Phase II trial of short-term neoadjuvant docetaxel and complete androgen blockade in high-risk prostate cancer

B. Mellado*, A. Font, A. Alcaraz, L. A. Aparicio, F. J. G. Veiga, J. Areal, E. Gallardo, N. Hannaoui, J. R. M. Lorenzo, A. Sousa, P. L. Fernandez, P. Gascon

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

37 Citations (Scopus)


BACKGROUND: The low probability of curing high-risk prostate cancer (PC) with local therapy suggests the need to study modality of therapeutic approaches. To this end, a prospective phase II trial of neoadjuvant docetaxel (D) and complete androgen blockade (CAB) was carried out in high-risk PC patients. The primary end point was to detect at least 10% of pCRs after chemohormonal treatment.

METHODS: Patients with T1c-T2 clinical stage with prostate-specific antigen (PSA) >20 ng ml(-1) and/or Gleason score >= 7 (4 + 3) and T3 were included. Treatment consisted of three cycles of D 36 mg m(-2) on days 1, 8 and 15 every 28 days concomitant with CAB, followed by radical prostatectomy (RP).

RESULTS: A total of 57 patients were included. Clinical stage was T1c, 11 patients (19.3%); T2, 30 (52.6%) and T3, 16 (28%) patients. Gleason score was >= 7 (4 + 3) in 44 (77%) patients and PSA >20 ng ml(-1) in 15 (26%) patients. Treatment was well tolerated with 51 (89.9%) patients completing neoadjuvant therapy together with RP. The rate of pCR was 6% (three patients). Three (6%) additional patients had microscopic residual tumour (near pCR) in prostate specimen. With a median follow-up of 35 months, 18 (31.6%) patients presented PSA relapse.

CONCLUSION: Short-term neoadjuvant D and CAB induced a 6% pCR rate, which is close to what would be expected with ADT alone. The combination was generally well tolerated. British Journal of Cancer (2009) 101, 1248-1252. doi:10.1038/sj.bjc.6605320 Published online 15 September 2009 (C) 2009 Cancer Research UK

Original languageEnglish
Pages (from-to)1248-1252
Number of pages5
JournalBr. J. Cancer
Issue number8
Publication statusPublished - 13 Oct 2009


  • prostate cancer
  • high risk
  • neoadjuvant therapy
  • docetaxel


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