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

NCT ID: NCT03514927

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-07-01

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.

Conditions

Prostate Cancer Stage I AJCC V6; Prostate Cancer Stage II; Prostate Cancer Stage III

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (HIFU, radical prostatectomy)

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.

Group Type: EXPERIMENTAL

Contrast-Enhanced Ultrasound

Intervention Type: PROCEDURE

Undergo CEUS

High-Intensity Focused Ultrasound

Intervention Type: DEVICE

Under go HIFU

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Multiparametric Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo mpMRI

Radical Prostatectomy

Intervention Type: PROCEDURE

Undergo prostatectomy

Interventions

Contrast-Enhanced Ultrasound

Undergo CEUS

Intervention Type: PROCEDURE

High-Intensity Focused Ultrasound

Under go HIFU

Intervention Type: DEVICE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Multiparametric Magnetic Resonance Imaging

Undergo mpMRI

Intervention Type: PROCEDURE

Radical Prostatectomy

Undergo prostatectomy

Intervention Type: PROCEDURE

Other Intervention Names

CEUS; HIFU; high-intensity focused ultrasound therapy; Multiparametric MRI; Prostatovesiculectomy

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)

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inderbir Gill, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2018-00605

Identifier Type: REGISTRY

Identifier Source: secondary_id

4P-17-9

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4P-17-9

Identifier Type: -

Identifier Source: org_study_id