Phase II Study of Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for Patients With High-Risk Localized Prostate Cancer Prior to Radical Prostatectomy

Uncategorized

Phase II Study of Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for Patients With High-Risk Localized Prostate Cancer Prior to Radical Prostatectomy

Condition: Prostate Cancer

Intervention:

  • Drug: Goserelin
  • Drug: Prednisone
  • Drug: Abiraterone
  • Drug: Apalutamide

Purpose: This is a randomized study to evaluate the efficacy and safety neoadjuvant androgen deprivation therapy with goserelin and abiraterone with or without apalutamide prior to radical prostatectomy for patients diagnosed with localized high-risk prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02789878

Sponsor: Instituto do Cancer do Estado de São Paulo

Primary Outcome Measures:

  • Measure: Pathologic response
  • Time Frame: 3 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Residual cellularity rate
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: Pathologic downgrading
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: PSA decline rate
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: Rate of positive surgical margins
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: Rate of undetectable PSA
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Rate of Grade ≥ 3 CTCAE adverse events
  • Time Frame: 3 months
  • Safety Issue:

Estimated Enrollment: 64

Study Start Date: January 24, 2019

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 80 Years
  • Gender: Male

Inclusion Criteria:

  • Histologic confirmed prostatic adenocarcinoma
  • Non-castrate levels of testosterone (> 150 ng/dL)
  • High-risk localized prostate cancer, defined by either:
  • Tumor stage T3 by digital rectal examination, or
  • Primary tumor Gleason score ≥ 8, or
  • PSA ≥ 20 ng/mL
  • Willing to undergo prostatectomy as primary treatment for localized prostate cancer
  • Adequate hematologic, renal and hepatic function:
  • WBC > 3000/uL
  • Platelets > 150,000/uL
  • Creatinine < 2 mg/dL
  • Bilirubin < 1.5 x upper limit of normal (ULN)
  • AST/ALT < 2 x ULN
  • Karnofsky Performance Status (KPS) ≥ 80%
  • Able to swallow the study drugs whole as tablets

Exclusion Criteria:

  • Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
  • Current or prior hormonal therapy, radiation therapy or chemotherapy for prostate cancer
  • Evidence of metastatic disease (M1) on imaging studies
  • Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma
  • Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure
  • History of prior cardiac arrhythmia.
  • Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.

Contact:

  • Diogo A Bastos, MD
  • +55 11 38932691

Location:

  • Instituto do Cancer do Estado de Sao Paulo
  • Sao Paulo SP 01246-0000 Brazil

View trial on ClinicalTrials.gov

X