Investigation of neoadjuvant chemohormonal therapy before robot-assisted radical prostatectomy for the patients with high-risk prostate cancer.

Phase 2

Recruiting

• Conditions: Prostate cancer

• Registration Number: JPRN-jRCTs061180057
• Lead Sponsor: Takenaka Atsushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 100

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.
11) Patient who wants to make a child in the future.
12) In addition, those whom the research responsibility doctor judged to be unsuitable as a research candidate.
13) Prostate cancer patient who is having hormone therapy already done for six months or more.
14) Patient who has four or more lymph node metastases in a pelvis.
15) Patient who has four or more distant metastases.
16) HBV-infected patients who are judged to be unsuitable for chemotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified