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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
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.
Time frame: Up to 3 months
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.
Time frame: Up to 3 months
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Undergo mpMRI
Undergo prostatectomy