NCT01226576

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

8.2 years

First QC Date

October 21, 2010

Last Update Submit

March 11, 2019

Conditions

Localized Low-Intermediate Risk Prostate Cancer

Keywords

MRgFUSProstate CancerLow-Intermediate Risk Prostate CancerLocalized Prostate CancerInSightecExAblate

Outcome Measures

Primary Outcomes (1)

  • Safety and initial Effectiveness

    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

    6 months

Secondary Outcomes (4)

  • Safety

    24 months

  • Effectiveness

    24 months

  • Effectiveness

    24 months

  • QOL

    24 months

Study Arms (1)

Treatment

EXPERIMENTAL

ExAblate Treatment Arm

Device: MRgFUS Treatment

Interventions

MRgFUS TreatmentDEVICE

Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy

Also known as: ExAblate 2100 Prostate system
Treatment

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient of age between 50 to 75 years, inclusive.
  • Biopsy confirmed adenocarcinoma of the prostate, performed up to 6 months prior to scheduled treatment.
  • 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.
  • Patient with PSA less than or equal to 10 ng/mL
  • Gleason score 6 or 7 (no 5 grades), based on TRUS guided Transperineal Mapping Biopsy, as defined in the protocol.
  • 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.
  • 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)
  • 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.
  • No definite evidence of extracapsular extension or seminal invasion by MRI
  • Patient eligible for epidural anesthesia, and general anesthesia (in case of complication, requiring intervention).
  • Patient is willing and able to give consent and attend all study visits as defined in the protocol
  • Prostate gland volume should be no greater than 70 cc, volumetrically measured.

You may not qualify if:

  • ASA status \> 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
  • Severely abnormal coagulation (INR\>1.5)
  • Patient with unstable cardiac status including:
  • 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
  • Severe hypertension (diastolic BP \> 100 on medication)
  • Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
  • 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.
  • 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.)
  • 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).
  • Any spinal pathology which can prevent safe administration of epidural anesthesia
  • 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.
  • Lower limb musculo-skeletal fixed deformities.
  • Prostate with multiple cystic lesions.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Sapienza University Hospital

Rome, Italy

Location

National Cancer Center Singapore

Singapore, 168753, Singapore

Location

St. Mary's Hospital

London, United Kingdom

Location

Related Publications (1)

  • Lindner U, Ghai S, Spensieri P, Hlasny E, Van Der Kwast TH, McCluskey SA, Haider MA, Kucharczyk W, Trachtenberg J. Focal magnetic resonance guided focused ultrasound for prostate cancer: Initial North American experience. Can Urol Assoc J. 2012 Dec;6(6):E283-6. doi: 10.5489/cuaj.12218.

    PMID: 23283106DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2010

First Posted

October 22, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

IT(1)SG(1)IL(1)CA(1)GB(1)