UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020206
Receipt No. R000023336
Scientific Title High-dose-rate brachytherapy as monotherapy for intermediate- and high-risk prostate cancer: A phase II clinical trial
Date of disclosure of the study information 2015/12/20
Last modified on 2019/09/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title High-dose-rate brachytherapy as monotherapy for intermediate- and high-risk prostate cancer: A phase II clinical trial
Acronym Monotherapeutic HDR-BT for intermediate- and high-risk prostate cancer: Phase II
Scientific Title High-dose-rate brachytherapy as monotherapy for intermediate- and high-risk prostate cancer: A phase II clinical trial
Scientific Title:Acronym Monotherapeutic HDR-BT for intermediate- and high-risk prostate cancer: Phase II
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of high-dose-rate brachytherapy (HDR-BT) as monotherapy for intermediate- and high-risk prostate cancer. Especially, to confirm that the trial regimen of 40 Gy/5 fractions/3 days is equivalent to the historical refimens of 48-54 Gy/8-9 fractions/5 days or 45.5 Gy/7 fractions/4 days.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 5-year actuarial biochemical control rate
Key secondary outcomes 5-year actuarial rate of late adverse events (genitourinary and gastrointestinal Grade 3 or more),
5-year actuarial rate of late adverse events (genitourinary and gastrointestinal Grade 2 or more),
and QOL questionnaire (EPIC + SF-8)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Irradiation using high-dose-rate brachytherapy. In total 40 Gy in five fractions (8 Gy per fraction) will be given, with at least 6-hour intervals, at most twice a day, in consecutive 3 days.
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
80 years-old >
Gender Male
Key inclusion criteria 1) Biopsy-proven adenocarcinoma
2) MRI, CT, bone scintigraphy were done, and no lymph node or distant metastasis was detected
3) T1c-4N0M0
4) Intermediate- or high-risk prostate cancer (any of T2b-4, GS >=7, or PSA >=10)
5) No neoadjuvant hormone therapy or <= 1 year if any
6) No apparent deficiency of hematological tests
7) Candidacy of epidural anesthesia
8) Age >=20, <80
9) Written informed consent obtained
Key exclusion criteria 1) Active other malignancy
2) Uncontrollable diabetes mellitus
3) Unstoppable anticoagulant drugs
4) Severe neurocognitive disease
5) Collagen disease
6) Previous surgery or irradiation to the pelvis
7) Previous TUR-P
8) Severe BPH or lower urinaly tract symptoms
9) Low-risk prosatate cancer
10) High-risk prostate cancer with all 3 factors of T3-4, GS >=, and PSA >=20
11) Neoadjucant hormone therapy >1 year
12) Castration-resistant prostate cancer
13) The physician juddged contraindication
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takero
Middle name
Last name Hirata
Organization Osaka University Graduate School of Medicine
Division name Radiation Oncology
Zip code 5650871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3482
Email hirata@radonc.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Takero
Middle name
Last name Hirata
Organization Osaka University Graduate School of Medicine
Division name Radiation Oncology
Zip code 5650871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3482
Homepage URL
Email hirata@radonc.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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 Osaka University Clinical Research Review Committee
Address 2-15 Yamadaoka, Suita, Osaka
Tel 06-6210-8321
Email onaka@dmi.med.osaka-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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 20 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
2015 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 15 Day
Last modified on
2019 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023336

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.