UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023242 |
|---|---|
| Receipt number | 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 14:20:08 |
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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
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
sunashoj@mail.goo.ne.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026783
