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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by InSightec
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT01226576
First received: October 21, 2010
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 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.


Condition Intervention Phase
Localized Low-Risk Prostate Cancer
Device: MRgFUS Treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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: 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


Secondary Outcome Measures:
  • Safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Incidence and severity of device/treatment related AE's from treatment and up to 24 months follow-up

  • Effectiveness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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)

  • Effectiveness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessing post-ExAblate non-perfused volume (NPV) changes from immediate post- treatment measurement to at 6 and 24 months

  • QOL [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
ExAblate Treatment Arm
Device: MRgFUS Treatment
Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy
Other Name: ExAblate 2100 Prostate system

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 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).

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 images.
  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, fibrosis).
  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 capsule
  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) questionnaire
  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
  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: NCT01226576

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Paula Spensieri    416-946-4501 ext 4958    paula.spensieri@uhn.on.ca   
Principal Investigator: John Trachtenberg, MD         
Principal Investigator: Sangeet Ghai, MD         
Israel
Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel
Contact: Zohar Dotan, MD    +97235303030    zohar.dotan@sheba.health.gov.il   
Principal Investigator: Zohar Dotan, MD         
Sub-Investigator: Yael Inbar, MD         
Sub-Investigator: Orith Portnoy, MD         
Sub-Investigator: Gil Raviv, MD         
Sub-Investigator: Jacob Ramon, Prof. MD         
Sub-Investigator: Eddie Friedman, MD         
Sub-Investigator: Chaim Birkenshtadt, MD         
Italy
Sapienza University Hospital Not yet recruiting
Rome, Italy
Contact: Carlo Catalano, Prof.    +39 (06) 4455602    carlo.catalano@uniroma1.it   
Principal Investigator: Carlo Catalano, Prof, MD         
Sub-Investigator: Alessandro Napoli, MD         
Sub-Investigator: Giulia Brachetti, MD         
Singapore
National Cancer Center Singapore Recruiting
Singapore, Singapore, 168753
Contact: Juriyah Yatim, RN       juriyah.yatim@sgh.com.sg   
United Kingdom
St. Mary's Hospital Not yet recruiting
London, United Kingdom
Contact: Wladyslaw Gedroyc, Prof. MD    +442033126497    w.gedroyc@imperial.ac.uk   
Principal Investigator: Wladyslaw Gedroyc, Prof. MD         
Sponsors and Collaborators
InSightec
  More Information

No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01226576     History of Changes
Other Study ID Numbers: PCa004
Study First Received: October 21, 2010
Last Updated: April 4, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Israel: Ministry of Health

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 20, 2014