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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001096
Receipt No. R000001326
Scientific Title A randomized controlled trial comparing personalized peptide vaccine plus low-dose estramustine with full dose estramustine for patients with hormone refractory prostate cancer
Date of disclosure of the study information 2008/03/26
Last modified on 2010/04/05

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Basic information
Public title A randomized controlled trial comparing personalized peptide vaccine plus low-dose estramustine with full dose estramustine for patients with hormone refractory prostate cancer
Acronym Randomized trial of peptide vaccination for hormone-refractory prostate cancer patients
Scientific Title A randomized controlled trial comparing personalized peptide vaccine plus low-dose estramustine with full dose estramustine for patients with hormone refractory prostate cancer
Scientific Title:Acronym Randomized trial of peptide vaccination for hormone-refractory prostate cancer patients
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the anti-tumor effect and safety of personalized peptide vaccine plus low-dose estramustine with full dose estramustine for HLA-A2 and –A24 positive patients with hormone refractory prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes 1. adverse events
2. overall survival
3. Subjective effects (pain due to metastatic lesion, symptoms based on urinary disturbance due to primary lesion, PS, progression of cancer / change of body weight according to improvement) and evaluation of quality of life based on FACT examination sheet.
4. Evaluation of immunological responses (cytotoxic T lymphocytes (CTL), CTL precursors, anti-peptide IgG) before and after peptide vaccination.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A: Select peptide candidates (up to 4), to which CTL precursors or 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 2 weeks interval. Start internal use of estramustine 2 cap (2X) (280 mg/day) on the same day with peptide vaccination.
After PD(Three consecutive and 125% increase from baseline PSA levels at least two weeks apart), patients are treated with B regime.
Interventions/Control_2 B: Full dose of estramustine alone (4 cap 2X, 560 mg/day)
After PD(Three consecutive and 125% increase from baseline PSA levels at least two weeks apart), patients are treated with A regime.
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
80 years-old >
Gender Male
Key inclusion criteria The subjects must satisfy the following conditions.
1)Patients must be diagnosed as prostate cancer pathologically after the treatment of castration, LH-RH analogue therapy, anti-andorogen therapy, or female hormone therapy. The patients must be suffering from hormone refractory prostate cancer(#1,2,3,4)
#1: The measurable tumor size must be more than 2 cm by X-ray and the level of PSA must increase more than 3 times consecutively at more than 2 weeks interval.
#2: Patients must be drug-free more than 4 weeks after hormone therapies or chemotherapies. The hormone withdrawal syndrome must be ruled out.
#3: In the cases of patients without castration, the LH-RH analogue therapy will be continued to keep the level of testosterone.
#4: Patients must not receive the treatment with bisphosphonate and steroid.
2) Patients must be positive for HLA-A2 or HLA-A24.
3) Patients must have IgG reactive to at least one of peptide candidates.
4) When patients had received pre-therapies, including chemotherapy, immunotherapy, and radiation therapy, the vaccine therapy must be started at least more than 4 weeks after the last therapy. Patients showing anti-tumor effects or adverse effects of pre-therapy must be excluded.
5) Patients must be at a score level
of 0-1 of performance status (PS) (ECOG).
6) Patients must be expected to survive more than 3 months.
7) Patients must satisfy the followings:
WBC >= 3,000/mm3
(Lymphocyte >= 1,200/mm3)
Hb >= 9.0 g/dl
Platelet >= 100,000 /mm3
Serum Creatinine <= 1.4 mg/dl
Total Bilirubin <= 1.5 mg/dl
8) Patients must be negative for Hepatitis virus B/C.
9) Patients must be more 20 year-old and less 80 year-old.
10) 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) Patients with multiple cancers
3) Patients with the past history of severe allergic reactions.
Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Noguchi
Organization Kurume University School of Medicine
Division name Department of Urology
Zip code
Address Asahi-machi 67, Kurume,
TEL 0942-31-7572
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamada
Organization Kurume University School of Medicine
Division name Research Center of Innovative Cancer Therapy, Cancer Vaccine Department Division
Zip code
Address Research Center of Innovative Cancer Therapy, Cancer Vaccine Department Division
TEL 0942-31-7744
Homepage URL
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of medicine, Department of Immunology
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)

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

Other administrative information
Date of disclosure of the study information
2008 Year 03 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

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
2006 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 03 Month 25 Day
Last modified on
2010 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001326

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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