Prostatic Neoplasms, Castration-Resistant
Conditions
Interventions
Sponsors
Yoshida Soichiro
Fujii Yasuhisa
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients with all of the following conditions will be eligible 1. 20 years of age or older and able to provide informed consent. 2. histologically or cytologically confirmed prostate cancer, without neuroendocrine, signet ring cell or small cell carcinoma 3. androgen deprivation therapy with GnRH agonist/antagonist or previous bilateral orchiectomy (drug or surgical castration) during the study period 4. testosterone level of less than 50 ng/dL at screening 5, patients with progressive disease who are on androgen deprivation therapy at the time of inclusion (disease progression is defined as three or more PSA increases at intervals of at least one week) 6, patients with a recent PSA level of 2 ng/mL or higher 7, PSA doubling time is less than 10 months 8. patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 9. patients expected to survive for at least 1 year 10. patients with prostate and/or pelvic lymph node involvement confirmed by CT, MRI or bone scintigraphy performed as routine care within 3 months (prostate lesions are confirmed by MRI) 11. patients who are willing and able to follow the study protocol, including follow-up visits and examinations.
Exclusion criteria
Exclusion criteria: A person is ineligible if he meets any of the following criteria. 1. patients who have received cytotoxic chemotherapy, aminoglutethimide, ketoconazole, olaparib, abiraterone acetate or enzalutamide for the treatment of prostate cancer 2. patients who have used the study drug within 4 weeks of the study start date 3. patients with a history of invasive cancer other than prostate cancer within 3 years of the study start date 4. patients with bone metastasis, visceral metastasis or distant lymph node metastasis confirmed by CT, MRI or bone scintigraphy performed as routine medical care within 3 months 5. neutrophil count less than 1,000,000/L, platelet count less than 100 x 1000,000,000/L and hemoglobin less than 10g/dL at screening 6. patients with total bilirubin more than 1.5 times the upper limit of normal (ULN), ALT and AST more than 2.5 times ULN at screening 7, patients with creatinine greater than 2 mg/dL at screening. 8, patients with albumin less than 3.0 g/dL at screening. 9, patients with a history of convulsive seizures or conditions that precipitate convulsive seizures. 10, patients with clinically significant cardiovascular disease. 11, patients with gastrointestinal diseases that affect absorption 12, patients who have undergone major surgery within 4 weeks of the study start date. 13. patients with hypersensitivity to the pharmaceutical ingredients, including labrasol, butylated hydroxyanisole, and butylated hydroxytoluene 14. patients with conditions or circumstances that, in the judgment of the investigator, would place the patient at undue risk, interfere with the completion of the study, or interfere with the analysis of the study results 15, patients with a history of prior irradiation of the intended target therapy site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA-progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Failure-free survival Time to radiological progression Changes in PSA Change in QOL | — |
Contacts
Public ContactSoichiro Yoshida
Tokyo Medical and Dental University
Outcome results
None listed