UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Salvage cryotherapy for the localized recurrence prostate cancer after definitive radiotherapy, a prospective study
Title of the study (Brief title)	Salvage cryotherapy for the localized recurrence prostate cancer after definitive radiotherapy
Region	Japan

Condition
Condition	The local recurrence prostatse cancer after definitive radiotherapy
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of salvage cryotherapy for the local recurrence prostate cancer after definitive radiotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Biochemical free survival
Key secondary outcomes	1) Overall survival 2) Clinical progression free survival 3) Safety

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	Cryotherapy
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	50 years-old <=
Age-upper limit	85 years-old >=
Gender	Male
Key inclusion criteria	1) Local recurrence prostate cancer after definitive radiotherapy 2) No distant metastasis 3) The serum PSA level is less than 20 ng/ml before salvage Tx 4) PS 0-1 5) RV volume is less than 50ml 6) No hormone therapy before recurrence.
Key exclusion criteria	1) Double cancer 2) The patient has uncontrol HT, DM and ischemic cardiac disease 3) Using steroid 4) Using hormone therapy within 3month before enrolled.
Target sample size	10

Research contact person
Name of lead principal investigator	Shin Egawa
Organization	Jikei University School of Medicine
Division name	Urology
Address	3-25-8 Nishishinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL	03-3433-1111
Email	s-egpro@jikei.ac.jp

Public contact
Name of contact person	Kenta Miki
Organization	Jikei University School of Medicine
Division name	Urology
Address	3-25-8 Nishishinbashi, Minato-ku Tokyo 105-8461, JAPAN
TEL	03-3433-1111
Homepage URL
Email	kentamiki@gmail.com

Sponsor
Institute	Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Jikei University School of Medicine
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

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2018 Year 11 Month 23 Day
Date of closure to data entry	2018 Year 11 Month 23 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 07 Day
Last modified on	2018 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019297