UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study of an oncolytic herpes simplex type 1 (HSV-1) G47delta for patients with castration resistant prostate cancer
Title of the study (Brief title)	A clinical study of an oncolytic HSV-1 G47delta for patients with castration resistant prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	Primary: To assess the safety of G47delta administered into the prostate in subjects with castration resistant prostate cancer. Secondary: To assess the efficacy of G47delta by the level of PSA .
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Safety -Spectrum and frequency of adverse events
Key secondary outcomes	Efficacy -Change in PSA levels

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The administration of an oncolytic HSV-1 G47delta
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	Not applicable
Gender	Male
Key inclusion criteria	In this single-armed phase I study, patients with prostate cancer that had not received prostatectomy and recurred after hormonal therapy are registered. Both of those with and without prior record of chemotherapy, and both of those with and without remote metastases are included.
Key exclusion criteria	-Administration of other clinical study drugs within 30 days of G47delta administration -Known HIV seropositivity -Current diagnosis of any medical or psychological condition that might interfere with the subject's ability to participate -Blood test results outside protocol specified limits -Evidence of active herpes infection -Current diagnosis of any active malignant tumor -Active uncontrolled infection that precludes surgery -History of alcohol or other drug abuse -Allergy to anti-HSV drug (acyclovir) -Administration of any anticancer drugs within 30 days of G47delta administration -Administration of any anti-androgen drugs within 30 days of G47delta administration -Conditions considered inadequate for the subject to be enrolled in the study
Target sample size	9

Research contact person
Name of lead principal investigator	Hiroshi Fukuhara
Organization	The University of Tokyo
Division name	Urology
Address	7-3-1 Hongo, Bunkyo-ku Tokyo
TEL	03-5800-8753
Email	hfukuhara-jua@umin.ac.jp

Public contact
Name of contact person	Hiroshi Fukuhara
Organization	The University of Tokyo Hospital
Division name	Translational Research Center
Address	7-3-1 Hongo, Bunkyo-ku Tokyo
TEL	03-5800-9072
Homepage URL
Email	TRC@h.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science and Technology The University of Tokyo Hospital Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 19 Day
Anticipated trial start date	2013 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 10 Day
Last modified on	2016 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012228