Combination therapy of the peptide vaccines and dexamethasone for hormone-refractory prostate cancer: Early phase II randomized controlled study
- Conditions
- Progressive hormone-refractory prostate cancer
- Registration Number
- JPRN-UMIN000000959
- Lead Sponsor
- Department of Urology, Kinki University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 100
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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