UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023242
Receipt No. R000026783
Scientific Title Focal therapy for localized prostate cancer with high-intensity focused ultrasound
Date of disclosure of the study information 2016/07/20
Last modified on 2020/07/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Focal therapy for localized prostate cancer with high-intensity focused ultrasound
Acronym Focal therapy for localized prostate cancer with HIFU
Scientific Title Focal therapy for localized prostate cancer with high-intensity focused ultrasound
Scientific Title:Acronym Focal therapy for localized prostate cancer with HIFU
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness and safety of focal therapy with HIFU for localized prostate cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Oncological outcomes
2. Urinary continence, erectile dysfunction
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Focal therapy for localized prostate cancer with high-intensity focused ultrasound
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1. The patients with PSA level with and less than 20 ng/ml.
2. The consecutive patients who were diagnosed localization of the significant cancer in the prostate.
Key exclusion criteria The patients who have anal stenosis.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Sunao
Middle name
Last name Shoji
Organization Tokai University Hachioji Hospital
Division name Department of Urology
Zip code 192-0032
Address 1838 Ishikawa-machi, Hachioji, Tokyo, Japan 192-0032
TEL 042-639-1111
Email sunashoj@mail.goo.ne.jp

Public contact
Name of contact person
1st name Sunao
Middle name
Last name Shoji
Organization Tokai University Hachioji Hospital
Division name Department of Urology
Zip code 192-0032
Address 1838 Ishikawa-machi, Hachioji, Tokyo, Japan 192-0032
TEL 042-639-1111
Homepage URL
Email sunashoj@mail.goo.ne.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization Tokai University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokai University School of Medicine
Address 143 Shimokasuya, Isehara, Kanagawa, Japan
Tel 0463-93-1121
Email sunashoj@mail.goo.ne.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東海大学医学部付属八王子病院

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s10147-020-01723-9
Number of participants that the trial has enrolled 90
Results We treated 90 men (median age: 70 years; median PSA level: 7.26 ng/ml). Catheterization was performed within 24 hours after the treatment in all patients. Biochemical disease-free rate was 92.2% during 21 months follow-up when use of Phoenix ASTRO definition. In follow-up biopsy, significant cancer was detected in 8.9% of the patients in un-treated areas. Urinary functions were preserved preoperative levels at 3 or 6 months. Rates of ED and ejaculation who had the functions were 86% and 70%, respectively.
Results date posted
2020 Year 07 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 06 Month 17 Day
Baseline Characteristics Median age 70 years old (range: 39 to 85 years
Median PSA level was 7.26 ng/ml (range: 2.48 to 19.95 ng/ml)
Risk classifications were low: n= 31, intermediate: n=44, and high: n=15
Participant flow Of the 482 patients who were received MRI-TRUS fusion image-guided biopsy and 12-cores transperineal systematic biopsy, 178 patients were satisfied the inclusion criteria. After the informed consent, patients who had the lesion includes urethra and bilateral PZ close to NVB, the severe anal stricture, and difficulty to understand what is the focal therapy, were excluded from the study. The focal therapy was performed for the 90 patients, and these patients were followed up at least 1 year.
Adverse events 4 patient (4.4%) suffered Grade 2 (1 case) and Grade3 (3 cases) urinary tract infection at 1 month after the treatment
3 patients (3.3%) suffered Grade 3 urethral strictures at 3 months after the treatment
No patients suffered incontinence and recto-urethral fistula.
Among the 43 patients who had erectile function without phosphodiesterase-5 inhibitor (PDE-5 inhibitor) before treatment, post-treatment erectile dysfunction rates without PDE-5 inhibitor was 86% (n=37) at 12 months after the treatment.
Among the 43 patients who had erectile function, ejaculation was preserved in 70% (n=30) at 12 months post-treatment.
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
2016 Year 04 Month 01 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 20 Day
Last modified on
2020 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.