UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001537 |
|---|---|
| Receipt number | R000001844 |
| Scientific Title | Phase III randomized trial of combined androgen deprivation with high dose rate brachytherapy in locally advanced prostate cancer |
| Date of disclosure of the study information | 2008/12/01 |
| Last modified on | 2016/04/27 13:55:33 |
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Basic information
Public title
Phase III randomized trial of combined androgen deprivation with high dose rate brachytherapy in locally advanced prostate cancer
Acronym
Phase III randomized trial of combined androgen deprivation with high dose rate brachytherapy in locally advanced prostate cancer
Scientific Title
Phase III randomized trial of combined androgen deprivation with high dose rate brachytherapy in locally advanced prostate cancer
Scientific Title:Acronym
Phase III randomized trial of combined androgen deprivation with high dose rate brachytherapy in locally advanced prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1. To evaluate the biochemical progression-free survival of patients with locally advanced prostate cancer treated by high dose rate brachytherapy and external beam radiotherapy combined with long-term (40 months) hormonal therapy in comparison with short-term (4 months) hormonal therapy.
2. Surrogate end points of this clinical trial are overall survival, cause specific survival and clinical progression-free survival, QOL and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Biochemical progression-free survival (PFS)
Key secondary outcomes
Overall survival
Cause- specific survival
Clinical progression-free survival
QOL
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Patients receive neoadjuvant hormonal therapy for three months and undergo high dose rate brachytherapy and external radiation therapy with concurrent hormonal therapy. Patients then receive adjuvant hormonal therapy for up to 36 months.
Interventions/Control_2
Patients receive neoadjuvant hormonal therapy for three months and undergo high dose rate brachytherapy and external radiation therapy with concurrent hormonal therapy. Patients are followed up without adjuvant hormonal therapy.
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Histologically confirmed adenocarcinoma of the prostate
2. Previously untreated disease
3. Prostate-Specific Antigen (PSA) 20.1-100 ng/mL
4. T2N0M0(Gleason score >or= 8) or T3N0M0(Any Gleason score)
5. Rate of positive core of prostate biopsy >or= 50%
6. ECOG performance status 0-1
7. Age <or= 80
Key exclusion criteria
1. Patients with other cancer requiring treatment
2. Patients with serious complications
3. Patients who fall under the following(Leukocyte count < 3,000/uL, Hemoglobin < 10.0g/dL, Platelet count < 75,000/uL, AST, ALT and ALP > 2.5 times upper limit of normal (ULN), Serum Creatinine > 1.5 times ULN)
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Hara |
Organization
Wakayama Medical University
Division name
Department of Urology
Zip code
Address
811-1, Kimiidera, Wakayama City, Wakayama, 641-8590, Japan
TEL
073-441-0637
hara@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isco Hara, M.D. |
Organization
Wakayama Medical University
Division name
Department of Urology
Zip code
Address
811-1, Kimiidera, Wakayama City, Wakayama, 641-8590, Japan
TEL
073-441-0637
Homepage URL
hara@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University, Department of Urology
Institute
Department
Personal name
Funding Source
Organization
Department of Urology
Wakayama Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2008 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 01 | Day |
Last modified on
| 2016 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001844
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