prostate cancer
Conditions
Interventions
Neoadjuvant chemo-hormonal therapy using estramustine phosphate and luteinizing hormone-releasing hormone (LHRH) antagonists/antagonist
Sponsors
Hirosaki University School of Medicine Dept. of Urology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Men with high-risk prostate cancer (Gleason score >7, cT2c, or PSA>20 ng/mL) who is indicated for radical prostatectomy
Exclusion criteria
Exclusion criteria: History of severe cardiac conditions, such as angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study. History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1. Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to neoadjuvant therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical recurrence free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| progression for castration-resistant-prostate cancer (CRPC), overall survival, Safety | — |
Countries
Japan
Contacts
Public ContactShingo Hatakeyama
Hirosaki University School of Medicine Urology
Outcome results
None listed