UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044790 |
|---|---|
| Receipt number | R000050022 |
| Scientific Title | Focal Brachytherapy for localized prostate cancer diagnosed by saturation biopsy |
| Date of disclosure of the study information | 2021/07/09 |
| Last modified on | 2025/01/30 14:46:02 |
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Basic information
Public title
Focal Brachytherapy for localized prostate cancer diagnosed by saturation biopsy
Acronym
Focal Brachytherapy for localized prostate cancer diagnosed by saturation biopsy
Scientific Title
Focal Brachytherapy for localized prostate cancer diagnosed by saturation biopsy
Scientific Title:Acronym
FBTPOC study
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and efficacy of focal brachytherapy for localized prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change at 3 months after focal brachytherapy (FBT) from baseline in the mean 24 h urinary frequency
Key secondary outcomes
1, PSA value before FBT, and at 1,3,6,12,18,24,30,and 36 months after FBT.
2, biochemical failure free survival by Stuttgart definition (PSA nadir + 1.2ng/ml)
3, biochemical failure free survival by Phenix definition (PSA nadir + 2.0ng/ml)
4,pathological findings by saturation biopsy 36 months after FBT
5,findings on MRI 36months after FBT
6,radical treatment free suvival
7,the change at 1,3,6,12,18,24,30,and 36 months after FBT from baseline in IPSS, OABSS, QOL, SHIM, SF-8, and EPIC
8, the change at 1,3,6,and 12 months after FBT from baseline in mean volume voided per micturition, the change at 1,6,and 12 months after FBT from baseline in the mean 24 h urinary frequency
9, the change at 1,3,6,12,18,24,30, and 36months after FBT from baseline in post-voiding residual volume
10, Genitourinary and gastrointestional toxicity (CTCAE version 5.0)
11, comparison of chronological change of PSA between patients with positive findings on saturation biopsy at 36 months after FBT and those with negative findings
12,comparison with historical data (patients who underwent low-dose-rate brachytherapy between May 2010 and April 2020) in the change of IPSS, OABSS, QOL, SHIM, SF-8, EPIC, the mean 24h urinary frequency, mean volume voided per micturition, and toxicity.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
focal brachytherapy
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
1, patients with prostate cancer who undergo low-dose-brachytherapy
2, Gleason score 3+3 or 3+4, the number of positive core on hemi lobe by prostate biopsy (8-12 cores)
3, PSA < 10ng/mL
4, cT1 or cT2a on MRI
5, no metastatic findings on bone scintigraphy, MRI, and CT
6, >20, <85 years old
Key exclusion criteria
1, Patients who underwent TUR-P
2, Patients with pubic arch interference
3, history of androgen deprivation therapy
4, severe mental disorders
5, systemic and continuous use of steroidal drugs
6, history of radiation therapy on pelvis
7, inflammatory bowel disease
8, severe diabetes
9,patients who have difficulty to hold operative position
10, abnormal findings on blood examination
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Nakai |
| Middle name | |
| Last name | Yasushi |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8521
Address
840 Shijyocho, Kashihara, Nara, Japan
TEL
0744223051
nakaiyasusiuro@live.jp
Public contact
Name of contact person
| 1st name | Nakai |
| Middle name | |
| Last name | Yasushi |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8521
Address
840 Shijyocho, Kashihara, Nara, Japan
TEL
0744223051
Homepage URL
nakaiyasusiuro@live.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nihon Medi-Physics Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara
Address
840 Shijyocho, Kashihara, Nara, Japan
Tel
0744223051
ino_rinri@naramed-u.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
| 2021 | Year | 07 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
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
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050022
