UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot study for targeted focal cryotherapy of localized prostate cancer
Title of the study (Brief title)	Targeted focal cryotherapy for localized prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To conduct the pilot study of targeted focal therapy for the localized three-dimensionally mapped prostate cancer using minimally invasive image-guided cryoablation of prostate
Basic objectives2	Others
Basic objectives -Others	To demonstrate feasibility to maintain quality of life with preserve the healthy prostate and vital peri-prostate anatomy
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate of adverse event (from operative day to post-op 6-months)
Key secondary outcomes	Control rate of clinically significant cancer (from operative day to post-op 6-months) Patient-reported quality of life (from pre-op to post-op 6-months)

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	Cryosurgery
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) Clinically significant prostate cancer proven by prostate biopsy, imaging, and biomarker 2) The targeted prostate cancer foci having three-dimensional distance of >5mm from the neurovascular bundle and external urinary sphincter 3) No distant metastasis
Key exclusion criteria	1) Drug treatment for prostate cancer within 90 days from consented day 2) Anti-androgen therapy for BPH within 90 days from consented day 3) Difficulty of undergoing transrectal ultrasonography 4) Active cancer in other organ 5) Attending physician determines that the ineligible
Target sample size	5

Research contact person
Name of lead principal investigator	Osamu Ukimura, MD, PhD
Organization	Kyoto Prefectural University of Medicine
Division name	Urology
Address	Kawaramachi-Hirokoji, Kyoto 602-8566
TEL	075-251-5595
Email	ukimura@koto.kpu-m.acjp

Public contact
Name of contact person	Osamu Ukimura, MD, PhD
Organization	Kyoto Prefectural University of Medicine
Division name	Urology
Address	Kawaramachi-Hirokoji, Kyoto 602-8566
TEL	075-251-5595
Homepage URL	https://www.KPUM-Urology.com
Email	uro1@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Urology, Kyoto Prefectural University of Medicine
Institute
Department

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

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	京都府立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 05 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 05 Month 31 Day
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2018 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	All five cases with organ-confined prostate cancer underwent targeted focal cryoablation therapy, resulting in demonstrating of its safety and effectiveness.
Other related information

Management information
Registered date	2016 Year 01 Month 13 Day
Last modified on	2018 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023498