Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Risk Prostate Cancer
This study is not yet open for participant recruitment.
Verified August 2012 by InSightec
Sponsor:
InSightec
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT01657942
First received: August 2, 2012
Last updated: August 3, 2012
Last verified: August 2012
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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 ]
- 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).
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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
No Contacts or Locations Provided
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: | August 3, 2012 |
| 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 May 16, 2013