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

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034906
Enrollment
100
Registered
2018-11-16
Start date
2018-11-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Docetaxel

Sponsors

Tottori University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion 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 according to our scoring system. In addition, also in the cases of less than six sum total score, we incorporate the following patients. The patients who have the lymph node metastasis up to three pieces in the regional lymphnode in a pelvis, or the patients who have bone metastasis up to three pieces.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Pathological outcome

Secondary

MeasureTime frame
PSA recurrence rate after prostatectomy

Countries

Japan

Contacts

Public ContactMorizane Shuichi

Tottori University Hospital Urology

morizane@tottori-u.ac.jp0859-38-6607

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026