Results of a unicenter randomized study of the safety and efficiency of docetaxel chemotherapy before radical prostatectomy in patients with intermediate- and high-risk prostate cancer: An 11.4-year follow-up

Objective. Our retrospective study is aimed to assess safety, pathological response rate, and long-term oncologic outcomes of radical prostatectomy after neoadjuvant chemotherapy for intermediate- to high-risk PCa.

Materials and methods. Forty-four patients were involved in this study, with a 11.4-year follow-up period, on average. We assessed the RPE results in patients with intermediate and high risk of prostate cancer (PSA>10 ng/ml, Gleason score 7 and more, or clinical stage cT2c and more) after weekly treatment with docetaxel (36 mg/m2 for up to 6 cycles, 21 patients) and compared them with those in the second cohort (23 patients) who met oncologic inclusion criteria but received radical prostatectomy only. The long-term oncologic outcomes in both groups of the patients are reported.

Results. Toxicity has been mostly grade 1-2 in intensity and grade 3 and more complication rate does not exceed 10%. A statistically significant of more than 50% reduction in PSA level (pre- vs. post-chemotherapy) was observed in 52.4% cases. During the 11.4-year follow-up period, improvement in cancer-specific survival (CSS) was noted in 90% of patients from the neoadjuvant chemotherapy group, as compared with 60.9% in radical prostatectomy only group. The biochemical recurrence-free survival (BCR) was 68.5 % and 37.7 %, and the overall survival (OS) was 75.5 % and 54.6 % in the combined treatment group and surgery only group, respectively. However, the differences in BCR and OS were not statistically significant.

Conclusion. The use of neoadjuvant chemotherapy represents a safe and practicable treatment strategy resulting in reduced prostate volume and PSA level. Neoadjuvant docetaxel chemotherapy followed by radical prostatectomy was associated with higher observed BCR and OS, as compared with a surgical treatment only group. A statistically significant improvement of CSS is found in the combined treatment group. Therefore, the benefits of this treatment modality need to be validated for feasible implementation in the modern standard practices of prostate cancer treatment.