NCT03998657Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 1 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 17 Jun 2019
- Start date
- 19 Dec 2019
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- InSightec
- Diseases
- Prostate cancer
- NCT number
- NCT03998657
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 19 Dec 2019 to the primary completion date, 30 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Untreated urethral stricture/bladder neck contracture
- Subject not able or willing to tolerate the required prolonged stationary supine position during treatment
- Contraindications to MRI
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: Male · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham & Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Sperling Prostate Center Coordinator of this site? Confirm its status | Delray Beach | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Stanford University School of Medicine Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.