UMIN-CTR Clinical Trial

Basic information
Public title	A phase II randomized clinical trial of personalized peptide vaccination in combination with Japanese herbal medicines for castration-resistant prostate cancer (CRPC)
Acronym	Personalized peptide vaccination with Japanese herbal medicines for CRPC
Scientific Title	A phase II randomized clinical trial of personalized peptide vaccination in combination with Japanese herbal medicines for castration-resistant prostate cancer (CRPC)
Scientific Title:Acronym	Personalized peptide vaccination with Japanese herbal medicines for CRPC
Region	Japan

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

Objectives
Narrative objectives1	The aim of study is to investigate the immunity-enhancing effects, safety , clinical efficacy of personalized peptide vaccination in combination with Japanese herbal medicines (hochuekkito and keishibukuryogan) for castration-resistant prostate cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Comparison of immune-enhancing effects between two groups.
Key secondary outcomes	1. Comparison of peptide-specific CTL responses in PBMCs between two groups. 2. Comparison of safety between two groups. 3. Comparison of overall survival between two groups .

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	A: Personalized peptide vaccination with oral herbal medicines treatment. Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5-3.0 ml/peptide) every 1 week interval. Start oral use of hochuekkito (7.5g/day, 3X, 50 days) and keishibukuryougan (7.5g/dau, 3X, 50 days) on the same day with peptide vaccination. 1st treatment: total 8 times, every weeks) If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue (every 2-4 weeks) until unacceptable toxicity or withdrawal of consent.
Interventions/Control_2	B: Personalized peptide vaccine alone Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5-3.0 ml/peptide) every 1 week interval. If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue (every 2-4 weeks) until unacceptable toxicity or withdrawal of consent.
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	85 years-old >
Gender	Male
Key inclusion criteria	The subjects must satisfy the following conditions. 1) Patients must be diagnosed as prostate cancer pathologically at the initial treatment. The patients must be suffering from castration-resistant prostate cancer after standard treatment. 2) Patients must be at a score level of 0-1 of performance status (PS) (ECOG). 3) Patients must be positive for HLA-A2, HLA-A24, HLA-A26 or HLA-A3 super type. 4) Patients must have IgG reactive to at least two of peptide the candidate peptides restricted to the patient's HLA types. 5) If patients have used previously hochuekkito and/or keishibukuryougan, patients must wait a treatment for 4 weeks. 6) Patients must be expected to survive more than 3 months. 7) Patients must satisfy the followings: WBC >and= 2,500/mm3 Lymphocyte >and=1,000/mm3 Hb >and= 8.0g/dl Platelet >and= 100,000/mm3 Serum Creatinine <and= 2.5x upper limit of normal Total Bilirubin <and=2x upper limit of normal 8) Patients must be more 20 year-old. 9) Written informed consent must be obtained from patients.
Key exclusion criteria	The following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 2) Patients with the past history of severe allergic reactions. 3) Patients who are judged inappropriate for the clinical trial by doctors. 4) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 5) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masanori Noguchi
Organization	Kurume University School of Medicine
Division name	Research Center for Innovative Cancer Therapy, Division of Clinical Research
Zip code
Address	Asahi-machi 67, Kurume,
TEL	0942-31-7989
Email	noguchi@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akira Yamada
Organization	Kurume University School of Medicine
Division name	Research Center for Innovative Cancer Therapy, Division of Cancer Vaccine
Zip code
Address	Asahi-machi 67, Kurume,
TEL	0942-31-7572
Homepage URL
Email	noguci@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University School of medicine, Department of Immunology and Immunotherapy
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	Kurume University

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	久留米大学医療センター(福岡県) Kurume University Medical Center(Fukuoka)

Other administrative information
Date of disclosure of the study information	2013 Year 04 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	Completed
Date of protocol fixation	2012 Year 11 Month 19 Day
Date of IRB	2012 Year 11 Month 19 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 03 Month 21 Day
Last modified on	2019 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012051