Combination therapy of the peptide vaccines and dexamethasone for hormone-refractory prostate cancer: Early phase II randomized controlled study

UMIN ID: UMIN000000959

Registered date:01/01/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Progressive hormone-refractory prostate cancer
• Date of first enrollment: 2008/01/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
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.

Outcome(s)

• Primary Outcome: 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.
• Secondary Outcome: 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

Key inclusion & exclusion criteria

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

Related Information

• Primary Sponsor: Department of Urology, Kinki University School of Medicine
• Secondary Sponsor: Jikei University School of Medicine Osaka University, Graduate school of Medicine
• Source(s) of Monetary Support: None