UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058591 |
|---|---|
| Receipt number | R000066988 |
| Scientific Title | A Multi-institutional Collaborative Study to Evaluate the Efficacy and Safety of Endocrine Therapy (Degarelix, Denosumab, Apalutamide) and Intensity-Modulated Radiation Therapy for Prostate Cancer with Multiple Bone Metastases |
| Date of disclosure of the study information | 2025/07/24 |
| Last modified on | 2025/07/24 21:12:37 |
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Basic information
Public title
A Multi-institutional Collaborative Study to Evaluate the Efficacy and Safety of Endocrine Therapy (Degarelix, Denosumab, Apalutamide) and Intensity-Modulated Radiation Therapy for Prostate Cancer with Multiple Bone Metastases
Acronym
A Prospective Multi-institutional Collaborative Study Aiming for Radical Cure of Prostate Cancer with Extensive Bone Metastases
Scientific Title
A Multi-institutional Collaborative Study to Evaluate the Efficacy and Safety of Endocrine Therapy (Degarelix, Denosumab, Apalutamide) and Intensity-Modulated Radiation Therapy for Prostate Cancer with Multiple Bone Metastases
Scientific Title:Acronym
Multimodal Therapy for Prostate Cancer with Multiple Bone Metastases
Region
| Japan |
Condition
Condition
Prostate Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
o investigate whether multidisciplinary treatment combining hormone therapy and radiation therapy can improve biochemical recurrence and survival rates in prostate cancer patients with multiple bone metastases. Additionally, to examine treatment-related adverse events, patient backgrounds and oncological characteristics of patients who benefit from this treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-Free Survival (PFS)
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
After registration, the following drugs will be administered:
Degarelix: Initial dose of 240mg administered subcutaneously at two abdominal sites (120mg per site). From the second dose onward, 80mg will be administered as a maintenance dose subcutaneously at one abdominal site every 4 weeks. Alternatively, from the second dose onward, 480mg may be administered as a maintenance dose subcutaneously at two abdominal sites every 12 weeks.
Denosumab: 120mg administered subcutaneously once every 4 weeks. Calcium supplements will be administered to prevent hypocalcemia caused by this drug.
Apalutamide: 240mg administered orally once daily (refer to package insert).
One year after treatment initiation, if no apparent disease progression is observed on imaging and blood tests, intensity-modulated radiation therapy will be administered to the prostate and bone metastatic lesions. The treatment outline is described below:
Intensity-Modulated Radiation Therapy for Prostate:
Depending on prostate size and disease status, 2Gy per fraction for 36-39 fractions will be delivered to the prostate (total 72-78Gy). Treatment is typically administered once daily on weekdays (Monday through Friday), completing treatment over approximately 7-8 weeks.
Radiation Therapy for Bone Metastases:
2.5Gy per fraction for 15 fractions will be delivered to bone metastatic lesions (total 37.5Gy). Treatment is typically administered once daily on weekdays (Monday through Friday), completing treatment over approximately 3 weeks.
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
1. Male prostate cancer patients aged 20 years or older with bone metastases at the time of informed consent
2. Prostate cancer patients with 4 or more bone metastases at the time of registration
3. Patients who can take apalutamide orally
4. Patients who can receive degarelix and denosumab administration
5. Patients with an expected survival of at least 6 months at the time of informed consent
6. Patients with Performance Status (PS) 0 or 1 at the time of informed consent
7. Patients from whom written informed consent for participation in this study can be obtained
Key exclusion criteria
1. Patients with 3 or fewer bone metastases, or patients with visceral metastases other than lung metastases
2. Patients unable to visit the hospital for radiation therapy
3. Patients with osteonecrosis of the jaw at the time of informed consent, or patients with severe dental caries
4. Patients who have received anticancer drug treatment such as docetaxel prior to enrollment in this study
5. Patients who have received radiation therapy (regardless of site) prior to enrollment in this study
6. Patients judged ineligible for participation in this study by the principal investigator or co-investigators at the participating medical institutions of this study
Target sample size
35
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
koie.takuya.h2@f.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
5011194
Address
1-1 Yanagido, Gifu
TEL
0582306000
Homepage URL
koie.takuya.h2@f.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
0582306000
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2033 | 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
| 2025 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066988
