UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038291 |
|---|---|
| Receipt number | R000043646 |
| Scientific Title | A prospective, observational study for outcomes and safety profiles of MRI-guided transurethral ultrasound ablation of the prostate for prostate cancer |
| Date of disclosure of the study information | 2019/10/15 |
| Last modified on | 2024/05/24 10:41:37 |
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Basic information
Public title
A prospective, observational study for outcomes and safety profiles of MRI-guided transurethral ultrasound ablation of the prostate for prostate cancer
Acronym
TULSA observational study
Scientific Title
A prospective, observational study for outcomes and safety profiles of MRI-guided transurethral ultrasound ablation of the prostate for prostate cancer
Scientific Title:Acronym
TULSAPROS study
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Outcome evaluation of MRI-guided transurethral ultrasound ablation of the prostate for localized prostate cancer in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of prostate cancer until 5 years after the treatment
Key secondary outcomes
PSA value, MRI findings, prostate volume, lower urinary tract symptom, sexual function and quality of life evaluation using following questionnaires (IPSS, OABSS, EPIC, SF-12), voiding function using urodynamic studies, required managements for voiding function, adverse events (urinary incontinence, erectile dysfunction, urethral stricture, urinary tract infection, rectal injury, hematuria, voiding dysfunction, urinary retention, others), learning curve of treatment workflow.
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
Localized prostate cancer
T stage: T1, all T2 and T3a
Key exclusion criteria
Patients contraindicated for MRI (patients with intracorporeal metal incompatible with MRI)
Patients without histopathological diagnosis of prostate cancer
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Miura |
Organization
Sapporo Hokuyu Hospital
Division name
Department of Urology and Renal Transplant Surgery
Zip code
003-0006
Address
5-1 Higashisapporo 6-6, Shiroishiku, Sapporo, Japan
TEL
011-865-0111
uromasa@mac.com
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Miura |
Organization
Sapporo Hokuyu Hospital
Division name
Department of Urology and Renal Transplant Surgery
Zip code
003-0006
Address
5-1 Higashisapporo 6-6, Shiroishiku, Sapporo, Japan
TEL
011-865-0111
Homepage URL
uromasa@mac.com
Sponsor or person
Institute
Sapporo Hokuyu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Sapporo Hokuyu Hospital
Address
5-1 Higashisapporo 6-6, Shiroishiku, Sapporo
Tel
011-865-0111
none
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
札幌北楡病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1002/bco2.175
Number of participants that the trial has enrolled
30
Results
1 out of 5 cases whose 1 year data have been analyzed had cancer recurrence outside of the treated area. Urinary continence and QOL data are good.
Results date posted
| 2023 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 06 | Month | 23 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 10 | Month | 15 | Day |
Last modified on
| 2024 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043646
