Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Risk Prostate Cancer
Diagnosis: Prostate Cancer
NCT ID: NCT01657942
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-184
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.
Brigham and Women's Hospital, Dana-Farber Cancer Institute
Clare Tempany, MD,
Brigham and Women's Hospital
Brigham and Women's Hospital:
Louise Greenberg, 617-732-5441,
- 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
- 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)
- 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.
- ASA status > 2
- Contraindications to MRI
- 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
- 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