title: Phase II trial of short-term neoadjuvant docetaxel and complete androgen blockade in high-risk prostate cancer.
abstract: 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 >or=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 >or=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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Medical Oncology Department, Hospital Clinic, Barcelona, Spain. bmellado@clinic.ub.es
authors.forename: B
authors.initials: B
authors.lastname: Mellado
authors.forename: A
authors.initials: A
authors.lastname: Font
authors.forename: A
authors.initials: A
authors.lastname: Alcaraz
authors.forename: L A
authors.initials: LA
authors.lastname: Aparicio
authors.forename: F J G
authors.initials: FJ
authors.lastname: Veiga
authors.forename: J
authors.initials: J
authors.lastname: Areal
authors.forename: E
authors.initials: E
authors.lastname: Gallardo
authors.forename: N
authors.initials: N
authors.lastname: Hannaoui
authors.forename: J R M
authors.initials: JR
authors.lastname: Lorenzo
authors.forename: A
authors.initials: A
authors.lastname: Sousa
authors.forename: P L
authors.initials: PL
authors.lastname: Fernandez
authors.forename: P
authors.initials: P
authors.lastname: Gascon
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000077143:Docetaxel; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D000726:Androgen Antagonists; D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel