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Localized Low-Intermediate Risk Prostate CancerNCT01226576

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

A study testing MRgFUS Treatment in people with Localized Low-Intermediate Risk Prostate Cancer, run by InSightec at 5 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 years, men only
What is being tested?
MRgFUS Treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
5 sitesin 5 countries
Study dates
Oct 2010to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
  • 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
  • Severe hypertension (diastolic BP > 100 on medication)
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  • 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.
  • Evidence for seminal vesicle/lymph node involvement of cancer.
  • Subjects with distance of the less than 2mm margin between the tumor and the prostate capsule
  • Bladder cancer
  • Patient that had TURP procedure before
  • Urethral stricture/bladder neck contracture
  • 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
  • Patient with baseline impotence scoring 17 or below in the IIEF-5 (SHIM) questionnaire
  • Active UTI
  • Prostatitis NIH categories I, II and III
  • Implant near (<1 cm) the prostate
  • Interest in future fertility
  • 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

Trial locations and contacts

5 sites in 5 countries.

5 sites in 5 countries

Canada1 site

  • University Health Network

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Israel1 site

  • Sheba Medical Center

    Tel HaShomer

Other trials in Israel

Italy1 site

  • Sapienza University Hospital

    Rome

Other trials in Italy

Singapore1 site

  • National Cancer Center Singapore

    Singapore, 168753

Other trials in Singapore

United Kingdom1 site

  • St. Mary's Hospital

    London

Other trials in United Kingdom

About this study

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.

Read the 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).

Being tested
MRgFUS Treatment
Keywords
MRgFUS, Prostate Cancer, Low-Intermediate Risk Prostate Cancer, Localized Prostate Cancer, InSightec, ExAblate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRgFUS TreatmentDevice

    Also called ExAblate 2100 Prostate system

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

Study groups in NCT01226576
Study groupRoleWhat they receive
TreatmentExperimentalExAblate Treatment Arm
Receives: Device: MRgFUS Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (4)

  1. Safety

    Incidence and severity of device/treatment related AE's from treatment and up to 24 months follow-up

    Measured: 24 months

  2. Effectiveness

    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)

    Measured: 24 months

  3. Effectiveness

    Assessing post-ExAblate non-perfused volume (NPV) changes from immediate post- treatment measurement to at 6 and 24 months

    Measured: 24 months

  4. QOL

    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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01226576
Sponsor's protocol ID
PCa004
Status last verified
Mar 2019
First submitted
21 Oct 2010
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23283106

Questions about this trial

What is this clinical trial studying?

A study testing MRgFUS Treatment in people with Localized Low-Intermediate Risk Prostate Cancer, run by InSightec at 5 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada, Israel, Italy, Singapore, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and initial Effectiveness (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01226576, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.

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