UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059380 |
|---|---|
| Receipt number | R000067913 |
| Scientific Title | Evaluation of the immune effects of High-Intensity Focused Ultrasound (HIFU) in Prostate Cancer |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/12 21:29:04 |
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Basic information
Public title
Evaluation of the immune effects of High-Intensity Focused Ultrasound (HIFU) in Prostate Cancer
Acronym
Evaluation of the immune effects of High-Intensity Focused Ultrasound (HIFU) in Prostate Cancer
Scientific Title
Evaluation of the immune effects of High-Intensity Focused Ultrasound (HIFU) in Prostate Cancer
Scientific Title:Acronym
Evaluation of the immune effects of High-Intensity Focused Ultrasound (HIFU) in Prostate Cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare antitumor immune responses induced by HIFU with those induced by other treatment modalities in patients with localized prostate cancer.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Temporal changes in antitumor immune responses before and after each treatment modality
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Patients diagnosed with non-metastatic prostate cancer who, after receiving a thorough explanation of treatment options from their attending physician, have chosen either HIFU or RARP; and patients diagnosed with benign prostatic hyperplasia who, after receiving a thorough explanation of treatment options from their attending physician, have chosen TUR-P.
2. Individuals with a PSA level below 20 ng/mL.
3. Individuals who, after receiving sufficient explanation regarding participation in this study, have provided written informed consent of their own free will.
Key exclusion criteria
1. Individuals receiving hormonal therapy.
2. Individuals from whom informed consent could not be obtained.
3. Other individuals deemed inappropriate for the study by the principal investigator or sub-investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sunao |
| Middle name | |
| Last name | Shoji |
Organization
Tokai University Hospital
Division name
Department of Urology
Zip code
259-1193
Address
143 Shimo-Kasuya, Isehara-shi, Kanagawa, Japan
TEL
0463-93-1121
sunashoj@mail.goo.ne.jp
Public contact
Name of contact person
| 1st name | Kumpei |
| Middle name | |
| Last name | Takahashi |
Organization
Tokai University Hospital
Division name
Department of Urology
Zip code
259-1193
Address
143 Shimo-Kasuya, Isehara-shi, Kanagawa, Japan
TEL
0463-93-1121
Homepage URL
t-kumpee@tokai.ac.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
t-kumpee@tokai.ac.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000067913
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000067913
Number of participants that the trial has enrolled
14
Results
Using flow cytometry, we evaluated longitudinal changes in lymphocyte activation, proliferation, and exhaustion. We found that the activation of cytotoxic T cells was sustained after HIFU treatment.
Results date posted
| 2025 | Year | 10 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Median age 70 years old (range: 48 to 74 years
Median PSA level was 6.35ng/ml (range: 4.4 to 9.24 ng/ml)
Participant flow
A total of 9 patients treated with HIFU and 5 patients treated with RARP were included in the study.
Adverse events
None
Outcome measures
Flow cytometry was used to assess longitudinal changes in lymphocyte activation, proliferation, and exhaustion.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Planned: 20 cases; completed: 14 cases.
Management information
Registered date
| 2025 | Year | 10 | Month | 12 | Day |
Last modified on
| 2025 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067913
