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

JRCT ID: jRCTs061180057

Registered date:18/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 19/12/2016
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Neoadjuvant hormonal chemotherapy
Patients do oral internal use of 80 mg of Bicalutamide for seven months every day. Patients receive the subcutaneous administration of a LHRH drug product . Three months after a treatment start, patients use together the docetaxel of three courses with predonizorone therapy. Patients receive intravenous drip of docetaxel 70 mg/m2 for 1 hour or more as 1 corse for four weeks.
Patients take predonizorone twice per day at 5 mg once as a concomitant drug.

Outcome(s)

Primary Outcome

1) Pathological assessment of removal prostate tissue.
the percentage of positive resection margin, Tumor disappearance rate
2) The postoperative PSA recurrence-free rate

• Secondary Outcome: The assessment of the frequency of the side effects according to the neoadjuvant hormonal chemotherapy.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 75age old
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Takenaka Atsushi
• Secondary ID(s): UMIN000034906