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

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ClinicalTrials.gov Identifier: NCT03514927
Recruitment Status : Not yet recruiting
First Posted : May 3, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Stage I AJCC V6 Prostate Cancer Stage II Prostate Cancer Stage III Procedure: Contrast-Enhanced Ultrasound Device: High-Intensity Focused Ultrasound Other: Laboratory Biomarker Analysis Procedure: Multiparametric Magnetic Resonance Imaging Procedure: Radical Prostatectomy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Translation of High-intensity Focused Ultrasound (HIFU) or Treatment of Intermediate and High-Risk Prostate Cancer
Estimated Study Start Date : February 25, 2019
Estimated Primary Completion Date : February 25, 2021
Estimated Study Completion Date : February 25, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514927


Contacts
Contact: Ileana Aldana 323-865-0702 Ileana.aldana@med.usc.edu

Locations
United States, California
USC / Norris Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Ileana Aldana    323-865-0702    Ileana.aldana@med.usc.edu   
Principal Investigator: Inderbir Gill         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Inderbir Gill, MD University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03514927     History of Changes
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 )
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases