UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study of adenovirus mediated Reduced Expression in Immortalized Cells/Dickkopf-3(REIC/Dkk-3)gene therapy for prostate cancer
Title of the study (Brief title)	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	Yasutomo Nasu
Organization	Okayama University
Division name	Department of Urology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address	2-5-1 Shikata Okayama city
TEL	086-235-7287
Email	ynasu@md.okayama-u.ac.jp

Public contact
Name of contact person	Yasutomo Nasu
Organization	Okayama University
Division name	Department of Urology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 12 Month 22 Day
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

Related information
URL releasing protocol	http://www.uro.jp/okayama/
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005867