Phase II trial of neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate evaluating PSA failure free survival and safety for locally advanced prostate cancer

UMIN ID: UMIN000001660

Registered date:27/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 2009/02/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients receive neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate for 6 months and undergo radical prostatectomy.

Outcome(s)

• Primary Outcome: 1. biochemical-progression free survival 2. Safety
• Secondary Outcome: 1. Overall survival 2. Cause-specific survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male
• Exclude criteria: 1) patients with severe co-morbidity including uncontrollable cardiac, cerebral disease. 2) patients with serious liver dysfunction or serious blood disease. 3) patients with gastroenterial ulcer. 4) Patients who had hypersensitivity to Goserelin or Leuprorelin. 5) patients who fall under the followings: AST, ALT and ALP > 2.5 times upper limit of normal (ULN), Serum creatinine > 1.5 times ULN , Leukocyte count < 3,000/uL, Hemoglobin < 10.0g/dL, Platelet count < 75,000/uL 6) Patients with other cancer requiring treatment

Related Information

• Primary Sponsor: Hirosaki University Graduate School of Medicine
• Secondary Sponsor: none
• Source(s) of Monetary Support: none,none