Focal MR-Guided Focused Ultrasound Treatment of Localized Low and Intermediate Risk Prostate Cancer

Description

The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for low risk, organ-confined prostate cancer, with a 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.

Study Start Date

July 2013

Estimated Completion Date

December 2016

Interventions

  • Device: ExAblate MR Guided Focused Ultrasound

Specialties

  • Urology: Oncology,Prostate,Radiology/Diagnostics
  • Oncology: Radiation Oncology,Renal/Urologic
  • Radiology: Ultrasound

MeSH Terms

  • Prostatic Neoplasms

Study ID

InSightec -- PCa003

Status

Unknown

Trial ID

NCT01657942

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

40

Sponsor

InSightec

Inclusion Criteria

  • Patient age between 55 and 75 years, inclusive.
  • Biopsy proven adenocarcinoma of the prostate (using a TRUS-guided 12+ core mapping template), obtained up to 6 months prior to scheduled treatment.
  • Patient with low-risk, early-stage organ-confined prostate cancer (cT1c and cT2a, N0, M0) 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.
  • Patient with PSA less than or equal to 10 ng/mL
  • PSAD <0.15 ng/mL/gr
  • Gleason score 6 (3+3) or less (no 4 or 5 grades), based on TRUS-guided mapping prostate biopsy, as defined in the protocol.
  • Up to two (2) discrete cancerous lesions may be identified in the prostate based on biopsy mapping with or without supporting MRI findings
  • each tumor is not more than 10 mm in maximal linear dimension each tumor should comply with Gleason 6 = (3 + 3) score requirements.
  • No definite evidence of extracapsular extension or seminal invasion by MRI
  • Patient should be eligible for both spinal/epidural anesthesia (planned procedure), and general anesthesia (in case of complication, requiring intervention).
  • Patient is willing and able to give consent attend all study visits and complete all questionnaires as defined in the protocol
  • Prostate gland volume should be no greater than 60 ml, volumetrically measured.

Exclusion Criteria

  • ASA status > 2
  • Contraindications to MRI
  • Claustrophobia
  • Implanted ferromagnetic materials or foreign objects
  • Known intolerance to the MRI contrast agent
  • Severely abnormal coagulation (INR>1.5)
  • Severe hypertension (diastolic BP > 100 on medication)
  • Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
  • Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment
  • alpha reductase inhibitors)
  • Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs. sonication time)
  • Any spinal pathology which can prevent safe administration of epidural/spinal anesthesia
  • Prostate with multiple cystic lesions.
  • Evidence for lymph node involvement of cancer
  • Bladder cancer
  • Patients that had TURP procedure before
  • Urethral stricture/bladder neck contracture
  • Active UTI
  • Prostatitis NIH categories I, II and III.
  • Compromised renal function
  • Implant near (<1 cm) the prostate

Gender

Male

Ages

55 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (9)

Study Location Distance Name Phone Email
Brigham Womens Hospital - Boston, Massachusetts 2.6 miles Louise Greenberg 617-732-5441 lgreenberg@partners.org
Brigham Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles Brian Kunzel 646-227-2259 kunzelb@mskcc.org
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles None None None
University of Virginia - Charlottesville, Virginia 493.4 miles None None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles None None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Connie Sathre 507-538-0540 sathre@mayo.edu
City of Hope - Duarte, California 2,578.2 miles None None None
Stanford University School of Medicine - Stanford, California 2,694.5 miles None None None

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