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Clinical Trials/JPRN-jRCTs061180057
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.

Registry
who.int
Start Date
March 18, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Takenaka Atsushi

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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