1142: Multicenter Phase II Study of Combined Neoadjuvant Docetaxel and Hormone Therapy Prior to Radical Prostatectomy for Patients with High Risk Localized Prostate Cancer: Pathologic Outcomes and 3-Year Follow-Up Analyses

2007 ◽  
Vol 177 (4S) ◽  
pp. 377-377
Author(s):  
Martin E. Gleave ◽  
Kim Chi ◽  
Joseph L. Chin ◽  
Eric Winquist ◽  
Laurence H. Klotz ◽  
...  
2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5060-5060
Author(s):  
W. K. Oh ◽  
P. G. Febbo ◽  
J. P. Richie ◽  
F. M. Fennessy ◽  
G. Scibelli ◽  
...  

5060 Background: Treatment options for high-risk localized prostate cancer remain inadequate, with the majority of pts relapsing despite surgery or radiation therapy. We conducted a phase II multicenter trial of neoadjuvant docetaxel and bevacizumab prior to radical prostatectomy in pts with high risk localized prostate cancer. Methods: Eligibility included any of the following: PSA > 20 ng/ml or PSA velocity > 2 ng/ml/yr, cT3 disease, any biopsy Gleason 8–10, Gleason 7 with T3 disease by endorectal (er) MRI. Also, >50% biopsy cores involved and either Gleason 7 or PSA >10 or cT2 disease were eligible. Pts were treated with docetaxel 70 mg/m2 q 3weeks x 6 cycles and bevacizumab 15 mg/m2 q 3 weeks x 5 cycles. The primary endpoint was erMRI partial response (PR, defined here as >50% decrease in tumor volume) in a single target lesion after chemotherapy. Results: 42 pts were registered and treated with 220 cycles so far. Median age was 55 yrs (range 41–67). Median Gleason score was 8 (69% with Gleason 8–10 cancer). Median PSA was 10.5 ng/ml (range 2.1–72.5). Clinical stage was T2 in 46% and T3 in 32%. Of 23 evaluable pts to date, the median decline in the maximal tumor volume by erMRI was -45% (range -84% to 110%). 9/23 (39%) patients had PR, and only 1 pt had radiographic progression. Any PSA decline was noted in 22/34 (65%) evaluable pts, with 18% having a >50% decline. Treatment was well-tolerated: 2 pts had grade 3 allergic reactions requiring discontinuation, 3 had febrile neutropenia and 1 had grade 3 hyperglycemia. Mild fatigue was common. Only 1 pt stopped treatment because of a rising PSA. To date, 31 pts have had radical prostatectomy. One had intraoperative bladder neck injury and was treated instead with radiation + hormone therapy. A second pt had an intraoperative rectal injury but completed surgery. Conclusions: Neoadjuvant docetaxel and bevacizumab demonstrates clinical evidence of activity in men with high-risk localized prostate cancer, with a 39% PR rate by erMRI and PSA declines noted in 65%. Treatment was well-tolerated. The study is ongoing and updated data on response, toxicity and pathology will be presented. [Table: see text]


2021 ◽  
Author(s):  
Deng Wen ◽  
Zhang Cheng ◽  
Jiang Hao ◽  
Li Yulei ◽  
Liu Xiaoqiang ◽  
...  

Abstract Background To evaluate the functional and oncological efficacy of robot-assisted radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for immediate- and high-risk localized prostate cancer (PCa). Methods 232 patients bearing immediate- and high-risk localized PCa between January 2016 and October 2019 were enrolled according to the inclusion criteria. The perioperative, functional and oncological outcomes were compared between the RARP and LRP groups after applying the propensity-score matching (PM) (1:1) method, which were employed to attenuate the impact of the potential baseline confounders. Results In all, except for 10 patients without a suitable pair, the remaining patients in the LRP group were successfully matched to 85 patients in the RARP arm. All differences in preoperative variables turned to be insignificant after PM. Within the matched cohort, no open conversion was required in both groups. The RARP group was corrected with a significantly shorter mean operative time than the LRP group (p < 0.001). Patients in the RARP arm were also at a lower risk of ≤ Grade II complications than those in the LRP group (p = 0.036). Meanwhile, the proportions of transfusion and ≥ Grade II complications in the RARP group were similar to that in the LRP group (p = 0.192 and p = 1.000, respectively). No significant differences regarding the mean estimated blood loss, rates of pT3 disease and positive surgical margin, median specimen Gleason score and hospital stay length existed between the two groups. RARP vs. LRP tended to a significantly higher percentage of urinary continence at the removal of catheter (p = 0.031), postoperative 6 months (p = 0.043), and last follow-up (p = 0.046). Significant differences were also found between the RARP and LRP arms in erectile function at postoperative 6 months and last follow-up (p = 0.013 and p = 0.009, respectively). The statistical comparability between the two groups was observed in biochemical recurrence-free survival (p = 0.228). Conclusions For surgically managing immediate- and high-risk localized PCa, RARP tended to a lower risk of ≤ Grade II complications and superior functional preservation without cancer control being compromised when comparing with LRP.


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