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

• ClinicalTrials.gov Identifier: NCT03514927
• Recruitment Status: Withdrawn
• First Posted: May 3, 2018
• Last Update Posted: August 22, 2019
• Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Southern California

Tracking Information

• First Submitted Date: April 20, 2018
• First Posted Date: May 3, 2018
• Last Update Posted Date: August 22, 2019
• Estimated Study Start Date: July 1, 2019
• Estimated Primary Completion Date: July 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 20, 2018)

Mean percentage of viable clinically-significant prostate cancer (Gleason pattern 4 or 5) after high-intensity focused ultrasound (HIFU) treatment [ Time Frame: Up to 3 months ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 20, 2018)

Mean detection level of immunological factors [ Time Frame: Up to 3 months ]

Determined by immunohistochemistry (IHC) and real-time polymerase chain reaction (RT-PCR). For this will use data collected from IHC on a panel of markers, obtained from both biopsy specimens obtained in the non-treated lobe at the time of biopsy (pre-HIFU) and right before RP (post-HIFU) revisiting them same pre-HIFU biopsy sites. Will compare mean IHC levels of each antibody examined in the pre-HIFU contralateral biopsy to the post-HIFU biopsy obtained from the same site. Mean IHC levels for each antibody will be compared using exact tests and analysis of variance.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• Procedure: Contrast-Enhanced Ultrasound
  Undergo CEUS
  Other Name: CEUS
• Device: High-Intensity Focused Ultrasound
  Under go HIFU
  Other Names:

  • HIFU
  • high-intensity focused ultrasound therapy
• Other: Laboratory Biomarker Analysis
  Correlative studies
• Procedure: Multiparametric Magnetic Resonance Imaging
  Undergo mpMRI
  Other Name: Multiparametric MRI
• Procedure: Radical Prostatectomy
  Undergo prostatectomy
  Other Name: Prostatovesiculectomy

Study Arms

Experimental: 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.

Interventions:

• Procedure: Contrast-Enhanced Ultrasound
• Device: High-Intensity Focused Ultrasound
• Other: Laboratory Biomarker Analysis
• Procedure: Multiparametric Magnetic Resonance Imaging
• Procedure: Radical Prostatectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: August 20, 2019): 0
• Original Estimated Enrollment (submitted: April 20, 2018): 32
• Estimated Study Completion Date: July 1, 2022
• Estimated Primary Completion Date: July 1, 2021 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03514927
• Other Study ID Numbers: 4P-17-9; NCI-2018-00605 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 4P-17-9 ( Other Identifier: USC / Norris Comprehensive Cancer Center ); P30CA014089 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Southern California
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Southern California
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Inderbir Gill, MD; University of Southern California

• PRS Account: University of Southern California
• Verification Date: August 2019