Prostate Cancer Stage II Clinical Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03522155 -
Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies
|
N/A |