Focal MR-Guided Focused Ultrasound Treatment of Localized Low and Intermediate Risk Prostate Cancer
Conditions
Localized Low and Intermediae Risk Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
MRgFUS, Prostate Cancer, Low and Intermediate Risk Prostate Cancer, Localized Prostate Cancer, InSightec, ExAblate
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ExAblate MR Guided Focused Ultrasound Type: Device
Name: ExAblate MR Guided Focused Ultrasound Type: Device
Overall Status
Recruiting
Summary
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.
Detailed Description
Objective of this feasibility trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of low and 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 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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 55 Years
Gender: Male
Criteria: Inclusion Criteria:

- Patient age between 55 and 80 years, inclusive.

- Biopsy proven adenocarcinoma of the prostate (using a TRUS-guided 12+ core mapping biopsy), obtained up to 6 months prior to scheduled treatment.

- Patient with low or intermediate-risk, early-stage organ-confined prostate cancer (T1a up to T2b, 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 20 ng/mL

- Gleason score 6 or 7 (No 5 grades), based on TRUS-guided mapping prostate biopsy, as defined in the protocol.

- Up to two lesions confined hemilaterally, each in up to 2 contiguous sectors, may be identified in the prostate based on biopsy mapping with or without supporting MRI findings Gleason 7 tumors must be MRI visible); each tumor is not more than 10 mm in maximal linear dimension; each tumor should comply with Gleason 6 = (3 + 3) or 7 (4+3 or 3 +4) 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
Locations
City of Hope
Duarte, California, United States
Status: Recruiting
Contact: Maria Brooks - 626-256-4673 - mbrooks@coh.org
Brigham & Women's Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Louise Greenberg - 617-732-5441 - lgreenberg@partners.org
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Connie Sathre - 507-538-0540 - sathre@mayo.edu
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Brian Kunzel - 646-227-2259 - kunzel@mskcc.org
Start Date
July 2013
Completion Date
December 2016
Sponsors
InSightec
Source
InSightec
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page