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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000959
Receipt No. R000001149
Scientific Title Combination therapy of the peptide vaccines and dexamethasone for hormone-refractory prostate cancer: Early phase II randomized controlled study
Date of disclosure of the study information 2008/01/01
Last modified on 2015/05/13

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Basic information
Public title Combination therapy of the peptide vaccines and dexamethasone for hormone-refractory prostate cancer: Early phase II randomized controlled study
Acronym Combination therapy of the peptide vaccines and dexamethasone for hormone-refractory prostate cancer
Scientific Title Combination therapy of the peptide vaccines and dexamethasone for hormone-refractory prostate cancer: Early phase II randomized controlled study
Scientific Title:Acronym Combination therapy of the peptide vaccines and dexamethasone for hormone-refractory prostate cancer
Region
Japan

Condition
Condition Progressive hormone-refractory prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Candidate peptide vaccines have been developed for the prostate cancer patients who have HLA-A2, HLA-A24, or HLA-A3 super type.
Of these peptides, we plan to use as vaccines those that have been recognized by the patient-specific immune system (serum IgG antibodies) or by the killer T-cell precursor (CTLp) in the peripheral blood.
If the patient is positive for two of the HLA super types, both candidate peptides will be selected as vaccines.
We will evaluate the safety and efficacy of combination therapy of peptide vaccines and dexamethasone compared with dexamethasone alone against prostate cancer patients by a prospective randomized controlled trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Progression-free survival
Objective response rate
Disease control rate
Safety profile

Evaluation will be performed on each evaluable lesion according to The Prostate Cancer Treatment Agreement in Japan (3rd edition. April, 2001).
When the patient does not have measurable lesions, the serum PSA level will be assessed in accordance with Bubley's criteria.
The initial evaluation will be performed 12 weeks after the initiation of treatment.
Key secondary outcomes Immune response:
Induction of cytotoxic T-lymphocytes and CTL-precursor cells.
Induction of the anti-peptide antibodies.
Immune response will be assessed by comparing the data from samples obtained before and after therapy administration.

QOL score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Combination of the peptides and dexamethasone:
Maximum of four kinds of peptide from those that have been recognized by the patient-specific immune system (serum IgG antibodies) or by the killer T-cell precursor (CTLp) in the peripheral blood will be selected as vaccines.
3mg of each peptide will be administrated separately.
The administration interval is essentially 2 weeks.
Dose reduction to 1 mg is allowed when a grade-3 adverse event of local skin response occur.

Dexamethasone 1 mg/day p.o. everyday is started on the first day of peptide administration.

Essentially, peptides and dexamethasone administration will be continued until disease progression or severe adverse events occur.
Interventions/Control_2 Dexamethasone alone:
Dexamethasone 1 mg/day p.o. everyday is started on the first day of peptide administration.
Essentially, dexamethasone administration will be continued until disease progression or severe adverse events occur.
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 Eligible patients must meet the following criteria:
1. Hormone-refractory prostate cancer patients who have been histologically diagnosed as prostate adenocarcinoma.
Hormone-refractory prostate cancer is defined as the disease that has progressed after remission by primary hormone therapy with antiandrogens and surgical or medical castration.
Patients should have at least one measurable lesion 2 cm or larger by X-ray or should have consecutively-rising PSA detected three or more times by at least two-week interval evaluation after reaching the nadir by primary hormone therapy.
Antiandrogen-withdrawal syndrome should be ruled out by ceasing the antiandrogen for at least six weeks.
LH-RH agonist (leuprolide acetate, Leuplin) administration should be continued to maintain serum testosterone within castration levels when surgical castration has not been performed.
2. Patients are positive for HLA-A2, HLA-A24, or HLA-A3 super types (A3, A11, A31, A33).
3. Patients who have IgG or killer T-cell precursor that respond to one or more peptides prepared as candidate vaccines in the peripheral blood before vaccine administration.
4. No adverse effects or events occurring as a resulted from prior treatment should be carried over. Four or more weeks are required to wash out the pretreatment drug.
5. The patients' performance status (ECOG) should be 0 or 1.
6. Expected survival time should be three months or greater.
7. Serum PSA less than 10.0ng/ml
8. Written consent of participation after thorough explanation regarding this trial is required.
Key exclusion criteria Any patient who falls under any of the following criteria is excluded as a candidate:
1. Patients who have any severe underlying medical condition such as severe active infection, cardiovascular disease, respiratory disease, renal dysfunction, immune dysfunction, blood coagulation disorder and so on.
2. Active double cancer.
3. Past history of severe allergic disease.
4. Patients previously treated with an adrenocortical steroid such as dexamethasone. Temporary use of a steroid against a non-prostate cancer related diseases, for example allergies, are not excluded.
5. Patients previously treated with systemic chemotherapy including Docetaxel and Cisplatin or radiotherapy against non-primary disease.
6. Hepatitis type B or C should be excluded.
7. Any patients disqualified by a study physician.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotsugu Uemura
Organization Kinki University School of Medicine
Division name Department of Urology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka, Japan
TEL 072-366-0221
Email huemura@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu Uemura
Organization Kinki University School of Medicine
Division name Department of Urology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka, Japan
TEL 072-366-0221
Homepage URL
Email huemura@med.kindai.ac.jp

Sponsor
Institute Department of Urology, Kinki University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Jikei University School of Medicine
Osaka University, Graduate school of Medicine
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 01 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
2007 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2015 Year 05 Month 13 Day
Date of closure to data entry
2015 Year 05 Month 13 Day
Date trial data considered complete
2015 Year 05 Month 13 Day
Date analysis concluded
2015 Year 05 Month 13 Day

Other
Other related information

Management information
Registered date
2007 Year 12 Month 28 Day
Last modified on
2015 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001149

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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