A randomized controlled trial comparing personalized peptide vaccine plus low-dose estramustine with full dose estramustine for patients with hormone refractory prostate cancer

UMIN ID: UMIN000001096

Registered date:26/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 2006/06/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
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.

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male
• Exclude 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.

Related Information

• Primary Sponsor: Kurume University School of medicine, Department of Immunology
• Source(s) of Monetary Support: The Ministry of Education, Culture, Sports, Science, and Technology, Japan