UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004929 |
|---|---|
| Receipt number | 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 14:58:41 |
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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
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/
ynasu@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005867
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