Medium-term Oncological Efficacy and Patient-reported Outcomes After Focal High-intensity Focused Ultrasound: The
Niklas Westhoff1, Ramona Ernst1, Karl-Friedrich Kowalewski1
1Department of Urology and Urological Surgery, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
Background:
Multiparametric magnetic resonance imaging (mpMRI)/transrectal ultrasound (TRUS) fusion-guided high-intensity focused ultrasound (HIFU) is a focal treatment option for MRI-visible localized prostate cancer (PCa). High-quality evidence regarding the clinical efficacy remains limited.
Objective:
To assess medium-term oncological efficacy along with patient-reported outcome measures (PROMs).
Design, Setting, And Participants:
This prospective single-center cohort study was performed from 2014 to 2020. Patients with primary International Society of Urological Pathologists (ISUP) grade group (GG) ≤2 by combined MRI/TRUS fusion and systematic prostate biopsy and prostate-specific antigen (PSA) <10 ng/ml were included.
Intervention:
MRI/TRUS fusion-guided focal HIFU therapy.
Outcome Measurements And Statistical Analysis:
The primary outcome was the cancer-free rate of the HIFU-treated lesion by biopsy after 1 yr. Secondary endpoints included salvage treatment-free survival (STFS), metastasis-free survival (MFS), overall survival (OS), and PROMs according to International Consortium for Health Outcomes Measurement recommendations.
Results And Limitations:
Fifty patients were included (median [range] age 68 [48-80] yr; median PSA 6.5 [1.2-9.9] ng/ml; GG 1 54% [n = 27], and GG 2 46% [n = 23]). The median (range) PSA decrease from baseline to 12 mo was 51% (35.9-72.7%). In total, 37/50 patients (74%) underwent a 1-yr biopsy. PCa was detected in 23 patients (46%; GG 1 20% [n = 10]; GG >1 26% [n = 13]; infield 40% [n = 20]). At a median follow-up of 42 (13-73) mo, PCa was detected in 30 men (60%). Among all patients, 19 (38%) underwent salvage treatments (median [95% confidence interval] STFS 53 [44.3-61.7] mo). MFS and OS were 100% and 98%, respectively. The Expanded Prostate Cancer Index Composite-26 sexual domain decreased by 20.8 points (p = 0.372).
Conclusions:
MRI/TRUS-guided focal HIFU therapy results in complete cancer ablation in only half of the treated patients after 1 yr, with further recurrences at medium-term follow-up. A decline of potency occurs in a subset of patients.
Patient Summary:
Focal image-guided high-intensity focused ultrasound therapy controls cancer in one of two patients. Its impact on urinary continence and erectile function is low.
Insights
High-intensity focused ultrasound (HIFU) therapy for prostate cancer shows limited efficacy, with only half of patients achieving cancer ablation after one year. Recurrences are noted at medium-term follow-up, impacting potency in some individuals.
Area of Science:
- Urology
- Oncology
- Medical Imaging
Background:
- Multiparametric magnetic resonance imaging (mpMRI)/transrectal ultrasound (TRUS) fusion-guided high-intensity focused ultrasound (HIFU) is a focal treatment for localized prostate cancer (PCa).
- High-quality evidence on its clinical efficacy is limited.
Purpose of the Study:
- To assess the medium-term oncological efficacy of MRI/TRUS fusion-guided focal HIFU therapy.
- To evaluate patient-reported outcome measures (PROMs) following treatment.
Main Methods:
- Prospective single-center cohort study (2014-2020).
- Inclusion criteria: primary ISUP grade group (GG) ≤2, PSA <10 ng/ml.
- Primary outcome: 1-year cancer-free rate by biopsy; secondary outcomes: STFS, MFS, OS, and PROMs.
Main Results:
- Fifty patients (median age 68, median PSA 6.5 ng/ml; 54% GG1, 46% GG2) were included.
- Median PSA decrease of 51% at 12 months.
- At 1-year biopsy, PCa detected in 46% (23/50); at median 42-month follow-up, PCa detected in 60% (30/50).
- 19% underwent salvage treatment; MFS 100%, OS 98%.
- Sexual domain of PROMs decreased by 20.8 points (p=0.372).
Conclusions:
- MRI/TRUS-guided focal HIFU therapy achieves complete cancer ablation in approximately half of treated patients after one year.
- Further cancer recurrences are observed at medium-term follow-up.
- A subset of patients experiences a decline in erectile function.
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