UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046528 |
|---|---|
| Receipt number | R000053086 |
| Scientific Title | The efficacy of neoadjuvant chemohormonal therapy followed by robot-assisted radical prostatectomy and/or radiation therapy for prostate cancer patients with oligometastasis: A prospective multicenter study |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/11/28 05:44:06 |
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Basic information
Public title
The efficacy and safety of neoadjuvant chemohormonal therapy followed by robot-assisted radical prostatectomy and/or radiation therapy for prostate cancer patients with oligometastasis:
A prospective multicenter study
Acronym
The treatment for prostate cancer patients with oligometastasis: A prospective multicenter study
Scientific Title
The efficacy of neoadjuvant chemohormonal therapy followed by robot-assisted radical prostatectomy and/or radiation therapy for prostate cancer patients with oligometastasis:
A prospective multicenter study
Scientific Title:Acronym
multimodal therapy for prostate cancer patients with oligometastasis
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of neoadjuvant chemohormonal therapy followed by robot-assisted radical prostatectomy and/or radiation therapy for prostate cancer patients with oligometastasis:
A prospective multicenter study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Overall survival, disease-specific survival, efficacy, safety
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
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Robot-assisted radical prostatectomy
Metastasis-Directed radiation therapy
Apalutamide
Tgafur/Uracil
LHRH agonist or antagonist
Denosumab
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
| Not applicable |
Gender
Male
Key inclusion criteria
Male patients with prostate cancer (20 years)
Bone metastasis within 3 part
The patients can intake UFT and apalutamide
Performance status 0 or 1
Key exclusion criteria
Bone metastasis with 4 part and greater
The patients who have multiple lymph node metastases
The patients cannot undergo robot-assisted radical prostatectomy due to comorbidities.
The patients cannot undergo radiation therapy
The patients who received chemotherapy
The patients who have osteonecrosis of the jaw
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Koie |
Organization
Gifu University
Division name
Urology
Zip code
5011194
Address
1-1 Yanagido, Gifu
TEL
0582306000
goodwin@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Koie |
Organization
Gifu University
Division name
Urology
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
0582306000
Homepage URL
goodwin@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University
Address
1-1 Yanagido, Gifu
Tel
058-230-6059
rinri@gifu-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
東海大学医学部（神奈川県），横浜市立大学学（神奈川県），獨協医科大学埼玉医療センター（埼玉県），広島市民病院（広島県），東海中央病院（岐阜県），松波総合病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://rinri.niph.go.jp/PublicPage/publictoppage.aspx
Publication of results
Partially published
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
| 2020 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2022 | Year | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053086
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/11/28 | documents (1).pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/11/28 | oligomets data 元.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/11/28 | oligomets data.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/53086
