UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018222 |
|---|---|
| Receipt number | R000019297 |
| Scientific Title | Salvage cryotherapy for the localized recurrence prostate cancer after definitive radiotherapy, a prospective study |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2018/11/24 15:39:45 |
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Basic information
Public title
Salvage cryotherapy for the localized recurrence prostate cancer after definitive radiotherapy, a prospective study
Acronym
Salvage cryotherapy for the localized recurrence prostate cancer after definitive radiotherapy
Scientific Title
Salvage cryotherapy for the localized recurrence prostate cancer after definitive radiotherapy, a prospective study
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shin Egawa |
Organization
Jikei University School of Medicine
Division name
Urology
Zip code
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
s-egpro@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenta Miki |
Organization
Jikei University School of Medicine
Division name
Urology
Zip code
Address
3-25-8 Nishishinbashi, Minato-ku Tokyo 105-8461, JAPAN
TEL
03-3433-1111
Homepage URL
kentamiki@gmail.com
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 07 | 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
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
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019297
