Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions
This extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) preparation and review period.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: Exablate Prostate Treatment
Eligibility
Inclusion Criteria:
- Biopsy proven adenocarcinoma of the prostate
- Intermediate risk, organ-confined prostate cancer (T1a up to T2b) and voluntarily
chooses Exablate, who may currently be on watchful waiting or active surveillance and
not in need of imminent radical therapy
- Up to 2 MRI visible Gleason 7 confirmed on mapping prostate biopsy that Investigator
deems treatable within a single treatment session; may have secondary Gleason 6 on
ipsilateral or contralateral side confirmed with biopsy and/or MRI
- PSA less than or equal to 20ng/mL
Exclusion Criteria:
- Evidence of distant prostate cancer including lymph node involvement and/or metastasis
of cancer
- Subject undergoing androgen deprivation therapy, initiating any new medication that
can affect PSA, or history of bilateral orchiectomy
- Active bladder cancer, active UTI, or untreated prostatitis
- Untreated urethral stricture/bladder neck contracture
- Prostate-specific chemotherapy, brachytherapy, cryotherapy, photodynamic therapy,
radical prostatectomy, or focal therapy (excluding FUS); or any prior radiation
therapy to the pelvis for prostate cancer or any other malignancy
- Subjects with pathology or implants that may adversely impact treatment due to
acoustics, imaging, or safe probe insertion
- Subject not able or willing to tolerate the required prolonged stationary supine
position during treatment
- Contraindications to MRI
Ages Eligible for Study
50 Years - N/A
Genders Eligible for Study
Male
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ned U. Realiza
650-498-8496
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.
