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

Status: Recruiting
Phase:
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.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Clare Tempany, MD, Brigham and Women's Hospital

Site-responsible Investigators:

Contacts:
Brigham and Women's Hospital: Louise Greenberg, 617-732-5441, lgreenberg@partners.org

Eligibility 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
  • Email
  • Print
  • Share
  • Text
Highlight Glossary Terms