:
1. ASA status > 2
2. Contraindications to MRI 2.1. Claustrophobia 2.2. Implanted ferromagnetic materials
or foreign objects 2.3. Known intolerance to the MRI contrast agent (e.g. Gadolinium
or Magnevist) 2.4. Known contraindication to utilization of MRI contrast agent
3. Severely abnormal coagulation (INR>1.5)
4. Patient with unstable cardiac status including:
4.1. Unstable angina pectoris on medication 4.2. Documented myocardial infarction
within 40 days prior to enrolment 4.3. Congestive heart failure NYHA class IV 4.4.
Unstable arrhythmia status, already on anti-arrhythmic drugs
5. Severe hypertension (diastolic BP > 100 on medication)
6. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
7. History of orchiectomy, PCa-specific chemotherapy, cryotherapy, Photodynamic therapy
or radical prostatectomy for treatment of prostate cancer; any prior radiation
therapy to the pelvis for prostate cancer or any other malignancy.
8. Patient under medications that can affect PSA for the last 3 months prior to MRgFUS
treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
9. Individuals who are not able or willing to tolerate the required prolonged stationary
supine position during treatment (approximately 3 hrs.)
10. Any rectal pathology, anomaly or previous treatment, which can change acoustic
properties of rectal wall or prevent safe probe insertion (e.g., fistula, stenosis,
fibrosis).
11. Any spinal pathology which can prevent safe administration of epidural anesthesia
12. Identified calcification of 2 mm or more in largest diameter neighboring the rectal
wall (in a distance of less than 5 mm) and interfering with the acoustic beam path.
13. Lower limb musc
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What will happen
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Device; MRgFUS Treatment; Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy; Treatment; ExAblate 2100 Prostate system
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Primary aim
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Safety and initial Effectiveness
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Secondary Aim
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Safety; 24 months; Yes; Incidence and severity of device/treatment related AE's from treatment and up to 24 months follow-up; Effectiveness; 24 months; No; Evaluating effectiveness of ExAblate MRgFUS to achieve adequate tumor control in low risk organ-confined prostate cancer patients based on periodic PSA follow-up (according to study schedule) and TPBx (Transperineal Biopsy) at two years follow-up. (TPBx will be performed between 6 and 24 months, if clinically indicated); Effectiveness; 24 months; No; Assessing post-ExAblate non-perfused volume (NPV) changes from immediate post- treatment measurement to at 6 and 24 months; QOL; 24 months; No; Patients will complete the EPIC-SF12-AUASI questionnaire periodically during study (from baseline up to 24 months post treatment), according to study schedule, to evaluate patient function and satisfaction after prostate cancer treatment.
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London
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