Study Stopped
No funding
High-Intensity Focused Ultrasound in Treating Participants With Intermediate and High-risk Prostate Cancer
Translation of High-intensity Focused Ultrasound (HIFU) or Treatment of Intermediate and High-Risk Prostate Cancer
3 other identifiers
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 3, 2018
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedAugust 22, 2019
August 1, 2019
2 years
April 20, 2018
August 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mean percentage of viable clinically-significant prostate cancer (Gleason pattern 4 or 5) after high-intensity focused ultrasound (HIFU) treatment
Determined by calculating the mean percent of viable cancer tissue remaining after HIFU using two different measurements: histologic examination of excised prostate specimen and histologic examination of post HIFU needle biopsy. Each of these two measurements will be investigated independently using two types of analyses as follows: percent viable cancer in excised prostate specimen and percent viable cells using post-HIFU needle biopsy. Will calculate the mean percent viable cancer across patients along with a corresponding 95% confidence interval based on all 32 fully evaluable patients.
Up to 3 months
Secondary Outcomes (1)
Mean detection level of immunological factors
Up to 3 months
Study Arms (1)
Treatment (HIFU, radical prostatectomy)
EXPERIMENTALHIFU PHASE: Participants undergo mpMRI and CEUS pre-HIFU treatment and then CEUS post-HIFU treatment. Participants then undergo HIFU treatment over 2-2.5 hours. PROSTATECTOMY PHASE: Within 2-4 weeks post-HIFU treatment, participants undergo mpMRI 1-2 days prior to radical prostatectomy. On the day of surgery, participants undergo CEUS prior to radical prostatectomy.
Interventions
Undergo CEUS
Under go HIFU
Undergo mpMRI
Undergo prostatectomy
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inderbir Gill, MD
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2018
First Posted
May 3, 2018
Study Start
July 1, 2019
Primary Completion
July 1, 2021
Study Completion
July 1, 2022
Last Updated
August 22, 2019
Record last verified: 2019-08