Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial)

Official Title

Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC-RP Trial): A Randomized, Open-label, Multi-centre Phase-2 Study Evaluating the Pathological Complete Response (pCR) Rate Following Neoadjuvant Therapy in Participants With High-risk Prostate Carcinoma for Whom Radical Prostatectomy is Indicated

Summary:

This study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in patients with high-risk prostate carcinoma. Half of the participants will receive treatment with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will receive only abiraterone acetate, prednisone, and leuprolide.

Trial Description

Primary Outcome:

  • Pathological complete response
Secondary Outcome:
  • Pre-operative PSA levels
  • Mean nadir PSA levels
  • Percentage of participants achieving a PSA < 0.2 ng/mL
  • Percentage of participants achieving a 50 and 90% decrease in PSA levels
  • Rate of positive surgical margins
  • Rate of near-complete response (<5 mm tumour)
  • Rate of extracapsular extension
  • Rate of positive seminal vesicle involvement
  • Rate of nodal involvement
  • Tumour proliferation (Ki-67 index)
  • Androgen receptor expression
  • Incidence of adverse events
  • Severity of adverse events
  • Androgen levels (if optional biopsy tissue is available)
  • Genomic alterations between pre- and post-treatment tissue

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society