Clinical trial · Interventional
Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions
A Continued Access Study to Evaluate Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
NCT03998657CI-TRIAL-00089173active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exablate Prostate Treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exablate Treated Arm
- description
- Treatment with Exablate Prostate 2100 Type-3 System
- interventionNames
- Device: Exablate Prostate Treatment
Primary outcomes (2)
- measure
- Incidence and severity of device/procedure-related complications following treatment
- timeFrame
- 12 months
- 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.
- measure
- Proportions of treated subjects reporting negative Gleason 7 biopsy within the prostate biopsy treatment area.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.