UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020547 |
|---|---|
| Receipt number | R000023498 |
| Scientific Title | Pilot study for targeted focal cryotherapy of localized prostate cancer |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2018/08/24 14:39:50 |
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Basic information
Public title
Pilot study for targeted focal cryotherapy of localized prostate cancer
Acronym
Targeted focal cryotherapy for localized prostate cancer
Scientific Title
Pilot study for targeted focal cryotherapy of localized prostate cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Osamu Ukimura, MD, PhD |
Organization
Kyoto Prefectural University of Medicine
Division name
Urology
Zip code
Address
Kawaramachi-Hirokoji, Kyoto 602-8566
TEL
075-251-5595
ukimura@koto.kpu-m.acjp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Ukimura, MD, PhD |
Organization
Kyoto Prefectural University of Medicine
Division name
Urology
Zip code
Address
Kawaramachi-Hirokoji, Kyoto 602-8566
TEL
075-251-5595
Homepage URL
https://www.KPUM-Urology.com
uro1@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Urology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
All five cases with organ-confined prostate cancer underwent targeted focal cryoablation therapy, resulting in demonstrating of its safety and effectiveness.
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 05 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023498
