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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026449
Receipt No. R000030340
Scientific Title The evaluation of the relapse-free survival rate in the prostate cancer patient who received a focal brachytherapy.
Date of disclosure of the study information 2017/03/08
Last modified on 2019/03/09

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Basic information
Public title The evaluation of the relapse-free survival rate in the prostate cancer patient who received a focal brachytherapy.
Acronym The evaluation of the relapse-free survival rate in the prostate cancer patient who received a focal brachytherapy.
Scientific Title The evaluation of the relapse-free survival rate in the prostate cancer patient who received a focal brachytherapy.
Scientific Title:Acronym The evaluation of the relapse-free survival rate in the prostate cancer patient who received a focal brachytherapy.
Region
Japan

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

Objectives
Narrative objectives1 To examine the relapse-free survival rate of the patients who received the focal brachytherapy prospectively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes biochemical relapse-free survival rates by using the Phoenix definition
Clinical relapse-free survival rates by using the imaging evaluation by the magnetic resonance imaging after 1 and 4 years of the treatment and the repeat biopsy after 3 year
Key secondary outcomes disease-specific survival rates

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
Maneuver
Interventions/Control_1 To perform the focal brachytherapy for the patients that were diagnosed with prostate cancers by using the MRI/US fusion guided targeted biopsies. The radiation area is between the half and one eighth of the prostate. The radiation area will be decided according to the location of the prostate cancer. All patients start or continue an intake of the alpha blockers after the focal brachytherapy. It is permitted to add an intake of drugs such as anticholinergic drugs and beta adrenergic agonists for the benign prostatic hyperplasia and the overactive bladder syndromes. Serum PSA will be checked every 3 months until 2 years after treatments and every 6 months afterwards. The emergence of the cancer suspected lesions will be examined by MRI. All patients receive repeat biopsies after 3 years of treatments and when the recurrence of prostate cancers were suspected by a PSA check or the MRI imaging.
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 Patients must be under these conditions
1) Patients expect to live more than 10 years after the treatment
2) Prostate cancers are diagnosed by biopsies which they receive in our hospital
3) Patients can receive MRI imaging check and the clinical staging before biopsies is T2aN0.
4) PSA was 20.00 ng/ml or less.
5) The computed tomography (CT) of the chest/abdomen/pelvis and bone scintigraphy do not detect metastatic lesions
6) Functions of the main organs are maintained
6-1) Lliver function; AST and ALT is under 3 times the upper limit of the normal range.
6-2) Heart function;there is no severe abnormality in the electrocardiogram or normal it is confirmed that there is no severe abnormalities by the cardiac ultrasound.
6-3) Renal function; estimated GFR is 15 per minute or more.
7) There is no pubic arch interference in the prostate brachytherapy.
8) It is confirmed at least once that a residual volume is 200 ml or less by an ultrasound.
9) The prostate volume is 50 ml or less by the trans rectal ultrasound.
10) We obtain a written Informed consent of the participation of the study.
11) The result of the prostate biopsy was under these conditions
11-1) The biopsy was performed along the parasagittal, peripheral and base areas of the prostate with an interval of 5 mm. The core number of systematic biopsy is 16 or more and MRI/US fusion-guided biopsy was performed. If the volume of the prostate is small ,the base area of the biopsy can be abbreviated.
11-2) The lesions of the cancer detected core are limited in the targeted area by MRI/US fusion biopsy and the surrounding area.
11-3) The lesions of the cancer detected core was limited in the left or right lobe of the prostate.
12) The result of the biopsy meet any of these Gleason scores and the proportion of the cores.
12-1) Gleason score is 3+3
12-2) Gleason score is 3+4
12-3) Gleason score is 4+3 and the proportion of the core is 50 or less.
Key exclusion criteria Patients must not be under these conditions
1) Patients who had past surgical histories of benign prostatic hyperplasia.
2) Patients who had severe mental disorders.
3) Patients who had other active cancers
4) Patients who doctors judge as unsuitable for this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Matsushima
Organization Tokyo Metropolitan Police Hospital
Division name Department of Urology
Zip code
Address 4-22-1 Nakano, Nakano-ku, Tokyo, 164-0001, Japan
TEL +81-03-5343-5611
Email hmatsu53@me.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Hakozaki
Organization Tokyo Metropolitan Police Hospital
Division name Department of Urology
Zip code
Address 4-22-1 Nakano, Nakano-ku, Tokyo, 164-0001, Japan
TEL +81-03-5343-5611
Homepage URL
Email yhakozaki11012@gmail.com

Sponsor
Institute Tokyo Metropolitan Police Hospital
Institute
Department

Funding Source
Organization Tokyo Metropolitan Police Hospital
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2017 Year 03 Month 08 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
2017 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 09 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
2017 Year 03 Month 07 Day
Last modified on
2019 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030340

Research Plan
Registered date File name
2018/09/10 170227箱_様式-1,2 臨床研究審査申請書FocalTherapy (1).doc

Research case data specifications
Registered date File name
2018/09/10 focaltherapy.xlsx

Research case data
Registered date File name


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