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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by InSightec
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT01657942
First received: August 2, 2012
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Localized Low-Risk Prostate Cancer
Device: ExAblate MR Guided Focused Ultrasound
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Risk Prostate Cancer: Feasibility Study

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • Safety and Initial Effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    1. 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.
    2. 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).


Estimated Enrollment: 40
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ExABlate MR Guided Focus Ultrasound
ExAblate MR Guided Focused Ultrasound - Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy.
Device: ExAblate MR Guided Focused Ultrasound
ExAblate MR Guided Focused Ultrasound - Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy.
Other Name: ExAblate 2100 Prostate System
Device: ExAblate MR Guided Focused Ultrasound
ExAblate MR Guided Focused Ultrasound

Detailed Description:

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 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 and 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 mapping biopsy results).

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657942

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Maria Brooks    626-256-4673 ext 64402    mbrooks@coh.org   
Principal Investigator: Jeffrey Wong, M.D.         
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Louise Greenberg    617-732-5441    lgreenberg@partners.org   
Principal Investigator: Clare Tempany, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Connie Sathre    507-538-0540    sathre@mayo.edu   
Principal Investigator: David Woodrum, MD         
Sponsors and Collaborators
InSightec
  More Information

No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01657942     History of Changes
Other Study ID Numbers: PCa003
Study First Received: August 2, 2012
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by InSightec:
MRgFUS
Prostate Cancer
Low-Risk Prostate Cancer
Localized Prostate Cancer
InSightec
ExAblate

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

ClinicalTrials.gov processed this record on August 01, 2014