UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035440
Receipt No. R000025154
Scientific Title Salvage local ablation therapy for radiation-recurrent prostate cancer
Date of disclosure of the study information 2019/01/07
Last modified on 2019/01/04

* 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 Salvage local ablation therapy for radiation-recurrent prostate cancer
Acronym Salvage ablation therapy for radiorecurrent prostate cancer
Scientific Title Salvage local ablation therapy for radiation-recurrent prostate cancer
Scientific Title:Acronym Salvage ablation therapy for radiorecurrent prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 To investigate oncological and funcitional outcomes of salvage high-intensity focused ultrasound(HIFU) in men with radiation -recurrent prostate cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Serum PSA every 3 months
Key secondary outcomes MRI
prostate biopsy
adverse event
QOL questionnaire

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 High-intensity focused ultrasound therapy
once, 2-3 hours
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

Not applicable
Gender Male
Key inclusion criteria 1)recurrent prostate cancer after radiation treatment
2)Clinical T1-2, N0 at initial treatment
3)Serum PSA value < 10ng/ml
4)Age over 20 years old
Key exclusion criteria 1)Infecious disease at urinary tract and/or prostate
2)Metastatic disease
Target sample size 5

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Osamu Ukimura
Organization Kyoto Prefectural University of Medicine
Division name Department of Urology
Zip code
Address 465, Kajiityo, Kawaramachi-Hirokoji, Kamigyo, Kyoto
TEL 075-251-5595
Email uro@koto.kpu-m.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Atsushi Ochiai
Organization Kyoto prefectural University of Medicine
Division name Department of Urology
Zip code
Address 465, Kajiityo, Kawaramachi-Hirokoji, Kamigyo, Kyoto
TEL 075-251-5595
Homepage URL
Email uro@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prfectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prfectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Aiseikai Yamashina Hospital
Matsushita Memorial Hospital
Name of secondary funder(s)

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
2019 Year 01 Month 07 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 Enrolling by invitation
Date of protocol fixation
2019 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 07 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
2019 Year 01 Month 04 Day
Last modified on
2019 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025154

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.