Unique ID issued by UMIN | UMIN000031566 |
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Receipt number | R000036042 |
Scientific Title | Focal cryotherapy for prostate cancer, a prospective study |
Date of disclosure of the study information | 2018/03/04 |
Last modified on | 2023/03/19 13:59:19 |
Focal cryotherapy for prostate cancer, a prospective study
Focal cryotherapy for localized prostate cancer
Focal cryotherapy for prostate cancer, a prospective study
Focal cryotherapy for localized prostate cancer
Japan |
1 Localized prostate cancer
2 Local recurrent prostate cancer after definitive radiotherapy
Urology |
Malignancy
NO
To assess the efficacy and safety of focal cryotherapy for localized prostate cancer and the local recurrent prostate cancer after definitive radiotherapy.
Safety,Efficacy
Others
Others
Not applicable
Biochemical recurrence free survival
(1) Overall survival
(2) Clinical progression free survival
(3) Prostate cancer specific survival
(4) Salvage treatment free survival
(5) biopsy results
(6) Adverse events
(7) QOL analysis
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Cryosurgery
40 | years-old | <= |
85 | years-old | > |
Male
1. Localized prostate cancer
1)Gleason score, under7
2) PSA <20ng/ml
3) Clinically significant cancer proven by MRI/US fusion biopsy and mltiparametric MRI imaging.
4) Except for targeted lesion, no MRI findings and Biopsy gleason score by transperineal saturation biopsy is under 6
5) Clinical T stage <T3a
2. Radiorecurence prostate cancer
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) No hormone therapy before recurrence.
1) Active cancer in other organ
2) Uncontrol HT, DM and ischmic heart disease
3) Severe brain disease
4) Collagen disease
5) uncontroled DM
6) uncontroled heart disease
7) The prostatectomy was performed before
6) Using steroid drug, excluding ointment
8) Attnding physician determines that the ineligible
60
1st name | Shin |
Middle name | |
Last name | Egawa |
Jikei University School of Medicine
Urology
1058461
3-25-8, Nishishinbashi, Minato-ku, Tokyo
03-3433-1111
s-egpro@jikei.ac.jp
1st name | Hiroshi |
Middle name | |
Last name | Sasaki |
Jikei University School of Medicine
Urology
1058461
3-25-8, Nishishinbashi, Minato-ku, Tokyo
03-3433-1111
http://jikei-ur.umin.jp/
hs06@jikei.ac.jp
Jikei University School of Medicine
Jikei Univerity School of Medicine
Self funding
Jikei University IRB
3-25-8, Nishishinbashi, Minato-ku Tokyo
0334331111
rinri@jikei.ac.jp
NO
慈恵医大附属病院
2018 | Year | 03 | Month | 04 | Day |
Unpublished
Primary focal cryotherapy 1 case
Salvage focal cryotherapy 15 cases
2020 | Year | 03 | Month | 08 | Day |
None
Open public recruiting
2017 | Year | 12 | Month | 17 | Day |
2017 | Year | 09 | Month | 04 | Day |
2018 | Year | 02 | Month | 01 | Day |
2026 | Year | 03 | Month | 31 | Day |
2026 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 04 | Day |
2023 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036042
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