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Clinical Research

Safety and effectiveness of neoadjuvant luteinizing hormone-releasing hormone agonist plus low-dose estramustine phosphate in high-risk prostate cancer: a prospective single-arm study

Prostate Cancer and Prostatic Diseases volume 15, pages 397–401 (2012)Cite this article

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Abstract

Background:

Radical prostatectomy (RP) has limited cancer control potential for the patient with high-risk prostate cancer (Pca). We prospectively examined the efficacy and safety of neoadjuvant therapy with luteinizing hormone-releasing hormone (LHRH) agonist + low-dose estramustine phosphate (EMP) (LHRH+EMP) followed by RP.

Methods:

High-risk Pca was defined by the D’Amico stratification system. A total of 142 patients with high-risk Pca were enrolled in this trial from September 2005 to March 2011. The LHRH+EMP therapy included administration of LHRH agonist and 280 mg day–1 EMP for 6 months before RP. Pathological cancer-free (pT0) rate on the surgical specimen was the primary end point. Secondary end points were PSA-free survival and toxicity.

Results:

The average patient age was 67.4 years (interquartile range (IQR) 72, 65) and the median initial PSA level was 14.80 ng ml–1 (IQR 26.22, 7.13). The median Gleason score was 9 (IQR 9, 7) and 97 patients (68.3%) had clinical stage T2c or T3. All patients completed 6 months of LHRH+EMP neoadjuvant therapy with no delays in RP. Seven patients (4.9%) achieved pT0. Surgical margins were negative in 125 patients (87.0%). At a median follow-up period of 34.9 months, PSA-free survival was 84.3%. No serious adverse events were reported during the study and there were no toxicity-related deaths.

Conclusions:

Six months of LHRH+EMP neoadjuvant therapy followed by RP is safe and oncological outcomes are acceptable. Although this study was a single-arm trial with a relatively short follow-up, this treatment may have a potential to improve PSA-free survival in high-risk Pca patients. Further clinical trials are warranted.

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Authors and Affiliations

  1. Department of Urology, Hirosaki University, Graduate School of Medicine, Hirosaki, Japan

    T Koie, C Ohyama, H Yamamoto, S Hatakeyama, T Yoneyama, Y Hashimoto & N Kamimura

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  1. T Koie
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Correspondence to C Ohyama.

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Koie, T., Ohyama, C., Yamamoto, H. et al. Safety and effectiveness of neoadjuvant luteinizing hormone-releasing hormone agonist plus low-dose estramustine phosphate in high-risk prostate cancer: a prospective single-arm study. Prostate Cancer Prostatic Dis 15, 397–401 (2012). https://doi.org/10.1038/pcan.2012.29

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