A Placebo Controlled Phase III Double Blind Study of ITK-1 in Patients with Prostate Cancer - A Clinical Evaluation of ITK-1 in Castration-Resistant, Docetaxel Refractory Prostate Cancer Patients with HLA-A24 positive <Confirmatory Study> -

A Placebo Controlled Phase III Double Blind Study of ITK-1 in Patients with Prostate Cancer - A Clinical Evaluation of ITK-1 in Castration-Resistant, Docetaxel Refractory Prostate Cancer Patients with HLA-A24 positive <Confirmatory Study> - - A Placebo Controlled Phase III Double Blind Study of ITK-1 in Patients with Prostate Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011308

Enrollment

333

Registered

2013-08-01

Start date

2013-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

ITK-1 group : Peptide vaccine (3mg/1.5mL) with selected 2 to 4 are injected subcutaneously once weekly in total 6 times. After that, study drugs are subcutaneously injected biweekly 30 times in total.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Written Informed Consent 2. HLA-A24 positive 3. Showing immune response to 2 or more out of 12 ITK-1 peptides 4. Diagnosed prostate cancer histopathologically 5. Met both criteria below for the treatment of prostate cancer. 1) Disease progression confirmed after the hormone therapy or the maximum androgen blockade (MAB) therapy 2) Disease progression confirmed after the treatment with docetaxel 6. Maintains castration status with 50 ng/dL (0.5 ng/mL) or less serum testosterone level 7. Serum PSA level >= 2 ng/mL 8. ECOG performance status of 0 or 1 9. Expected to survive more than 12 weeks 10. Adequate organ function 11. Agreed to perform contraception during the period from giving informed consent to 70 days after completion of administration of study drugs

Exclusion criteria

Exclusion criteria: 1.Received the Taxane antitumor agents except for Docetaxcel 2. Hypersensitivity to mineral oil or mannitol oleate 3. Severe complications 4. Active multiple cancers 5. Received ITK-1 in the past 6. Entry to the other clinical trial within 2 months prior to entry to this study 7. Difficult to participate in this trial because of psychiatric symptoms 8. The patient who is suspected to suffer from any improper disadvantages by not participating in this study 9. Any other cases who are judged as being ineligible for this study by physician

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
1.Survival rate at 12 months 2.Serum prostate specific antigen (PSA) level 3.Anti-peptide antibody titer 4.Cytotoxic T lymphocyte activity 5.Frequency of adverse reactions and adverse events	—

Countries

Japan

Contacts

Public ContactShogo Hirota

BrightPath Biotherapeutics Co., Ltd. Pharmaceutical Development Dept.

hirota_s@brightpathbio.com03-5840-7697

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

A Placebo Controlled Phase III Double Blind Study of ITK-1 in Patients with Prostate Cancer - A Clinical Evaluation of ITK-1 in Castration-Resistant, Docetaxel Refractory Prostate Cancer Patients with HLA-A24 positive &lt;Confirmatory Study&gt; -