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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001537
Receipt No. 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

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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
Email 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
Email hara@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University, Department of Urology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001844

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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