Docetaxel Versus Surveillance After Radical Prostatectomy for High-risk Prostate Cancer: Results from the Prospective Randomised, Open-label Phase 3 Scandinavian Prostate Cancer Group 12 Trial

Research output: Contribution to journalArticle

Abstract

Background: Adjuvant chemotherapy is standard treatment for other solid tumours, but to date has not proven effective in prostate cancer. Objective: o evaluate whether six cycles of docetaxel alone improve biochemical disease-free survival after radical prostatectomy for high-risk prostate cancer. Design, setting, and participants: Open-label, randomised multinational phase 3 trial. Enrolment of 459 patients after prostatectomy. Inclusion criteria: high-risk pT2 margin positive or pT3a Gleason score ≥4+3, pT3b, or lymph node positive disease Gleason score ≥3+4. Patients assigned (1:1) to either six cycles of adjuvant docetaxel 75mg/m2 every 3 wk without daily prednisone (Arm A) or surveillance (Arm B) until endpoint was reached. Primary endpoint was prostate-specific antigen progression ≥0.5 ng/ml. Intervention: Docetaxel treatment after prostatectomy. Results and limitations: Median time to progression, death, or last follow-up was 56.8 mo. Primary endpoint was reached in 190/459 patients-the risk of progression at 5 yr being 41% (45% in Arm A and 38% in Arm B). There was evidence of nonproportional hazards in Kaplan-Meier analysis, so we used the difference in restricted mean survival time as the primary estimate of effect. Restricted mean survival time to endpoint was 43 mo in Arm A versus 46 mo in Arm B (p = 0.06), a nonsignificant difference of 3.2 mo (95% confidence interval: 6.7 to -1.5 mo). A total of 116 serious adverse events were recorded in Arm A and 41 in Arm B with no treatment-related deaths. Not all patients received docetaxel by protocol. The endpoint is biochemical progression and some patients received radiation treatment before the endpoint. Conclusions: Docetaxel without hormonal therapy did not significantly improve biochemical disease-free survival after radical prostatectomy. Patient summary: In this randomised trial, we tested whether chemotherapy after surgery for high-risk prostate cancer decreases the risk of a rising prostate-specific antigen. We found no benefit from docetaxel given after radical prostatectomy. In this randomised trial, docetaxel without hormonal therapy or continuous corticosteroids was given after radical prostatectomy for high-risk prostate cancer. We found no benefit from docetaxel alone given after radical prostatectomy.

Details

Authors
  • Göran M. Ahlgren
  • Per Flodgren
  • Teuvo L.J. Tammela
  • Pirkko Kellokumpu-Lehtinen
  • Michael Borre
  • Anders Angelsen
  • Jon Reidar Iversen
  • Asgerdur Sverrisdottir
  • Eirikur Jonsson
  • Lisa Sengelov
Organisations
External organisations
  • Skåne University Hospital
  • University of Tampere
  • Aarhus University Hospital Skejby
  • Norwegian University of Science and Technology
  • Oslo university hospital
  • National University Hospital of Iceland
  • Gentofte Hospital
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cancer and Oncology

Keywords

  • Adjuvant, Docetaxel, Prostate cancer, Radical prostatectomy, Randomised trial
Original languageEnglish
Pages (from-to)870-876
JournalEuropean Urology
Volume73
Issue number6
Publication statusPublished - 2018
Publication categoryResearch
Peer-reviewedYes