Prostate Cancer
Conditions
Brief summary
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.
Interventions
DEVICEExablate Prostate Treatment
The Exablate system is a non-invasive thermal ablation device that is being used to ablate tissue. The system combines a focused ultrasound surgery (FUS) delivery system and MRI scanner.
Sponsors
InSightec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of device/procedure-related complications following treatment | 12 months | 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. |
| Proportions of treated subjects reporting negative Gleason 7 biopsy within the prostate biopsy treatment area. | 6 months | Effectiveness will be evaluated by targeted lesion control based on biopsy results. Proportions of treated subjects reporting negative Gleason 7 biopsy within the treatment area and/or MRI verification of index lesion(s) ablation. PSA results and validated subject-reported questionnaires will be summarized. |
Countries
United States
Outcome results
None listed