Docetaxel resistant castration resistant prostate cancer
Conditions
Interventions
ribavirin orally administered twice a day (after breakfast and dinner) for maximum 105 days as following dosage Body weight:Daily dose <
=60 kg: 600 mg >
60,<
=80 kg: 800 mg >
80 kg: 1000 mg
Sponsors
Department of Urology,Keio University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Patients aged 30 years or older on obtaining informed consent. However, those (in-/outpatients) aged 75 years or older who are not considered eligible by the chief investigator are excluded. 2.Those with a will to sign the informed consent document who are able to sign it 3.Those histopathologically diagnosed with prostate cancer 4.Those with castration-resistant prostate cancer 5.Those with exacerbation during or after docetaxel therapy Those with one of the following findings are regarded as showing exacerbation: 1)An increase in the serum PSA level on 2 consecutive blood tests 2)PD evaluated according to the RECIST on diagnostic imaging in patients with measurable lesions 3)Marked enlargement of metastatic foci or appearance of new foci on bone scintigraphy 6.Those who recently received docetaxel therapy 7.Those with a PSA level of more than 2 ng/mL during the screening period 8.Those with no plan of new treatment for prostate cancer during the trial period 9.Those with an Easten Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 10.Those whose life expectancy is expected to be more than 12 weeks by the chief investigator or attending physicians 11.Those with favorable blood/liver/kidney functions meeting the following criteria during the screening period Item:Criterion Hemoglobin:not less than 11.0 g/dL AST and ALT:below 60 IU/L Leukocyte count:not less than 3000/microL Serum creatinine:not more than 1.5 mg/dL Neutrophil count:not less than 1500 /microL Serum potassium:not less than 3.5 mEq Platelet count:not less than 75000/microL Serum albumin:not less than 3.0 g/dL Total bilirubin:not more than 2.5xULN 12.Those consenting to contraception from signing the informed consent document until 6 months after the completion of investigational-drug administration
Exclusion criteria
Exclusion criteria: 1.Patients with a history of hypersensitivity to the components of ribavirin or other antiviral drugs (aciclovir, ganciclovir, or vidarabine) who are not considered eligible by the chief investigator 2.Those who are to receive aciclovir or paclitaxel within 7 days before the start of investigational-drug administration 3.Those with serious complications other than prostate cancer on obtaining informed consent 4.Those with double cancer in whom the interval from previous treatment is <5 years on obtaining informed consent 5.Those participating in another trial on obtaining informed consent 6.Those receiving cabazitaxel 7.Others who are not considered eligible by the chief investigator or attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of adverse events/reactions and their grade | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA effects: 30% response rate (>=30% decrease), 50% response rate (>=50% decrease) Response rate (evaluated according to the RECIST in patients with measurable lesions) QOL assessment (FACT-P, EQ-5D) Diagnostic imaging Blood concentrations of drugs: Changes in the blood concentrations of ribavirin, docetaxel, and prednisolone Exploratory items: Changes in blood markers(ALP, leptin, IL-1, and IFN-gamma) CTC count and marker expression, blood DNA | — |
Countries
Japan
Contacts
Public ContactYasuko Saito
Keio University Hospital Clinical and Translational Research Center
Outcome results
None listed