Castration-resistant prostate cancer
Conditions
Interventions
Oral intake of low dose estramustine phosphate (313.4mg or 156.7mg)
Sponsors
Kyoto University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Evidence of progressive disease during androgen deprivation therapy (LHRH analog with or without antiandrogen)(including a trial of anti-androgen withdrawal therapy) according to PCWG1 criteria for phase II trial 2) More than 6 weeks have passed after final antiandrogen therapy (this is not the case with patients who have received antiandrogen therapy less than 6 months) 3) PSA values should be more than 2ng/ml within 4 weeks before enrollment (The most recent data is employed) 4) All patients can be enrolled with or without previous docetaxel treatment 5) At least 4 weeks should be passed after surgery or radiation 6) Patients must have normal organ and marrow functions as defined below: Absolute white blood cell count greater than or equal to 3000/mcL Hemoglobin greater than or equal to 9g/dl Platelets greater than or to 75000/mcL AST less than or equal to 90IU/L ALT less than or equal to 100IU/L Creatinine less than or equal to 2.0mg/dl 7) ECOG performance status 0-2 8) Age greater than or equal to 20 years and less than 85 years at the time of enrollment 9) Patient must be able to understand and willing to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1) Patients who have had estramustine phosphate therapy (including other estrogen-based hormone therapy) 2) Patients with malignancy within 5 years except carcinoma in situ or other malignancies limited within visceral mucosa 3) History of phlebitis, pulmonary embolism, intracranial infarction and coronary diseases 4) History of severe heart disease and renal diseases 5) Patients with active peptic ulcer 6) Psychiatric illness that makes it undesirable for the subject to participate in the trial 7) Evidence of any other significant disorder that make it undesirable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response rate | — |
Countries
Japan
Contacts
Public ContactTakahiro Inoue
Kyoto University, Graduate School of Medicine Urology
Outcome results
None listed