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


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02543255

Sponsor: University Health Network, Toronto

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Willing and able to provide informed consent;
  • Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features with a minimum of 3 cores positive for tumour;
  • Tumour biopsy tissue accessible for downstream evaluation;
  • Must be candidates for radical prostatectomy and considered surgically resectable by urologic evaluation;
  • High Risk D'Amico score defined as either PSA > 20, Gleason score ≥ 8 as determined by the local pathologist; or T2c-3 based on DRE, pathologic review +/- imaging;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
  • No evidence of metastatic disease or nodal disease as determined by radionuclide bone scans and computed tomography (CT)/magnetic resonance imaging (MRI); non-pathological lymph nodes must be less than 15 mm in the short (transverse) axis;
  • Able to swallow the study drug(s) as prescribed and comply with study requirements;
  • Required initial laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1500/μL;
  • Platelet count ≥ 100,000/μL;
  • Hemoglobin ≥ 90 g/L;
  • Creatinine ≤ 175 μmol/L;
  • Bilirubin ≤ upper limit of institutional normal (ULN);
  • AST/ALT ≤ 1.5 × ULN.

Exclusion Criteria:

  • Received an investigational agent within 4 weeks prior to screening;
  • Stage T4 prostate cancer by clinical examination or radiologic evaluation;
  • Hypogonadism or severe androgen deficiency as defined by screening serum testosterone below the normal range for the institution;
  • Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer;
  • Receiving concurrent androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to randomization;
  • History of another malignancy within the previous 5 years other than curatively treated nonmelanomatous skin cancer and non-muscle invasive bladder cancer;
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiovascular disease, unstable angina pectoris, cardiac arrhythmia that is symptomatic or requires active therapy; deep venous thrombosis within 3 months prior to randomization;
  • Previous use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., enzalutamide, BMS 641988);
  • Liver injury or disease (e.g., viral hepatitis, liver failure Child‐Pugh Class C).

View trial on ClinicalTrials.gov