Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study | Recruiting
Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study
Health Conditions
  • Localized Low-Intermediate Risk Prostate Cancer
Recruiting
Recruitment Status
NCT01226576
Primary Trial ID Number
Summary
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 to intermediate 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.
Primary Outcome Measures
  • Safety and initial Effectiveness; 6 months
Secondary Outcome Measures
  • Safety; 24 months; Effectiveness; 24 months; Effectiveness; 24 months; QOL; 24 months
Research Question
  • 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 to intermediate 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
Canada; Israel; Italy; Singapore; United Kingdom
Participant Sex
Male
Participant Age Range
50 Years to 75 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
80
Participant Inclusion Criteria
  • 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-intermediate 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 or 7 (no 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 7 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 musculo-skeletal fixed deformities.
  • 14. Prostate with multiple cystic lesions.
  • 15. Evidence for seminal vesicle/lymph node involvement of cancer.
  • 16. Subjects with distance of the less than 2mm margin between the tumor and the prostate
  • capsule
  • 17. Bladder cancer
  • 18. Patient that had TURP procedure before
  • 19. Urethral stricture/bladder neck contracture
  • 20. Patient with baseline symptoms of incontinence defined as urine leak in any of the
  • following circumstances:
  • 20.1. Before the patient can get to the toilet 20.2. When coughing or sneezing 20.3.
  • While being asleep 20.4. While being physically active/exercising 20.5. After
  • finishing urinating and being dressed 20.6. Leaking for no obvious reason
  • 21. Patient with baseline impotence scoring 17 or below in the IIEF-5 (SHIM)
  • questionnaire
  • 22. Active UTI
  • 23. Prostatitis NIH categories I, II and III
  • 24. Implant near (<1 cm) the prostate
  • 25. Interest in future fertility
  • 26. Current participation in another clinical investigation of a medical device or a drug
  • or has participated in such a study within 30 days prior to study enrollment
Participant Exclusion Criteria
  • 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-intermediate 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 or 7 (no 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 7 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 musculo-skeletal fixed deformities.
  • 14. Prostate with multiple cystic lesions.
  • 15. Evidence for seminal vesicle/lymph node involvement of cancer.
  • 16. Subjects with distance of the less than 2mm margin between the tumor and the prostate
  • capsule
  • 17. Bladder cancer
  • 18. Patient that had TURP procedure before
  • 19. Urethral stricture/bladder neck contracture
  • 20. Patient with baseline symptoms of incontinence defined as urine leak in any of the
  • following circumstances:
  • 20.1. Before the patient can get to the toilet 20.2. When coughing or sneezing 20.3.
  • While being asleep 20.4. While being physically active/exercising 20.5. After
  • finishing urinating and being dressed 20.6. Leaking for no obvious reason
  • 21. Patient with baseline impotence scoring 17 or below in the IIEF-5 (SHIM)
  • questionnaire
  • 22. Active UTI
  • 23. Prostatitis NIH categories I, II and III
  • 24. Implant near (<1 cm) the prostate
  • 25. Interest in future fertility
  • 26. Current participation in another clinical investigation of a medical device or a drug
  • or has participated in such a study within 30 days prior to study enrollment
Interventions
Device; MRgFUS Treatment; Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy; [Treatment]
Design Details
Sorry, this information is not available
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study
Secondary Trial Identifying Number
Sorry, this information is not available
Website
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Study Funded By
InSightec
Funder Type
Sorry, this information is not available
Study Sponsored By
InSightec
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

21 Oct 2010

Last Updated

12 Jun 2015

Date Record Refreshed on UKCTG

31 Jul 2015