Clinical trial NCT03514927: High-Intensity Focused Ultrasound in Treating Participants With Intermediate and High-risk Prostate Cancer
Official title: Translation of High-intensity Focused Ultrasound (HIFU) or Treatment of Intermediate and High-Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer Stage I AJCC V6
Prostate Cancer Stage II
Prostate Cancer Stage III
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-05-03
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: PRIMARY OBJECTIVES:

I. Histologic assessment of cancer kill in the post high-intensity focused ultrasound (HIFU) needle biopsy and excised treated lobe 2-4 weeks after treatment with HIFU.

II. Radiologic assessment of areas suspicious for residual cancer in the treated lobe on multiparametric magnetic resonance imaging (mpMRI) and/or contrast enhanced ultrasound (CEUS) 2-4 weeks post-HIFU (immediately prior to radical prostatectomy).

SECONDARY OBJECTIVES:

I. Assessment of differences in tumor microenvironment, specifically upregulation of the immune system, before and after HIFU treatment on both the treated and untreated lobes.

II. Assessment of HIFU parameters needed to achieve dose-escalation, in the event that such escalation is needed per our study design.

OUTLINE:

HIFU 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.

After completion of study treatment, participants are followed up at 3 months.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Mean percentage of viable clinically-significant prostate cancer (Gleason pattern 4 or 5) after high-intensity focused ultrasound (HIFU) treatment
timeFrame: Up to 3 months
Secondary outcomes:
measure: Mean detection level of immunological factors
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Inderbir Gill, MD
role: PRINCIPAL_INVESTIGATOR
References: