Perioperative Morbidity of Radical Prostatectomy After Intensive Neoadjuvant Androgen Blockade in Men With High-Risk Prostate Cancer: Results of Phase II Trial Compared to a Control Group

•Intense neoadjuvant therapy doesn't increase the morbidity of radical prostatectomy.•Neoadjuvant therapy reduced the rate of positive surgical margins.•Neoadjuvant therapy may increase the risk of perioperative thromboembolic events. Recent studies about intense neoadjuvant therapy followed by...

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Published in:	Clinical genitourinary cancer Vol. 21; no. 1; pp. 43 - 54
Main Authors:	Ilario, Eder N., Bastos, Diogo A., Guglielmetti, Giuliano B., Murta, Claudio B., Cardili, Leonardo, Cordeiro, Mauricio D., Junior, Jose P., Coelho, Rafael F., Nahas, William C.
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-02-2023
Subjects:	Abiraterone acetate plus prednisone Androgen Antagonists - adverse effects Androgens Apalutamide Control Groups Humans Male Morbidity Neoadjuvant therapy Neoadjuvant Therapy - adverse effects Positive surgical margin Prospective Studies Prostate-Specific Antigen Prostatectomy - adverse effects Prostatectomy - methods Prostatic Neoplasms - drug therapy Prostatic Neoplasms - surgery Thromboembolic events Treatment Outcome Apalutamide Neoadjuvant therapy Thromboembolic events Abiraterone acetate plus prednisone Positive surgical margin
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Summary:	•Intense neoadjuvant therapy doesn't increase the morbidity of radical prostatectomy.•Neoadjuvant therapy reduced the rate of positive surgical margins.•Neoadjuvant therapy may increase the risk of perioperative thromboembolic events. Recent studies about intense neoadjuvant therapy followed by Radical Prostatectomy (RP) lack standardized criteria regarding surgical complications and comparison to a group of patients who underwent RP without the use of neoadjuvant therapy. The aim of this study is to describe and compare the perioperative complication rates. This was a prospective, single-center phase II trial in patients with high-risk prostate cancer (HRPCa). The control group included HRPCa patients who underwent RP outside the clinical trial during the same study recruitment period. The interventional group was randomized (1:1) to receive neoadjuvant androgen deprivation therapy plus abiraterone with or without apalutamide followed by RP. Complications observed up to 30 days of surgery were classified based on the Clavien-Dindo classification. Uni- and multivariate analyses were carried out to assess predictive factors associated with perioperative complications. In total, 124 patients with HRPCa were underwent to RP between May 27, 2019 and August 6, 2021, including 61 patients in the intervention group and 63 patients in the control group. The general and major complications in the intervention group reached 29.6% and 6.6%, respectively, and 39.7% and 7.9% in the control group, respectively. There was no significant difference between groups. We observed 4.9% of thromboembolic event in the neoadjuvant group. There was no significant increase in morbidity rate in RP after intense neoadjuvant therapy. The association of intense androgen deprivation neoadjuvant therapy with RP and extended pelvic lymphadenectomy may increase the risk of a perioperative thromboembolic events. In this study, we investigated whether intense neoadjuvant therapy could increase the risk of complications in radical prostatectomy. After analyzing 124 patients we concluded that intense neoadjuvant therapy doesn't increase morbidity of radical prostatectomy and reduces positive surgical margins. The association of neoadjuvant therapy with extended pelvic lymphadenectomy may increase the risk of perioperative thromboembolic events.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3
ISSN:	1558-7673 1938-0682
DOI:	10.1016/j.clgc.2022.10.009