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Protocol No. EA8153

Principal Investigator Kyriakopoulos, Christos

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial

Objective The purpose of this research study is to compare any good or bad effects of using the chemotherapy drug cabazitaxel (also known as Jevtana®) with the usual approach of the hormone based therapy abiraterone acetate (also known as Zytiga®) in combination with prednisone on patients with advanced prostate cancer that have already undergone treatment with hormone therapy and the chemotherapy drug docetaxel. In this research study, you will get either the standard of care combination of abiraterone acetate and prednisone, or you will get abiraterone acetate and prednisone in combination with the chemotherapy drug cabazitaxel. To be better, the study drug should delay the development of resistance to abiraterone acetate and prednisone by 6 months or more compared to the usual approach

Treatment
Group A will receive the study drug cabazitaxel in addition to the standard of care combination of abiraterone acetate and prednisone
Group B will receive the standard of care combination of abiraterone acetate and prednisone

Description Randomized trial of Cabazitaxel with Abiraterone versus Abiraterone alone

Key Eligibility
  • Age ≥ 18 years
  • Histologically confirmed diagnosis of prostate cancer(adenocarcinoma of the prostate).
  • Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer
  • Metastatic disease
  • All patients must be receiving standard of care androgen deprivation treatment (surgical castration versus LHRH agonist or antagonist treatment); subjects receiving LHRH agonist or antagonist must continue treatment throughout the time on this study
  • Patients must have castrate serum level of testosterone of < 50 ng/dL
  • Patients must have an ECOG performance status of 0, 1, or 2
  • Adequate hematologic and renal function
  • Sexually active males must use an accepted and effective method of birth control
  • No prior chemotherapy or AR-directed therapy for CRPC, (e.g. docetaxel, cabazitaxel, mitoxantrone, abiraterone acetate, ketoconazole, or enzalutamide)
  • Previous treatment with radium-223 or sipuleucel-T is allowed
  • Any medical condition for which prednisone (corticosteroid) is contraindicated
  • No active infection requiring treatment with antibiotics
  • No history of adrenal insufficiency or hypoaldosteronism
  • No Myocardial infarction or arterial thrombotic event within 6 months
  • No prior history of active secondary malignancy
  • No grade ≥ 2 neuropathy

  • Applicable Disease Sites Prostate

    Status Open

    Participating Institutions Johnson Creek, UW Cancer Center; UW Hospital and Clinics; UWCCC 1 South Park