UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034795 |
|---|---|
| Receipt number | R000039684 |
| Scientific Title | Impact of local therapy for metastatic prostate cancer |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2018/11/07 10:28:44 |
* 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
Impact of local therapy for metastatic prostate cancer
Acronym
Impact of local therapy for metastatic prostate cancer
Scientific Title
Impact of local therapy for metastatic prostate cancer
Scientific Title:Acronym
Impact of local therapy for metastatic prostate cancer
Region
| Japan |
Condition
Condition
metastatic prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of local therapy for metastatic prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression-free survival
PSA response
Objective response
Base
Study type
Interventional
Study design
Basic design
expanded access
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
| Maneuver |
Interventions/Control_1
Standard therapy + Operation or radiotherapy
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 proven adenocarcinoma of the prostate
Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
Clinical stage M1a (distant lymph node positive), or M1b (bone metastasis)
If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician)
No previous local therapy for prostate cancer
Give informed consent
Prostate deemed resectable by surgeon
Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Hemoglobin (HgB) >= 9 g/dL compatible for surgery
Platelets > 80,000 compatible for surgery
Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery
Key exclusion criteria
Refuses to give informed consent
Deemed to have unresectable disease by surgeon
Received ADT for more than 6 months prior to randomization
Life expectancy of less than 6 months prior to randomization
Known spinal cord compression
M1c disease (solid organ metastasis)
Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to randomization
Previous local therapy for prostate cancer
Previous chemotherapy for prostate cancer
Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier
Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Hatakeyama |
Organization
Hirosaki University School of Medicine
Division name
Urology
Zip code
Address
5 zaifu-chou, Hirosaki, Japan
TEL
0172395091
shingoh@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Hatakeyama |
Organization
Hirosaki University School of Medicine
Division name
Urology
Zip code
Address
5 zaifu-chou, Hirosaki, Japan
TEL
0172395091
Homepage URL
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 07 | Day |
Last modified on
| 2018 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039684
