UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021079 |
|---|---|
| Receipt number | R000024314 |
| Scientific Title | Upfront abiraterone and docetaxel administration in patients with high-risk metastatic hormone-naive prostate cancer |
| Date of disclosure of the study information | 2016/02/22 |
| Last modified on | 2024/02/26 15:24:43 |
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Basic information
Public title
Upfront abiraterone and docetaxel administration in patients with high-risk metastatic hormone-naive prostate cancer
Acronym
UFAD in mHNPC
Scientific Title
Upfront abiraterone and docetaxel administration in patients with high-risk metastatic hormone-naive prostate cancer
Scientific Title:Acronym
UFAD in mHNPC
Region
| Japan |
Condition
Condition
Metastatic prostate cancer without initial treatment
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical impact of upfront abiraterone acetate or docetaxel administration on clinical progression and survival in patients with high-risk metastatic prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Disease specific survival, overall survival, safety, QOL, pain score, symptomatic skeletal event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
High-risk group (two of the following risk factors: Gleason score of more than equal 8, number of bone metastasis of more than equal 3,pretreatment visceral metastasis): patients receive androgen-deprivation therapy (including leuteinizing hormone-releasing hormone [LHRH] agonist, LHRH antagonist, surgical castration with and without bicalutamide). Patients also receive 1) docetaxel (6 times of 70 mg/m2/months), 2)abiraterone acetate 1000mg/day, or 3)no additional treatment. Patients select one of the treatment options by themselves.
Interventions/Control_2
Low-risk group (not high-risk): patients receive androgen-deprivation therapy (as in high-risk group).
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
Patients who meet the criteria as described below will be included:
1.Historically confirmed prostate cancer
2.Metastatic disease on radiographic examinations without any initial treatment
3.20 years and older
4.ECOG performance status 0-2
5.Plan to receive androgen-deprivation therapy including leuteinizing hormone-releasing hormone (LHRH) agonist, LHRH antagonist, surgical castration with and without bicalutamide
6.Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following
criteria
*Leukocyte counts >= 3,000/mm3
*Platelets >= 750,000/mm3
*Hemoglobin concentration >= 9.0 g/dL
*AST <= 90IU
*ALT <= 100IU
*Total bilirubin <=2.0mg/dL.
*Serum creatinine, <= 3.0mg/dL
7.Agree with the protocol with signed informed consent
Key exclusion criteria
Patients who meet the criteria below will be excluded:
1.Severe cardiovascular disease and diabetes mellitus
2.Chronic pulmonary disease
3.Allergy to taxanes
4. Active concomitant malignancy
5. Difficulty of understanding of the trial because of mental disease
6.Inappropriate patients for this study judged by the physicians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Narita |
Organization
Akita University Graduate School of Medicine
Division name
Urology
Zip code
010-8543
Address
1-1-1 Hondo, Akita, Akita, Japan
TEL
81-18-884-6156
nari6202@gipc.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Narita |
Organization
Akita Univerisity Guraduate School of Medicine
Division name
Urology
Zip code
010-8543
Address
1-1-1 Hondo, Akita, Akita, Japan
TEL
81-18-884-6156
Homepage URL
nari6202@gipc.akita-u.ac.jp
Sponsor or person
Institute
Department of Urology, Akita University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Clinical Research Review Board, Akita University
Address
Hasumuma, Hiroomote 44-2, Akita, Akita, Japan
Tel
018-884-6461
nintei@hos.akita-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
| 2016 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10147-022-02203-y
Publication of results
Partially published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10147-022-02203-y
Number of participants that the trial has enrolled
301
Results
Upfront ABI provided better CRPC-free survival than upfront DOC; however, no significant differences in PFS2 or OS were observed between the two groups. Personalized management based on prognostic risk factors may benefit patients with mCSPC treated with upfront intensified therapies.
Results date posted
| 2024 | Year | 02 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 01 | Month | 24 | Day |
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 | 02 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 01 | 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 | 02 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024314
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