Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non–castration-resistant prostate cancer

Rajan, P., Frew, J. A., Wilson, J. M., Azzabi, A. S.T., McMenemin, R. M., Stockley, J., Soomro, N. A., Durkan, G., Pedley, I. D. and Leung, H. Y. (2015) Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non–castration-resistant prostate cancer. Urologic Oncology: Seminars and Original Investigations, 33(8), 337.e1-337.e6. (doi: 10.1016/j.urolonc.2015.05.012) (PMID:26092557)

Abstract

Background and objective: Sequential tissue biopsies taken during clinical trials of novel systemic anticancer therapies for advanced prostate cancer (PCa) may aid pharmacodynamic evaluation and biomarker discovery. We conducted a single institution phase-II open-labeled randomized study to assess the safety, tolerability, and early efficacy of docetaxel chemotherapy plus androgen deprivation therapy (ADT) vs. ADT alone for patients with advanced non–castration-resistant PCa with sequential prostatic biopsies. Patients and methods: We randomized 30 patients with newly diagnosed high-grade locally advanced or metastatic (cT3–4/N0–1/M0–1) PCa to receive ADT with (n = 15) or without (n = 15) docetaxel. Transrectal ultrasound–guided prostatic biopsies were taken at randomization and ~22 weeks after treatment initiation. Primary end point: biochemical response rate. Secondary end points: time to progression and tumor profiling. Results: Both treatments appear to be well tolerated, and there was no difference in mean nadir prostate-specific antigen and time to prostate-specific antigen relapse between treatment arms (P>0.05). No adverse effects of pre- and post-treatment prostatic biopsies were observed. The study was neither designed nor sufficiently powered to demonstrate statistically significant differences in oncological outcomes or safety profiles between the 2 treatment arms. Conclusions: Despite the lack of statistical power, our study suggests that docetaxel and ADT in combination may be well tolerated with apparently similar short-term efficacy compared with ADT alone for high-grade locally advanced or metastatic non–castration-resistant PCa, Sequential prostatic biopsies may provide tissue for tumor profiling to yield mechanistic or prognostic insights relating to novel systemic anticancer therapies.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Leung, Professor Hing
• Authors: Rajan, P., Frew, J. A., Wilson, J. M., Azzabi, A. S.T., McMenemin, R. M., Stockley, J., Soomro, N. A., Durkan, G., Pedley, I. D., and Leung, H. Y.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: Urologic Oncology: Seminars and Original Investigations
• Publisher: Elsevier
• ISSN: 1078-1439
• ISSN (Online): 1078-1439
• Published Online: 16 June 2015