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Efficacy and safety of preoperative docetaxel chemotherapy and radical prostatectomy for untreated metastatic prostate cancer

preoperative docetaxel chemotherapy and radical prostatectomy for metastatic prostate cancer

2

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

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.

Mar. 31, 2023

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCT1031180387

Horie Shigeo

Juntendo University Hospital

3-1-3, Hongo 3 cho-me, Bunkyo-ku, Tokyo

shorie@juntendo.ac.jp

Nagata Masayoshi

Juntendo University

3-1-3, Hongo 3 cho-me, Bunkyo-ku, Tokyo

+81-3-3813-3111

m-nagata@juntendo.ac.jp

Complete

Mar. 14, 2019

Interventional

non-randomized controlled trial

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

metastatic prostate cancer

Castration-Resistant Prostate Cancer, treated prostate cancer

Male

Prostate Cancer

Taxane chemotherapy, cytoreductive prostatectomy

Metastatic, untreated, high-risk

Progression-free survival

PSA-recurrence-free survival, perioperative complication rate, time to CRPC(castration-resistant prostate cancer)

+81-3-5802-1584

Mar. 05, 2019

none