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

Phase 2
50 Years
75 Years
Open (Enrolling)
Localized Low-Risk Prostate Cancer

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Trial Information

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

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

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).

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

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,

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

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)

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and initial Effectiveness

Outcome Description:

Safety: incidence and severity of device/treatment related AEs from treatment and up to 6 months follow-up 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

Outcome Time Frame:

6 months

Safety Issue:



United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

October 2010

Completion Date:

December 2013

Related Keywords:

  • Localized Low-Risk Prostate Cancer
  • MRgFUS
  • Prostate Cancer
  • Low-Risk Prostate Cancer
  • Localized Prostate Cancer
  • InSightec
  • ExAblate
  • Prostatic Neoplasms