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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023145
Receipt No. 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 2020/01/14

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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
Email 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
Email m-nagata@juntendo.ac.jp

Sponsor
Institute Juntendo University Hospital
Institute
Department

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
Email 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 No longer recruiting
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
2022 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
2016 Year 07 Month 13 Day
Last modified on
2020 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026682

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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