UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of safety and efficacy in prostate cancer patients treated with focal low-dose-rate brachytherapy
Title of the study (Brief title)	Focal prostate brachytherapy
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 in prostate cancer patients treated with focal low-dose-rate brachytherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Probability of acute adverse events
Key secondary outcomes	Biochemical relapse free survival,overall survival, cancer-specific survival, clinical relapse free survival

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	Medicine
Interventions/Control_1	Focal low-dose-rate brachytherapy
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) Biopsy proven prostate cancer. 2) Biopsy positive core rate <=50%. 3) Tumor size not extended half of prostate volume on MRI. 4) Targeted biopsy proven prostate cancer that was detected on MRI. 5) No regional lymph node metastasis. 6) No distant metastasis. 7) Approved by document.
Key exclusion criteria	1) >= Clinical T3a 2) Gleason score >=9 3) Other prostate therapy has been performed including TURP, HoLEP, hyperthermia, and castration 4) History of prostate radiotherapy 5) Lead principal investigator judged inappropriate to enroll the present study.
Target sample size	20

Research contact person
Name of lead principal investigator	Hideyasu Tsumura
Organization	Kitasato University School of Medicine
Division name	Urology
Address	1-15-1 Kitasato, Minami-ku, Sagamihara
TEL	0427789091
Email	tsumura@med.kitasato-u.ac.jp

Public contact
Name of contact person	Hideyasu Tsumura
Organization	Kitasato University School of Medicine
Division name	Urology
Address	1-15-1 Kitasato, Minami-ku, Sagamihara
TEL	0427789091
Homepage URL
Email	tsumura@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine, Department of Urology
Institute
Department

Funding Source
Organization	Kitasato University School of Medicine, Department of Urology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 04 Day
Anticipated trial start date	2018 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 21 Day
Last modified on	2017 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034826