UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy.
Acronym	The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy.
Scientific Title	The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy.
Scientific Title:Acronym	The evaluation of the adverse effects in the prostate cancer patient who received a focal brachytherapy.
Region	Japan

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

Objectives
Narrative objectives1	To examine the urinary symptoms, sexual functions and defecation symptoms of the patients who received the focal brachytherapy prospectively.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	recovery periods from urinary dysfunctions after treatments it is assessed after the treatments by using IPSS, OABSS, IIEF5, FACT-P, NIHCPSI 1 month, 3 months and every 3 months afterwards.
Key secondary outcomes	sexual function assessed by using IIEF5 rectal bleeding

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 Hisashi Middle name Last name Matsushima
Organization	Tokyo Metropolitan Police Hospital
Division name	Department of Urology
Zip code	164-0001
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 Yuji Middle name Last name Hakozaki
Organization	Tokyo Metropolitan Police Hospital
Division name	Department of Urology
Zip code	164-0001
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	Tokyo Metropolitan Police Hospital Clinical Review Comittee
Address	4-22-1 Nakano, Nakano-ku, Tokyo, 164-0001, Japan
Tel	+81-03-5343-5611
Email	yhakozaki11012@gmail.com

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	2017 Year 02 Month 28 Day
Anticipated trial start date	2017 Year 03 Month 09 Day
Last follow-up date	2032 Year 03 Month 31 Day
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	2020 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030389