UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026876
Receipt number R000030780
Scientific Title Evaluation of the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and determination of a suitable methodology for planar and SPECT imagings with 223Ra
Date of disclosure of the study information 2017/04/26
Last modified on 2022/04/11 12:15:29

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Basic information

Public title

Evaluation of the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and determination of a suitable methodology for planar and SPECT imagings with 223Ra

Acronym

Evaluation of the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and determination of a suitable methodology for planar and SPECT imagings with 223Ra

Scientific Title

Evaluation of the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and determination of a suitable methodology for planar and SPECT imagings with 223Ra

Scientific Title:Acronym

Evaluation of the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and determination of a suitable methodology for planar and SPECT imagings with 223Ra

Region

Japan


Condition

Condition

Castration-resistant prostate cancer with bone metastases

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the accumulation in 223Ra (Xofigo) therapy to patients with castration-resistant prostate cancer having bone metastases and to determine a suitable methodology for planar and SPECT imagings with 223Ra.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Planar and SPECT imagings in 223Ra (Xofigo) therapy.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

SPECT/CT

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

20 years-old <

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Adults

Key exclusion criteria

Children

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Katsuhiko
Middle name
Last name Kato

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Radiological and Medical Laboratory Sciences

Zip code

461-8673

Address

1-20, Daikominami 1-chome, Higashi-ku, Nagoya, Japan

TEL

052-719-1504

Email

katokt@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Katsuhiko
Middle name
Last name Kato

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Radiological and Medical Laboratory Sciences

Zip code

461-8673

Address

1-20, Daikominami 1-chome, Higashi-ku, Nagoya, Japan

TEL

052-719-1504

Homepage URL


Email

katokt@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Nagoya University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagoya University Hospital

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

Tel

052-741-2111

Email

center@med.nagoya-u.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



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 26 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


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

Enrolling by invitation

Date of protocol fixation

2017 Year 04 Month 01 Day

Date of IRB

2017 Year 06 Month 15 Day

Anticipated trial start date

2017 Year 06 Month 15 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 04 Month 05 Day

Last modified on

2022 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030780


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name