Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT03998657
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT03998657
Study Brief:
Protocol Section:
NCT03998657