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Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01226576
Recruitment Status : Completed
First Posted : October 22, 2010
Last Update Posted : March 13, 2019
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Localized Low-Intermediate Risk Prostate Cancer Device: MRgFUS Treatment Not Applicable

Detailed Description:

Objective of this feasibility trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of low to intermediate risk, localized (organ confined) prostate cancer tumors.

ExAblate treatment will be implemented as a focal tumor-selective therapy, directed at pre-defined volume(s)/sector(s) in the prostate, (identified as cancerous by mapping biopsy with or without multi-parametric MRI), rather than a whole gland or hemi-ablation treatment.

Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of low risk organ confined prostate cancer. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study.

Effectiveness: determine the tumor control effect of ExAblate's MRgFUS focal treatment of low risk organ-confined prostate cancer (confirmed by TRUS-guided Transperineal Mapping Biopsy results).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study
Actual Study Start Date : October 2010
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Treatment
ExAblate Treatment Arm
Device: MRgFUS Treatment
Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy
Other Name: ExAblate 2100 Prostate system

Primary Outcome Measures :
  1. Safety and initial Effectiveness [ Time Frame: 6 months ]
    1. Safety: incidence and severity of device/treatment related AEs from treatment and up to 6 months follow-up
    2. Evaluating Initial effectiveness of ExAblate MRgFUS to achieve adequate tumor control in low risk organ-confined prostate cancer patients, based on 6-mo Transperineal (TP) mapping biopsy (Bx) findings

Secondary Outcome Measures :
  1. Safety [ Time Frame: 24 months ]
    Incidence and severity of device/treatment related AE's from treatment and up to 24 months follow-up

  2. Effectiveness [ Time Frame: 24 months ]
    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)

  3. Effectiveness [ Time Frame: 24 months ]
    Assessing post-ExAblate non-perfused volume (NPV) changes from immediate post- treatment measurement to at 6 and 24 months

  4. QOL [ Time Frame: 24 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01226576

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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sheba Medical Center
Tel Hashomer, Israel
Sapienza University Hospital
Rome, Italy
National Cancer Center Singapore
Singapore, Singapore, 168753
United Kingdom
St. Mary's Hospital
London, United Kingdom
Sponsors and Collaborators

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: InSightec Identifier: NCT01226576     History of Changes
Other Study ID Numbers: PCa004
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Keywords provided by InSightec:
Prostate Cancer
Low-Intermediate Risk Prostate Cancer
Localized Prostate Cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases