Prostate Cancer Stage I AJCC V6NCT03514927
High-Intensity Focused Ultrasound in Treating Participants With Intermediate and High-risk Prostate Cancer
A study testing Contrast-Enhanced Ultrasound, High-Intensity Focused Ultrasound and Laboratory Biomarker Analysis in people with Prostate Cancer Stage I AJCC V6 and Prostate Cancer Stage II, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer Stage I AJCC V6, Prostate Cancer Stage II, Prostate Cancer Stage III
- What is being tested?
- Contrast-Enhanced Ultrasound, High-Intensity Focused Ultrasound and Laboratory Biomarker Analysis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Translation of High-intensity Focused Ultrasound (HIFU) or Treatment of Intermediate and High-Risk Prostate Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Contrast-Enhanced Ultrasound, High-Intensity Focused Ultrasound, Laboratory Biomarker Analysis, Multiparametric Magnetic Resonance Imaging, Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-Enhanced UltrasoundProcedure or surgery
Also called CEUS
Undergo CEUS
High-Intensity Focused UltrasoundDevice
Also called HIFU, high-intensity focused ultrasound therapy
Under go HIFU
Laboratory Biomarker AnalysisOther
Correlative studies
Multiparametric Magnetic Resonance ImagingProcedure or surgery
Also called Multiparametric MRI
Undergo mpMRI
Radical ProstatectomyProcedure or surgery
Also called Prostatovesiculectomy
Undergo prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (HIFU, radical prostatectomy) | Experimental | 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. Receives: Procedure: Contrast-Enhanced Ultrasound; Device: High-Intensity Focused Ultrasound; Other: Laboratory Biomarker Analysis; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (1)
Mean detection level of immunological factors
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Stage I AJCC V6Studies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Inderbir Gill, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514927
- Sponsor's protocol ID
- 4P-17-9
- Other IDs
- NCI-2018-00605, 4P-17-9, P30CA014089
- Status last verified
- Aug 2019
- First submitted
- 20 Apr 2018
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of High-intensity Focused Ultrasound (HIFU) or Treatment of Intermediate and High-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT03514927
- Acronym / sponsor ID
- 4P-17-9
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (HIFU, radical prostatectomy) | Experimental | Procedure: Contrast-Enhanced Ultrasound, Device: High-Intensity Focused Ultrasound, Other: Laboratory Biomarker Analysis, Procedure: Multiparametric Magnetic Resonance Imaging, Procedure: Radical ProstatectomyHIFU 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-Enhanced UltrasoundAlso: CEUSUndergo CEUS | Procedure or surgery | Treatment (HIFU, radical prostatectomy) |
| High-Intensity Focused UltrasoundAlso: HIFU, high-intensity focused ultrasound therapyUnder go HIFU | Device | Treatment (HIFU, radical prostatectomy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (HIFU, radical prostatectomy) |
| Multiparametric Magnetic Resonance ImagingAlso: Multiparametric MRIUndergo mpMRI | Procedure or surgery | Treatment (HIFU, radical prostatectomy) |
| Radical ProstatectomyAlso: ProstatovesiculectomyUndergo prostatectomy | Procedure or surgery | Treatment (HIFU, radical prostatectomy) |
Primary outcome
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.
1 secondary outcome
Mean detection level of immunological factors
Time frame: Up to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inderbir Gill, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-Enhanced Ultrasound, High-Intensity Focused Ultrasound and Laboratory Biomarker Analysis in people with Prostate Cancer Stage I AJCC V6 and Prostate Cancer Stage II, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.