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    v: **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.
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type:
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    code:
      v: mesh-heading
    display:
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artifact assessment:
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type:
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      l: cited-artifact-classification-type
    code:
      v: publication-type
    display:
      v: Publication type
classifier:
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    system:
      v: https://www.nlm.nih.gov/mesh
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    code:
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    display:
      v: Clinical Trial, Phase II
    user selected:
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classifier:
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    code:
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    display:
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    user selected:
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classifier:
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    code:
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    display:
      v: Randomized Controlled Trial
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classifier:
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    user selected:
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type:
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    code:
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    display:
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classifier:
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    display:
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artifact assessment:
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type:
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classifier:
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complete:
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entry:
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    reference:
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    type:
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    display:
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  affiliation:
    display:
      v: Institute of Cancer Sciences, University of Glasgow, UK. Electronic address: p.rajan@beatson.gla.ac.uk.
entry:
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    type:
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    display:
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  forename initials:
    v: JA
  affiliation:
    display:
      v: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry:
  contributor:
    l: contributor2
    reference:
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    type:
      v: Practitioner
      l: Practitioner
    display:
      v: Wilson JM
  forename initials:
    v: JM
  affiliation:
    display:
      v: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry:
  contributor:
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    reference:
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    type:
      v: Practitioner
      l: Practitioner
    display:
      v: Azzabi AS
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    v: AS
  affiliation:
    display:
      v: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry:
  contributor:
    l: contributor4
    reference:
      v: #contributor4
    type:
      v: Practitioner
      l: Practitioner
    display:
      v: McMenemin RM
  forename initials:
    v: RM
  affiliation:
    display:
      v: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry:
  contributor:
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    type:
      v: Practitioner
      l: Practitioner
    display:
      v: Stockley J
  forename initials:
    v: J
  affiliation:
    display:
      v: Institute of Cancer Sciences, University of Glasgow, UK.
entry:
  contributor:
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    reference:
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    type:
      v: Practitioner
      l: Practitioner
    display:
      v: Soomro NA
  forename initials:
    v: NA
  affiliation:
    display:
      v: Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry:
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    reference:
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    type:
      v: Practitioner
      l: Practitioner
    display:
      v: Durkan G
  forename initials:
    v: G
  affiliation:
    display:
      v: Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry:
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    type:
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      l: Practitioner
    display:
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    display:
      v: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
entry:
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    reference:
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    type:
      v: Practitioner
      l: Practitioner
    display:
      v: Leung HY
  forename initials:
    v: HY
  affiliation:
    display:
      v: Institute of Cancer Sciences, University of Glasgow, UK; Cancer Research UK Beatson Institute, Bearsden, UK. Electronic address: h.leung@beatson.gla.ac.uk.