UMIN-CTR Clinical Trial

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

Prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Kurume University School of medicine, Department of Immunology

Institute

Department

Personal name

Organization

The Ministry of Education, Culture, Sports, Science, and Technology, Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

03

Month

26

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2008

Year

03

Month

25

Day

Last modified on

2010

Year

04

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001326