Patients with previously untreated metastatic high-risk prostate cancer who had just started initial hormonal therapy were eligible to undergo robotic-assisted laparoscopic radical prostatectomy (RALP).
Men under the age of 80 as an indication for RALP surgery.
In 2019, the first case obtained informed consent for this study, and RALP was performed after docetaxel chemotherapy (No.1),
In 2020, informed consent was obtained for the second case, and although docetaxel chemotherapy was performed, RALP was not performed because the subject chose radical irradiation instead of RALP (No.2).
As a background, we recruited target patients who could be indicated for RALP surgery in cases with a relatively small amount of metastasis because the indication for surgical treatment of the primary lesion for advanced prostate cancer with a large amount of metastasis is low.
New androgen receptor inhibitors (abiraterone Zytiga, apalutamide Erleada, enzalutamide Xtandi) were previously only covered by insurance for castration-resistant prostate cancer. However, just at the time when this study was started, these medicines were approved for expanded insurance coverage for patients with hormone-naive metastatic prostate cancer, who are the target patients for this study. For this reason, many patients chose new androgen receptor inhibitors instead of docetaxel chemotherapy. it was difficult to obtain informed consent from patients for this research.
In case No. 1, the following adverse events occurred after docetaxel chemotherapy, but the causal relationship with docetaxel chemotherapy was not considered to be strong, and the symptoms were mild and spontaneously recovered.
Event Time of onset
1 Nausea/vomiting 2019/7/24
In case No. 1, the following adverse events were observed during the hospital stay after surgery. However, these were after RALP surgery and were minor, commonly seen in routine pelvic surgery, and docetaxel chemotherapy, which is characteristic of this study, is not causally related to the cause of these adverse events. thought.
Event Time of onset
1 Wound pain, decreased SoO2 2019/11/28
2 Lower extremity edema 2019/11/29
3 Inflammation, low K 2019/11/30
4 Constipation 2019/12/5
5 Scrotal swelling 2019/12/6
参照文献
1. Sweeney CJ, et al., N Engl J Med, 2015, 20;373(8): 737-46
Only one case (No. 1) was able to undergo docetaxel chemotherapy and RALP, but the progression-free survival, the primary endpoint, is 44 months at present. This result was better than the median PFS of 20.2 months in the global phase III clinical trial (STAMPEDE trial) [1]. Furthermore, The case No. 1 is continuing to be progression-free.
In addition, the patient (No.2) who underwent radical irradiation after docetaxel chemotherapy had a progression-free survival of 27 months, which is also favorable.
The secondary endpoints were PSA recurrence-free survival (PSA >0.2ng/mL for PSA relapse criteria) and overall survival. The No.1 case has continued for 44 months and the N0.2 case has continued for 27 months, which are favorable results.
In both cases, the prostate cancer disease was well controlled, and the tumor marker PSA was less than 0.2 ng/mL as shown below.
No.1: December 2022 PSA 0.122 ng/mL (slow PSA increase, but PSA <0.2)
No.2: January 2023 PSA 0.008 ng/mL (good control)
Regarding adverse events, the patients presented only minor reversible events with usual surgical care and docetaxel chemotherapy, and no events unique to this clinical trial occurred.
2023年03月31日
3 IPDシェアリング
/
無
No
/
なし
none
管理的事項
研究の種別
非特定臨床研究
登録日
令和5年4月10日
jRCT番号
jRCT1031180387
1 臨床研究の実施体制に関する事項及び臨床研究を行う施設の構造設備に関する事項
(1)研究の名称
未治療転移性前立腺がんに対する術前ドセタキセル化学療法と根治的前立腺全摘除術の有効性と安全性の検討
Efficacy and safety of preoperative docetaxel chemotherapy and radical prostatectomy for untreated metastatic prostate cancer
転移性前立腺がんに対する術前ドセタキセル化学療法と前立腺全摘除術
preoperative docetaxel chemotherapy and radical prostatectomy for metastatic prostate cancer
(2)研究責任医師(多施設共同研究の場合は、研究代表医師)に関する事項等
堀江 重郎
Horie Shigeo
40190243
/
順天堂大学医学部附属順天堂医院
Juntendo University Hospital
泌尿器科
113-8431
/
東京都文京区本郷3-1-3
3-1-3, Hongo 3 cho-me, Bunkyo-ku, Tokyo
03-3813-3111
shorie@juntendo.ac.jp
永田 政義
Nagata Masayoshi
順天堂大学
Juntendo University
医学部泌尿器科
113-8431
東京都文京区本郷3-1-3
3-1-3, Hongo 3 cho-me, Bunkyo-ku, Tokyo
03-3813-3111
03-5802-1227
m-nagata@juntendo.ac.jp
髙橋 和久
あり
平成31年3月5日
自施設で対応可
(3)研究責任医師以外の臨床研究に従事する者に関する事項
順天堂大学
平鍋 奈々
泌尿器外科学
順天堂大学医学部附属順天堂医院
柳澤 尚武
臨床研究・治験センター 臨床研究支援室
順天堂大学医学部附属順天堂医院
眞野 訓
臨床研究・治験センター 信頼性保証室
順天堂大学医学部附属順天堂医院
野尻 宗子
臨床研究・治験センター 臨床研究支援室
該当なし
該当なし
該当なし
(4)多施設共同研究における研究責任医師に関する事項等
多施設共同研究の該当の有無
なし
2 臨床研究の目的及び内容並びにこれに用いる医薬品等の概要
(1)臨床研究の目的及び内容
転移性前立腺がんへの集学的治療の有効性と安全性評価
2
2019年03月31日
実施期間(終了日)
2025年12月31日
実施予定被験者数
15
試験の種類 /
Study Type
介入研究
Interventional
試験デザイン
Study Design
無作為化 / allocation
非無作為化比較
non-randomized controlled trial
盲検化 /masking
非盲検
open(masking not used)
対照 / control
無治療対照/標準治療対照
no treatment control/standard of care control
割付け / assignment
単群比較
single assignment
研究目的 / purpose
治療
treatment purpose
プラセボの有無
なし
盲検の有無
なし
無作為化の有無
なし
研究対象者の適格基準 / Key inclusion & exclusion criteria
主たる選択基準 / Inclusion Criteria
転移性前立腺がん
metastatic prostate cancer
主たる除外基準 / Exclusion Criteria
去勢抵抗性前立腺がん、既治療前立腺がん
Castration-Resistant Prostate Cancer, treated prostate cancer
年齢下限 / Age Minimum
20歳
20age old
年齢上限 / Age Maximum
80歳
80age old
性別 / Gender
男性
Male
中止基準
ドセタキセルによる合併症
対象疾患名 / Health Condition(s) or Problem(s) Studied
前立腺がん
Prostate Cancer
対象疾患コード / Code
対象疾患キーワード / Keyword
転移性、未治療、ハイリスク
Metastatic, untreated, high-risk
介入の有無
あり
介入の内容 / Intervention(s)
タキサン化学療法、腫瘍減量手術
Taxane chemotherapy, cytoreductive prostatectomy
介入コード / Code
介入キーワード /Keyword
主たる評価項目 / Primary Outcome(s)
無増悪生存率
Progression-free survival
副次的な評価項目 / Secondary Outcome(s)
PSA無再発生存率、周術期安全性、去勢抵抗性までの期間
PSA-recurrence-free survival, perioperative complication rate, time to CRPC(castration-resistant prostate cancer)