UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034795
Receipt number R000039684
Scientific Title Impact of local therapy for metastatic prostate cancer
Date of disclosure of the study information 2019/02/01
Last modified on 2018/11/07 10:28:44

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Basic information

Public title

Impact of local therapy for metastatic prostate cancer

Acronym

Impact of local therapy for metastatic prostate cancer

Scientific Title

Impact of local therapy for metastatic prostate cancer

Scientific Title:Acronym

Impact of local therapy for metastatic prostate cancer

Region

Japan


Condition

Condition

metastatic prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of local therapy for metastatic prostate cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Progression-free survival
PSA response
Objective response


Base

Study type

Interventional


Study design

Basic design

expanded access

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

Maneuver

Interventions/Control_1

Standard therapy + Operation or radiotherapy

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

Key inclusion criteria

Histologically proven adenocarcinoma of the prostate
Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
Clinical stage M1a (distant lymph node positive), or M1b (bone metastasis)
If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician)
No previous local therapy for prostate cancer
Give informed consent
Prostate deemed resectable by surgeon
Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Hemoglobin (HgB) >= 9 g/dL compatible for surgery
Platelets > 80,000 compatible for surgery
Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery

Key exclusion criteria

Refuses to give informed consent
Deemed to have unresectable disease by surgeon
Received ADT for more than 6 months prior to randomization
Life expectancy of less than 6 months prior to randomization
Known spinal cord compression
M1c disease (solid organ metastasis)
Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to randomization
Previous local therapy for prostate cancer
Previous chemotherapy for prostate cancer
Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier
Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shingo Hatakeyama

Organization

Hirosaki University School of Medicine

Division name

Urology

Zip code


Address

5 zaifu-chou, Hirosaki, Japan

TEL

0172395091

Email

shingoh@hirosaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shingo Hatakeyama

Organization

Hirosaki University School of Medicine

Division name

Urology

Zip code


Address

5 zaifu-chou, Hirosaki, Japan

TEL

0172395091

Homepage URL


Email

shingoh@hirosaki-u.ac.jp


Sponsor or person

Institute

Hirosaki University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2019 Year 02 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


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

Preinitiation

Date of protocol fixation

2018 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2019 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 11 Month 07 Day

Last modified on

2018 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039684


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name