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

Email

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

Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name