Unique ID issued by UMIN | UMIN000027608 |
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Receipt number | R000031638 |
Scientific Title | Neoadjuvant chemo-hormonal therapy for high-risk prostate cancer |
Date of disclosure of the study information | 2017/06/02 |
Last modified on | 2022/12/05 22:10:31 |
Neoadjuvant chemo-hormonal therapy for high-risk prostate cancer
Neoadjuvant chemo-hormonal therapy for high-risk prostate cancer
Neoadjuvant chemo-hormonal therapy for high-risk prostate cancer
Neoadjuvant chemo-hormonal therapy for high-risk prostate cancer
Japan |
prostate cancer
Urology |
Malignancy
NO
Investigate clinical benefit of neoadjuvant chemo-hormonal therapy for high-risk prostate cancer
Safety,Efficacy
Biochemical recurrence free survival
progression for castration-resistant-prostate cancer (CRPC), overall survival, Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
Neoadjuvant chemo-hormonal therapy using estramustine phosphate and luteinizing hormone-releasing hormone (LHRH) antagonists/antagonist
20 | years-old | < |
90 | years-old | >= |
Male
Men with high-risk prostate cancer (Gleason score >7, cT2c, or PSA>20 ng/mL) who is indicated for radical prostatectomy
History of severe cardiac conditions, such as angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to neoadjuvant therapy
1000
1st name | Shingo |
Middle name | |
Last name | Hatakeyama |
Hirosaki University School of Medicine
Urology
036-8562
5 zaifu-chou, Hirosaki Japan
0172395091
shingoh@hirosaki-u.ac.jp
1st name | Shingo |
Middle name | |
Last name | Hatakeyama |
Hirosaki University School of Medicine
Urology
036-8562
5 zaifu-chou, Hirosaki Japan
0172395091
shingoh@hirosaki-u.ac.jp
Hirosaki University School of Medicine
Dept. of Urology
Hirosaki University Graduate School of Medicine
Other
Japan
Hirosaki University School of Medicine
Hirosaki
0172-39-5044
rinri@hirosaki-u.ac.jp
NO
2017 | Year | 06 | Month | 02 | Day |
Published
516
he inverse probability of treatment weighting-Cox analysis revealed limited PLND had no significant impact on BCR-FS (hazard ratio, 1.44; P = 0.469). Limited PLND during RP after neoadjuvant chemohormonal therapy showed quite low rate of positive nodes, higher rate of complications, and no significant impact on BCR-FS.
2022 | Year | 12 | Month | 05 | Day |
Completed
2005 | Year | 03 | Month | 31 | Day |
2021 | Year | 04 | Month | 30 | Day |
2005 | Year | 04 | Month | 01 | Day |
2022 | Year | 12 | Month | 05 | Day |
2017 | Year | 06 | Month | 02 | Day |
2022 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031638
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