castration resistant prostate cancer
Conditions
Interventions
Group A: to add antiandrogen or substitute antiandrogen until disease progression
Group B: to combine adding antiandrogen or substitution of antiandrogen with tegafur-uracil until disease progressio
Sponsors
Department of Urology, Institute of Health Biosciences, The University of Tokushima Graduate School
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.pathologicaly confirmed prostate cancer 2.relapsed after LH-RH analogue/castration/maximum androgen blockade 3.AWS is confirmed 4.PS(ECOG)0-2 5.life expectancy of at least 3 month 6.general condition is enough and to satisfy the next condition Hb:more than 10.0g/dL WBC:more than 4,000/mm3 and below 12,000/mm3 Neutrophil count:more than 2,000/mm3 Platelet:more than 100,000/mm3 AST,ALT:under 100 IU/L T-Bilirubin:under 1.5 mg/dL creatinine:under 1.5 mg/dL nomal ECG 7.specimens obtained by prostate biopsy are available 8.written informed concent 9.ingestion is possible
Exclusion criteria
Exclusion criteria: 1.past history of radiotherapy or prostatectomy 2.past history of allergic reactions 3.use phenytoin 4.contraindication of tegafur-uracil 5.active infection 6.serious complications 7.other cancer requiring treatment 8.judged inappropriate for the clinical trial by doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to PSA progression, survival, adverse events, the correlation of mRNA expression of enzymes that are involved with 5-FU with anti-tumor effect | — |
Countries
Japan
Contacts
Public ContactMasayuki Takahashi
Institute of Health Biosciences, The University of Tokushima Graduate School Department of Urology
Outcome results
None listed