High-Intensity Focused Ultrasound in Treating Participants With Intermediate and High-risk Prostate Cancer

Withdrawn before enrolling · Not applicable

Conditions studied: Prostate Cancer Stage I AJCC V6, Prostate Cancer Stage II, Prostate Cancer Stage III

In brief

This phase II trial studies how well high-intensity focused ultrasound works in treating participants with intermediate and high-risk prostate cancer. High-intensity focused ultrasound uses high frequency sound waves to deliver a strong beam which may target and destroy a specific part of the prostate, while minimizing damage to surrounding structures and tissue.

Key facts

Study ID: NCT03514927
Run by: University of Southern California
People needed: 0
Starts: 2019-07-01
Expected to finish: 2022-07-01
Last updated by the study team: 2019-08-22

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Male having a diagnosis of clinically-significant prostate cancer (CsPCa) made within the past 12 months (Gleason 7-9) with no evidence of metastatic disease; all outside pathology will be re-reviewed at University of Southern California (USC) to verify diagnosis
Patients have elected to undergo radical prostatectomy (RP) as treatment of choice and have to be a surgical candidate for RP; this determination will be made by the patient in conjunction with their treating urologist and is current standard of practice
Standard preoperative evaluation is performed and deemed satisfactory to proceed to surgery as per their treating urologist
Ability to understand AND willingness to sign a written informed consent
Patients must be willing to undergo HIFU, CEUS, MRI and prostate biopsy pre-RP for research purposes

You may not qualify if…

Patients may not be receiving any other investigational agents or have received any definitive prostate cancer (PCa)-specific treatment (en-bloc resection of bladder tumors [EBRT], Brachytherapy etc) prior
Patients with known metastases would be excluded from this clinical trial
Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinical significant cardiac arrhythmia (rate controlled atrial fibrillation allowed), or psychiatric illness/social situations that would limit compliance with study requirements
Patients with active autoimmune diseases or active immune suppressive therapy or inflammatory bowel disease; a low dose steroid daily administration (equivalent dexamethasone < 10mg/day) is acceptable
Patients with rectal disease
Patients who are unable to undergo MRI
Patients with convincing evidence of extraprostatic extension or T4 disease on digital rectal examination (DRE)

Where it is running

USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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