UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008887 |
|---|---|
| Receipt number | R000010426 |
| Scientific Title | Randomized control study to evaluate the efficacy of adjuvant androgen deprivation therapy after rotational IMRT in patients with high risk prostate cancer |
| Date of disclosure of the study information | 2012/09/10 |
| Last modified on | 2021/03/17 09:35:56 |
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Basic information
Public title
Randomized control study to evaluate the efficacy of adjuvant androgen deprivation therapy after rotational IMRT in patients with high risk prostate cancer
Acronym
Randomized control study to evaluate the efficacy of adjuvant androgen deprivation therapy after rotational IMRT in patients with high risk prostate cancer
Scientific Title
Randomized control study to evaluate the efficacy of adjuvant androgen deprivation therapy after rotational IMRT in patients with high risk prostate cancer
Scientific Title:Acronym
Randomized control study to evaluate the efficacy of adjuvant androgen deprivation therapy after rotational IMRT in patients with high risk prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of long-term adjuvant androgen deprivation therapy to 76 Gy external beam radiation therapy with rotational IMRT in patients with high-risk prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
PSA-progression free survival
Key secondary outcomes
Overall survival
Cause-specific survival
QOL
Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Patients receive Combined Androgen Blockade (CAB) with LH-RH agonist and anti-androgen for 4 months as neoadjuvant hormonal therapy. After that, patients receive 76Gy external beam radiotherapy (EBRT) with Rotational IMRT for about 2 months (CAB is continued during radiotherapy period but no further hormonal treatment after EBRT).
Interventions/Control_2
Patients receive Combined Androgen Blockade (CAB) with LH-RH agonist and anti-androgen for 4 months as neo-adjuvant hormonal therapy. After that, patients receive 76Gy external beam radiotherapy (EBRT) with Rotational IMRT for about 2 months (CAB is continued during radiotherapy period and only LH-RH agonist is continued for 24 months as adjuvant hormonal therapy after EBRT).
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male
Key inclusion criteria
1.High risk prostate cancer patient
(by NCCN recurrence risk)
2.Performance status 0-1 (ECOG)
3.Age: 40-79 years old
4.Patients who satisfy the following
(1)WBC>=3.0x103/microL
(2)hemoglobin>=10.0 g/dL
(3) platelet>=10x104/microL
(4)erum creatinine<=2.0 mg/dL
(5)AST<=100 IU/L
(6)ALT<=100 IU/L
5.Written informed consent
Key exclusion criteria
1.Clinical stage T3b or T4
2.Patients who has metastasis with lymph node or distant lesion
3.Patients with active another cancer
4.Patients with uncontrollable hypertension
5.Patients with severe psychiatric disorders
6.Patients with connective tissue disease
7.Patients with poorly controlled diabetes
8.Patients with poorly controlled ischemic heart disease
9.Patients who had prior surgery for prostate (e.g. radical prostatectomy)
10.Patients who had prior radiotherapy (e.g. EBRT, brachytherapy)
11.Patients who had prior orchiectomy
12.Patients who are treated with steroids (except for external use for skin)
13.Patients who are treated with anti-androgen for BPH
14.Patients who considered inappropriate for this trial by physicians
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Taketo |
| Middle name | |
| Last name | Kawai |
Organization
The University of Tokyo Hospital
Division name
Department of Urology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
kawait-uro@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Shiraishi |
| Middle name | |
| Last name | Kenshiro |
Organization
The University of Tokyo Hospital
Division name
Department of Radiology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
kshiraishi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Clinical Research Support Center at The University of Tokyo Hospital
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-3815-5411
crctky-office@umin.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
東京大学医学部附属病院（東京都）
社会福祉法人 仁生会 江戸川病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 10 | 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
| 2011 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 10 | Day |
Last modified on
| 2021 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010426
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