UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031566
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

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Basic information

Public title

Focal cryotherapy for prostate cancer, a prospective study

Acronym

Focal cryotherapy for localized prostate cancer

Scientific Title

Focal cryotherapy for prostate cancer, a prospective study

Scientific Title:Acronym

Focal cryotherapy for localized prostate cancer

Region

Japan


Condition

Condition

1 Localized prostate cancer
2 Local recurrent prostate 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 focal cryotherapy for localized prostate cancer and the local recurrent prostate cancer after definitive radiotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Biochemical recurrence free survival

Key secondary outcomes

(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


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

40 years-old <=

Age-upper limit

85 years-old >

Gender

Male

Key inclusion criteria

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.

Key exclusion criteria

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

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Shin
Middle name
Last name Egawa

Organization

Jikei University School of Medicine

Division name

Urology

Zip code

1058461

Address

3-25-8, Nishishinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Email

s-egpro@jikei.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Sasaki

Organization

Jikei University School of Medicine

Division name

Urology

Zip code

1058461

Address

3-25-8, Nishishinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Homepage URL

http://jikei-ur.umin.jp/

Email

hs06@jikei.ac.jp


Sponsor or person

Institute

Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Jikei Univerity 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

Jikei University IRB

Address

3-25-8, Nishishinbashi, Minato-ku Tokyo

Tel

0334331111

Email

rinri@jikei.ac.jp


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

慈恵医大附属病院


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 04 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


Results

Primary focal cryotherapy 1 case
Salvage focal cryotherapy 15 cases

Results date posted

2020 Year 03 Month 08 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events

None

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2017 Year 12 Month 17 Day

Date of IRB

2017 Year 09 Month 04 Day

Anticipated trial start date

2018 Year 02 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry

2026 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 04 Day

Last modified on

2023 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036042


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name