Protocol for CHAMPION study
Practical Solutions and Value
The CHAMPION study aims to assess the effectiveness of a multi-modal treatment approach for newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) patients with a limited number of distant metastatic sites. The study focuses on the use of PSMA PET/CT-guided cytoreduction in combination with apalutamide and androgen deprivation therapy (ADT) to improve patient prognosis.
Study Details
CHAMPION (NCT05717582) is an open-label, single-arm, phase II trial enrolling mHSPC cases with ≤ 10 distant metastatic sites. Patients will receive 6 cycles of apalutamide plus ADT. Those with oligometastatic disease at PSMA PET/CT after 3 treatment cycles will undergo cytoreductive radical prostatectomy. The primary endpoint is to determine the proportion of patients with undetectable PSA, no disease progression, and no symptom deterioration after 6 cycles of treatment. Secondary endpoints include PSA response rate and safety.
Study Design
The study will utilize Fleming’s two-stage group sequential design. With one-sided α = 0.05, power = 0.80, and an assumed dropout rate of 10%, the required number of patients for analysis is 47. Enrolment commenced in May 2023.
Implications
The results of this study may provide insights into the potential benefits of a multi-modal treatment approach for mHSPC patients with oligometastases, contributing to the development of improved therapeutic strategies.
