UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032554 |
|---|---|
| Receipt number | R000036994 |
| Scientific Title | Prostate Cancer Lesion Targeted Cryoablation: Investigator Initiated Trial |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2023/05/31 12:18:46 |
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Basic information
Public title
Prostate Cancer Lesion Targeted Cryoablation: Investigator Initiated Trial
Acronym
Procry
Scientific Title
Prostate Cancer Lesion Targeted Cryoablation: Investigator Initiated Trial
Scientific Title:Acronym
Procry
Region
| Japan |
Condition
Condition
Localized prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the effecacy and safety of targeted focal cryotherapy using Visual ICE for the localized prostate cancer patient with single focus of biopsy-proven MRI-visible clinically significant cancer
Basic objectives2
Others
Basic objectives -Others
To demonstrate efficacy and safety of minimally invasive therapeutic option of targeted focal cryoablation to achieve cancer controle and maintaining of quality-of-life
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To achieve all of these 1),2), and 3):
1) 50% or greater in PSA dicrease rate from pre-op PSA to post-op PSA at post-op 3 or 6 months
2) 3 or less in PI-RADS actogry of the targeted MRI-lesion at post-op 6 months
3) Negative for cancer in the targeted prostate biopsies at post-op 6 months from the treated targeted-lesion
Key secondary outcomes
Patient reported quality-of-life by EPIC and EQ5D questionnaires
PSA change
PI-RADS category change
Prostate biopsy outcome (focused on Gleason score)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Percutaneous cryosurgery to target the prostate cancer lesion
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) MRI-visible single focus clinically significant cancer proven by prostate biopsy
2) T2a-T2cN0M0
3) Men aged 20-85
4) Men with informed consent
Key exclusion criteria
1) MRI-visible biopsy proven cancer with both Gleason 6 and PI-RADS catogry 3 or with both Gleason 8 and PI-RADS catogory 5
2) PSA >20ng/ml
3) 5mm or less in distance between cancer lesion and urethral sphinctre muscle
4) Any treatment for prostate cancer in the past
5) Any anti-androgen therapy for BPH
6) Patient who use pad for urinary incontinence
7) Active cancer in other organ
8) Patient who cannot undergo MRI-prostate
9) Difficulty of undergoing transrectal ultrasonography
10) Prothrombin time<50% or platelet count <<60,000/mm3
11) Attending physician determines that the ineligible
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ukimura |
Organization
Kyoto Prefectural Univeristy of Medicine
Division name
Urology
Zip code
602-8566
Address
Kawaramachi-Hirokoji, Kyoto, 602-8566
TEL
0752515595
ukimura@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Ukimura |
Organization
Kyoto Prefectural University of Medicine
Division name
Urology
Zip code
602-8566
Address
Kawaramachi-Hirokoji, Kyoto, 602-8566
TEL
0752515595
Homepage URL
https://www.KPUM-urology.com
ukimura@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kyoto Min-iren Cyuo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine IRB
Address
Kawamachi-Hirokoji, Kajiicyou 465, Kyoto, Japan
Tel
075-251-5595
rinri@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT2052210088
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
有り
Institutions
Institutions
京都府立医科大学附属病院 および 京都民医連中央病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
51
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This investigator initiated clinical trial has been published in jR CT (Japan Registry of Clinical Trials https://jrct.niph.go.jp) as the number of jRCT2052210088 (PROCRY) with some modifications from the contents of this page.
Date of First Enrollment: 2021/10/11
Sample Size: n=50
Management information
Registered date
| 2018 | Year | 05 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036994
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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