MP18-14: A multi-institutional prospective study of focal therapy with histotripsy using high-intensity focused ultrasound for patients with localized prostate cancer in Japan
Friday, May 3, 2024 3:30 PM to 5:30 PM · 2 hr. (US/Central)
302B
Abstract
Information
Full Abstract and Figures
Author Block
SUNAO SHOJI*, JUN NARUSE, DAICHI NISHIKAWA, MOEKO TAZAWA, TATSUO KANO, Isehara, Japan, SATOSHI KURODA, Hachioji, Japan, TATSUYA UMEMOTO, NOBUYUKI NAKAJIMA, MASAHIRO NITTA, MASANORI HASEGAWA, Isehara, Japan, YOSHIAKI KAWAMURA, Shibuya, Japan, AKIRA MIYAJIMA, Isehara, Japan
Introduction
To evaluate the targeting accuracy and clinical outcomes of focal therapy with histotripsy, using high-intensity focused ultrasound (HIFU), for patients with localized prostate cancer (PC).
Methods
We prospectively enrolled patients with localized PC exhibiting prostate specific antigen (PSA) levels =20 ng/mL. Clinically significant PC (csPC) was detected using magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided target biopsy and systematic biopsy. Focal histotripsy with HIFU was administered to MRI-visible PC lesions. Intra-operatively, energy output was adjusted until hyper-echoic changes became visible across the entire therapeutic area on TRUS, surpassing conventional energy levels and indicating histotripsy. This was a multi-institution study.
Results
We enrolled 240 patients with a median age of 69 years old and a median PSA level of 6.42 ng/mL. Patients were classified by D’Amico risk as follows: low (n=51), intermediate (n=107), and high (n=82). In all patients, blood flow disappeared from the treated area, while blood flow remained just outside the treated area on dynamic contrast-enhanced MRI. The 7- and 5-year biochemical disease-free survivals (Phoenix ASTRO definition) after a single treatment for the low-, intermediate-, and high-risk groups were 89.6%, 88.5%, and 81.6%, and 93.7%, 88.5%, and 84.8%, respectively. CsPC detection rates during follow-up were 7.8%, 8.4%, and 13.4%, in the low-, intermediate-, and high-risk groups, respectively. CsPC was detected outside the treated area in these cases. The Expanded Prostate Cancer Index Composite (EPIC) scores over 24 months revealed that urinary function, urinary bother, urinary irritative/obstructive, and sexual function 1 month after treatment had deteriorated significantly but returned to preoperative levels at 3 or 6 months after treatment. Urinary incontinence, bowel function, bowel bother, sexual bother, hormonal function, and hormonal bother remained unchanged. In terms of complications (CTCAE v.5.0), the rates of urethral strictures (Grade 2), urinary incontinence (Grade 1), and recto-urethral fistula were 2.9%, 1.3%, and 0%, respectively. The rate of erectile dysfunction among patients with functional erections was 24% at 12 months after treatment.
Conclusions
Focal therapy with histotripsy using HIFU demonstrates accuracy as a pre-procedural plan and holds the potential to improve medium-term oncological outcomes without the risk of functional deterioration.
Source Of Funding
none.
Author Block
SUNAO SHOJI*, JUN NARUSE, DAICHI NISHIKAWA, MOEKO TAZAWA, TATSUO KANO, Isehara, Japan, SATOSHI KURODA, Hachioji, Japan, TATSUYA UMEMOTO, NOBUYUKI NAKAJIMA, MASAHIRO NITTA, MASANORI HASEGAWA, Isehara, Japan, YOSHIAKI KAWAMURA, Shibuya, Japan, AKIRA MIYAJIMA, Isehara, Japan
Introduction
To evaluate the targeting accuracy and clinical outcomes of focal therapy with histotripsy, using high-intensity focused ultrasound (HIFU), for patients with localized prostate cancer (PC).
Methods
We prospectively enrolled patients with localized PC exhibiting prostate specific antigen (PSA) levels =20 ng/mL. Clinically significant PC (csPC) was detected using magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided target biopsy and systematic biopsy. Focal histotripsy with HIFU was administered to MRI-visible PC lesions. Intra-operatively, energy output was adjusted until hyper-echoic changes became visible across the entire therapeutic area on TRUS, surpassing conventional energy levels and indicating histotripsy. This was a multi-institution study.
Results
We enrolled 240 patients with a median age of 69 years old and a median PSA level of 6.42 ng/mL. Patients were classified by D’Amico risk as follows: low (n=51), intermediate (n=107), and high (n=82). In all patients, blood flow disappeared from the treated area, while blood flow remained just outside the treated area on dynamic contrast-enhanced MRI. The 7- and 5-year biochemical disease-free survivals (Phoenix ASTRO definition) after a single treatment for the low-, intermediate-, and high-risk groups were 89.6%, 88.5%, and 81.6%, and 93.7%, 88.5%, and 84.8%, respectively. CsPC detection rates during follow-up were 7.8%, 8.4%, and 13.4%, in the low-, intermediate-, and high-risk groups, respectively. CsPC was detected outside the treated area in these cases. The Expanded Prostate Cancer Index Composite (EPIC) scores over 24 months revealed that urinary function, urinary bother, urinary irritative/obstructive, and sexual function 1 month after treatment had deteriorated significantly but returned to preoperative levels at 3 or 6 months after treatment. Urinary incontinence, bowel function, bowel bother, sexual bother, hormonal function, and hormonal bother remained unchanged. In terms of complications (CTCAE v.5.0), the rates of urethral strictures (Grade 2), urinary incontinence (Grade 1), and recto-urethral fistula were 2.9%, 1.3%, and 0%, respectively. The rate of erectile dysfunction among patients with functional erections was 24% at 12 months after treatment.
Conclusions
Focal therapy with histotripsy using HIFU demonstrates accuracy as a pre-procedural plan and holds the potential to improve medium-term oncological outcomes without the risk of functional deterioration.
Source Of Funding
none.
Sessions
MP18: Imaging/Uroradiology I
302B