UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054497 |
|---|---|
| Receipt number | R000062255 |
| Scientific Title | Multicenter study to evaluate the efficacy and safety of combination therapy with LHRH antagonist, androgen-receptor signaling inhibitor, and denosumab followed by local radiation therapy in patients with multiple metastatic prostate cancer |
| Date of disclosure of the study information | 2024/05/28 |
| Last modified on | 2025/11/28 13:43:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multi-institutional study to evaluate the efficacy and safety of hormone therapy with radiation therapy for prostate cancer with multiple bone metastases
Acronym
Efficacy of multidisciplinary treatment including radiotherapy for prostate cancer with multiple bone metastases
Scientific Title
Multicenter study to evaluate the efficacy and safety of combination therapy with LHRH antagonist, androgen-receptor signaling inhibitor, and denosumab followed by local radiation therapy in patients with multiple metastatic prostate cancer
Scientific Title:Acronym
Efficacy of multidisciplinary treatment including radiotherapy for prostate cancer with multiple bone metastases
Region
| Japan |
Condition
Condition
Patients with prostate cancer who had multiple bone metastases
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the utility and safety of the combination enzalutamide and ADT as a first-line treatment followed by RT for prostate in patients with mCSPC who had high-volume bone metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy of this combination treatments on oncological outcomes
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Degarelix, Denosumab, Enzarutamide, Radiation
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
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
histologically confirmed PCa with high burden synchronous metastatic disease (4 and more bone metastases), Eastern Cooperative Oncology Group performance status of 0-1, adequate bone marrow function (absolute neutrophil count 1500/m3 and more and platelet count 100000/m3 and more), adequate renal function (creatinine 2.0 mg/dL and less and/or creatinine clearance 40 mL/min and more), and adequate hepatic function (total bilirubin 1.5 mg/dL and less).
Key exclusion criteria
Patients who had previously undergone RT for the prostate or pelvis, or had received chemotherapy or hormonal therapy for PCa, were excluded. The patients who received finasteride or dutasteride before the surgery were also excluded from the present study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Koie |
Organization
Gifu University Graduate School of Medicine
Division name
Urology
Zip code
5011194
Address
1-1 Yanagido, Gifu, Japan
TEL
0582306000
koie.takuya.h2@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Kawase |
Organization
Gifu University Graduate School of Medicine
Division name
Urology
Zip code
5011194
Address
1-1 Yanagido, Gifu, Japan
TEL
0582306000
Homepage URL
kawase.makoto.g5@f.gifu-u.ac.jp
Sponsor or person
Institute
Department of Urology, Gifu University Graduate School of Medicine
Takuya Koie
Institute
Department
Personal name
Funding Source
Organization
Astelas pharmacy
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
Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu, Japan
Tel
0582306000
koie.takuya.h2@f.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/cnr2.70355
Number of participants that the trial has enrolled
35
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 05 | Month | 28 | Day |
Last modified on
| 2025 | 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=R000062255
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/11/27 | documents.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/11/28 | polymets data 元.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/11/28 | polymets data.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/62255
