Trial Search Results

Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions

This extended clinical investigation is a multicenter, prospective, sing arm study intended to provide continued access of the Exablate(R) 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 accepting patients for this trial.

Lead Sponsor:

InSightec

Stanford Investigator(s):

Intervention(s):

  • Device: Exablate Prostate Treatment

Phase:

N/A

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

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ned U. Realiza
650-498-8496
Recruiting