UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023145 |
|---|---|
| Receipt number | R000026682 |
| Scientific Title | Examination of the effectiveness and safety of multidisciplinary therapy with docetaxel for high-risk prostate cancer |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2023/08/31 10:22:23 |
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Basic information
Public title
Examination of the effectiveness and safety of multidisciplinary therapy with docetaxel for high-risk prostate cancer
Acronym
Multidisciplinary therapy with docetaxel for high-risk prostate cancer
Scientific Title
Examination of the effectiveness and safety of multidisciplinary therapy with docetaxel for high-risk prostate cancer
Scientific Title:Acronym
Multidisciplinary therapy with docetaxel for high-risk prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine th effectiveness and safety of combined modality therapies (hormone therapy, docetaxel chemotherapy, and subsequent surgery or radiation therapy)for high-risk hormone sensitive prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
biochemical recurrence-free survival (PSA)
Key secondary outcomes
overall survival, safety of radiation therapy or surgery after administration of docetaxel
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chemotherapy with docetaxel for hormone-sensitive high-risk prostate cancer.
DOC 70mg/m2 per 3 or 4 weeks, 6 cycles
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. Histologically proven adenocarcinoma of the prostate.
2. Must be male and 20 years or older with criteria for administration of docetaxel.
3. Meet either following conditions by MRI/CT, bone scan, or biopsy at diagnosis; PSA > 50ng/ml, Gleason score > 8-10, locally invasive (T3b or 4), viceral metastases, or high volume cancer with multiple metastases.
4. Give informed consent.
5. ECOG Performance Status of 0 or 1.
Key exclusion criteria
1.Males under the age of 20.
2. Refuses to give informed consent.
3. Refuses or is unable to have pelvic MRI or CT scan.
4. Without criteria for administration of docetaxel.
5. Deemed higher risk of administration of docetaxel by urologists or other physicians.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Horie |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Urology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan 1138421
TEL
03-5802-1227
shorie@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Nagata |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Urology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan 1138421
TEL
03-5802-1227
Homepage URL
m-nagata@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
medical care with docetaxel at patient's own expense
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB secretariat, Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2016 | Year | 09 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2016 | Year | 07 | Month | 13 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026682
