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.
Active, not recruiting
N/A
| Name | Type | Description | Interventions |
|---|---|---|---|
| Exablate Treated Arm | Experimental | Treatment with Exablate Prostate 2100 Type-3 System |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 50 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
| Measure: | Incidence and severity of device/procedure-related complications following treatment |
| Time Frame: | 12 months |
| Safety Issue: | |
| Description: | Safety will be evaluated by incidence and severity of device/procedure-related complications following treatment. Adverse events will be recorded and categorized according to severity and relationship to the biopsy procedure, the Exablate procedure, or to the Exablate device. They will be classified based on body system, severity, and frequency. |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | InSightec |
December 19, 2020
