JPRN-jRCTs061180057
Recruiting
Phase 2
Investigation of neoadjuvant chemohormonal therapy before robot-assisted radical prostatectomy for the patients with high-risk prostate cancer. - Neoadjuvant chemohormonal therapy for high-risk prostate cancer.
Takenaka Atsushi0 sites100 target enrollmentMarch 18, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Takenaka Atsushi
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) age \<\=75 years.
- •2\) Prostate cancer patients who will be received RARP
- •3\) Performance Status(PS:ECOG) 0\-1\.
- •4\) Total bilirubin level less than 1\.5 times the upper limit of normal.
- •AST/ALT(GOT/GPT) level less than 2\.5 times the upper limit of normal.
- •Serum creatinine level less than 1\.5 times the upper limit of normal.
- •Hgb level more than 8\.0g/dL, WBC level more than 3000/ul, Plt level more than 100,000/ul.
- •5\) High risk patients with the total score more than 6 point.
Exclusion Criteria
- •1\) Patient with the treatment history of docetaxel.
- •2\) Patient with deep vein thrombosis.
- •3\) Patient who has the past history of heart failure or myocardial infarction.
- •4\) Patient with the past history of interstitial pneumonia.
- •5\) An infectible patient.
- •6\) Patient with diabetes with difficult control.
- •7\) Patient who received medication of other investigational drugs within three months before the start of this study.
- •8\) Patient who already received radiotherapy for prostate cancer.
- •9\) Patient who is under treatment of other neoplasm except for the prostate cancer now.
- •10\) Patient who is using the medicine with a possibility that blood concentration may rise by combined use.
Outcomes
Primary Outcomes
Not specified
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