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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004929
Receipt No. R000005867
Scientific Title A clinical study of adenovirus mediated Reduced Expression in Immortalized Cells/Dickkopf-3(REIC/Dkk-3)gene therapy for prostate cancer
Date of disclosure of the study information 2011/01/24
Last modified on 2018/07/30

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Basic information
Public title A clinical study of adenovirus mediated Reduced Expression in Immortalized Cells/Dickkopf-3(REIC/Dkk-3)gene therapy for prostate cancer
Acronym Prostate cancer gene therapy using REIC
Scientific Title A clinical study of adenovirus mediated Reduced Expression in Immortalized Cells/Dickkopf-3(REIC/Dkk-3)gene therapy for prostate cancer
Scientific Title:Acronym Prostate cancer gene therapy using REIC
Region
Japan North America

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This is a Phase I, open-label, dose-escalation trial in patients with advanced prostrate cancer refractory to standard therapy and scheduled to undergo a radical prostatectomy.
Primary Objective:
To assess the safety of in-situ therapy with the REIC/Dkk-3 gene in patients with advanced prostate cancer.
Secondary Objective:
To study the in vivo pharmacology and effectiveness of the REIC/Dkk-3 gene therapy as measured by; (a) Morphologic and cytotoxic changes in the specimen of a systemic transrectal prostate biopsy after treatment, and (b) to assess the local and systemic immune-stimulatory activity
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Tolerability:
Performance Status
CBC (including platelets, fibrinogen, SGPT, lactic dehydrogenase)
Adverse events (AEs)
Physical examination (PE)
Vital signs (VS)
Clinical laboratory values
Key secondary outcomes Post-radical prostatectomy evaluation
PSA
lymphocyte analysis using FCM(3days, 1,2,4 week)


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 1.0x10E10 virus particle
Interventions/Control_2 1.0x10E11 virus particle
Interventions/Control_3 1.0x10E12 virus particle
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
75 years-old >=
Gender Male
Key inclusion criteria A)Hormone refractory prostate cancer
Patient with non metastatica case. PSA rising after definitive hormonal therapy

Patinet with metastatic case
Patients who are diagnosed asmetastatic disease at the time of initial diagnosis.
Patient who become metastatic disease after radical prostatectomy in spite of hormonal therapy.

B)Newly diagnosed localized prostate cancer who will receive prostatectomy
Patient with high risk of reccurrence after operation
Key exclusion criteria 1 Uncontrolled infectious disease
2 Patient who received clinical trial
3 Concomitant malingant disese. Interval of NED is exceptional
4 Patient who had a histor of withdrawal from this trial
5 Patient who are considered by investigator as unappropriate for this trial
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasutomo Nasu
Organization Okayama University
Division name Department of Urology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address 2-5-1 Shikata Okayama city
TEL 086-235-7287
Email ynasu@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasutomo Nasu
Organization Okayama University
Division name Department of Urology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address 2-5-1 Shikata Okayama city
TEL 086-235-7287
Homepage URL http://www.uro.jp/okayama/
Email ynasu@md.okayama-u.ac.jp

Sponsor
Institute Okayama University hospital
Institute
Department

Funding Source
Organization Okayama University hospital
Organization
Division
Category of Funding Organization Other
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 岡山大学病院(岡山)
Okayama University Hospital(OKAYAMA)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 24 Day

Related information
URL releasing protocol http://www.uro.jp/okayama/
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 No longer recruiting
Date of protocol fixation
2010 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 01 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
2011 Year 01 Month 22 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005867

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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